VOLUME 20, ISSUE 1: JUNE 2020

INSIDE THIS ISSUE The NIAID-funded HIV Vaccine Trials Network (HVTN) Responds to COVID-19 1 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 LETTERcities have some sort of “Stay at Please help us ensure that this Home” order* in place. On social publication is representative of our media, I see posts daily from people entire global HVTN community! who express concerns about (or HVTN members (who have access barriers to) getting tested; concerns to the HVTN member’s website) about themselves, friends, or family can use our submission page members who have possible or that offers the ability to submit actual symptoms of the virus; and content and articles for inclusion have seen just as many posts about in future issues. More information people who have died as a result of about this follows on the “Meet the complications of COVID-19. As I Community Compass Team” page. have sat and pondered about what to pen for this letter, I have thought Thank you for your continued Stephaun E. Wallace, Editor-in-Chief many times about the relationship support of the HVTN wherever you [email protected] between this disease and others, are in the world, for the work that Welcome to the latest edition of the including HIV, specifically for you do in whatever role you have HIV Vaccine Trials Network (HVTN) people and communities who are in the HVTN community, and for Community Compass. more vulnerable to negative health the impact we have been able to outcomes due to oppressive systems make in our collective history and In this issue, we highlight some and structures. Similar to HIV and communities, together. Though we of the recent World AIDS Day many other diseases, COVID-19 have come very far in response to activities, updates from some of our illustrates the very real impacts the HIV epidemic, we have so much sites and about some of our studies, of bias in healthcare/medical further to go to achieve an effective dive deeper into upcoming phase systems, poverty, historical trauma, global HIV vaccine. The HVTN 1 broadly neutralizing studies, as and other conditions impacting Community Compass team wants well as a very personal interview many communities, including to be everywhere you are, so please with our very own Dr. Larry Corey. communities of color. share with us what’s happening at The novel coronavirus SARS-CoV-2 your research sites, institutions, and which can result in COVID-19 I believe we will see this pandemic in your communities, so that we can disease has also cut short the life end, but we cannot achieve this end share it with the world. of one of our beloved colleagues, ethically by leaving anyone behind, Professor Gita Ramjee, who, in or without ensuring that appropriate Be well, addition to having been a renowned efforts are focused on those who are Stephaun E. Wallace scientist and role model to many, most vulnerable. There are many Stephaun E. Wallace, Ph.D. also served as Chief Specialist stakeholder mobilization efforts Editor-in-Chief, HVTN Community Compass Scientist and Director of the HIV happening in local and national Prevention Research Unit of the settings around the world with goals South African Medical Research of raising awareness about these Note: This was true at the time Council in Durban, South Africa. issues, and ensuring resources and of writing in April 2020. Please solutions are inclusive of those follow your institutional guidance The COVID-19 pandemic has taken most impacted and vulnerable. regarding any updates on center stage, becoming the topic We are a global community; let COVID-19 in your location. of conversation in nearly every us work together in response virtual space that I access. Many to this pandemic.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 2 CONTENTS

Meet The Community Compass Team 4

Hope and a “Queen” 5

In Harmony - Transgender People and Early Phase HIV Vaccine Trials 8

Upcoming Events/Conferences/Meetings 10

Responding to a Four-Decade Old Epidemic While Thwarting the “New Kid on the Block” 11

Facing Down Pandemics: Dr. Larry Corey on HIV and COVID-19 15

The HVTN and HPTN Remember Gita Ramjee 17

Phase 1 Broadly Neutralizing Antibody Efforts 18

New SBS-CEU Staff at HVTN Core 22

Getting the Right Test for HIV 23

World AIDS Day Commemoration Event Report December 2019 Hosted By Synexus 25

Setshaba Research Centre World AIDS Day Commemoration 2019 28

Updates at Vanderbilt CRS 30

Mosaico: A Fleeting 72 Hours Inscribed to Memory 31

Public statement by the HIV Vaccine Trials Network (HVTN) on COVID-19 35

3 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Our vision is an informed HVTN community that is aware of current events and activities relating to the HVTN network and its sites, advances in the field of HIV prevention and vaccination, as well as community priorities. We work to accomplish this by providing relevant information and updates to promote awareness, understanding, and support for HIV prevention and HIV vaccines, reaching global communities invested in the response to the HIV epidemic.

We welcome submissions of articles on any topic for publication that is relevant to the HVTN community. Submissions must be exclusive to us, and not appear in any other publication. Submissions must be 500 words or less to comply with our layout and design requirements.Due to space limitations, we may need to hold publishing your article for a future issue.

To submit articles for Community Compass, please go to the HVTN Members Site homepage, click on “About”, then click “Community Compass”, then click on “Submit to Community Compass”.

Stephaun E. Wallace, Ph.D. Cody Shipman, Nina Feldman, Editor-in-Chief Layout & Design Production & Distribution

Aziel Gangerdine, Gail Broder, MHS Contributor Contributing Editor

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 4 Featured Article Hope and a “Queen”

By: Aziel Gangerdine, HVTN Core, Seattle, WA, USA Communities, scientists, The Story of Science prevention, and HIV counseling investigators in the field of HIV and testing is mired with prevention, and other stakeholders A preventive vaccine that is safe challenges. Among others, HIV is are likely anticipating the and globally effective against HIV is a retrovirus with a high mutation announcement of the preliminary to HIV prevention research what a rate, and it targets the same T-cells results of two large-scale HIV queen represents on a chessboard. the immune system needs to prevention studies later this year. On the chessboard the queen is activate the immune system to Notably branded as AMP, antibody a game changer as it moves any fight infection. Additionally, a safe mediated prevention, both studies number of squares vertically, and effective HIV vaccine must are designed to determine whether horizontally and diagonally. prevent the transmission of the a broadly neutralizing antibody Similarly, a vaccine against HIV varying subtypes of HIV that are called VRC01 can prevent the will change the game by offering a found throughout the world. transmission of HIV in people. new long-lasting HIV prevention option, which may mitigate the The proof-of-concept AMP studies Fittingly, the NIAID-funded HIV need for daily medication like are not HIV vaccine studies. In HIV Vaccine Trials Network (HVTN), PrEP or post-exposure prophylaxis vaccine trials, study participants together with its our partners at (PEP) for some people; could get an HIV vaccine regimen and the HIV Prevention Trials Network offer herd immunity that protects researchers evaluate if vaccine- (HPTN) and the study funder and individual who get vaccinated induced antibodies and cellular sponsor the National Institute of and their communities; and immune responses are elicited Allergy and Infectious Diseases could potentially prevent the that may prevent HIV infection. (NIAID) of the National Institutes of asymptomatic transmission of The AMP studies skip that step Health (NIH), will lead discussions HIV from an infected person who by administering an antibody when the preliminary results of is not aware that they are infected through IV infusion directly the Antibody Mediated Prevention to others. In developing countries into the bloodstream of study (AMP) studies are shared. an HIV vaccine has the potential participants, looking to see if to alleviate pressure on poor having the antibodies will be Two interdependent stories will be social and health infrastructure protective. If efficacy is found, at the heart of the announcement: that is already under tremendous they will also help to establish the the stories of science and the will pressure from other diseases such amount of antibodies one needs and hope of communities. These as Tuberculosis (TB), diabetes in order to achieve protection. stories will be told through the and cancer. The socioeconomic By determining the amount of voices of the 4,625 AMP study benefits to any one society will antibodies needed to prevent HIV, participants, consisting of women be tremendous if an HIV vaccine this will help vaccine researchers in sub-Saharan Africa between is introduced to scale and made set a target for the amount of the ages of 18 – 40 years, and men accessible to communities. History antibodies that a future HIV and transgender people between reminds us that smallpox was vaccine may need to elicit. Having the ages of 18 – 50 years in the eradicated by a vaccine. In the this kind of target could help make Americas and Switzerland who United States, a long list of diseases future development of a vaccine have sex with men. These stories such as diphtheria, measles, more efficient and cost effective. will color a canvas set against mumps, rubella, and tetanus near a backdrop of the world’s HIV eradication as a result of vaccines. The Will and Hope epicenter in a venue likely to of Communities have limited seating and an The pursuit to add the “queen” air of anticipation. to existing HIV prevention In early February 2020, the Network strategies such as voluntary male stopped all vaccinations in its circumcision, PrEP, internal and HVTN 702 vaccine trial. An interim external condoms, treatment for analysis showed that while the

5 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 vaccine was safe, it was showing impact lives in spite of significant the dedicated communities from no efficacy at all. Conducted in progress in treatment and Botswana, Brazil, Kenya, Malawi, South Africa, the trial enrolled more prevention. In 2018 UNAIDS Mozambique, Peru, South Africa, than 5,400 HIV-negative men and estimated there to have been more Switzerland, Tanzania, the United women between the ages of 18-35 than 74 million HIV transmissions States, and Zimbabwe who were years. The news dashed hopes for and 32 million deaths since a part of a global response to end this HIV vaccine regimen against the epidemic began. The need the pandemic. subtype C, the predominantly for a safe and globally effective circulating strain of HIV in sub- preventive HIV vaccine cannot The HIV prevention field will move Saharan Africa. A somber mood be emphasized enough. forward, regardless of the AMP set into communities, amongst outcome. We will learn as a global stakeholders, and the scientific In the future, history will remind community, and remain steadfast community. us of the scientific and people- in our commitment to the pursuit centered lessons learned from for a safe and globally effective In 1909 polio was discovered and HVTN 702 and the other previous preventive HIV vaccine. When in 1954 a vaccine for human use efficacy trials that have shown audiences step back, hope will be was developed. A vaccine against disappointing outcomes. Equally the narrative that conveys the story measles was developed in 1957 important to those lessons will painted on a canvas at the world’s after its discovery in 1911. The be an account of how many HIV epicenter. scientific journeys took 47 and 46 study participants, communities, years respectively. The discovery stakeholders, and study teams and introduction of vaccines to remain committed to help end The Science prevent the transmission of other the epidemic and its impact the pathogens is a test of will. The world over. of bnAbs scientific community persevered and their actions embody the When the AMP teams’ scientists words of Helen Keller that take to the podium, more than What is a Broadly “optimism is the faith that leads to 4 years after the study’s first Neutralizing achievement. Nothing can be done infusion, their voices will be Antibody (bnAb)? without hope and confidence.” amplified by the study participants from 11 countries who want to see A bnAb is an antibody that Four decades later, the HIV and an end to HIV. Around the world neutralizes many of different AIDS pandemic continues to people will witness an account of strains of HIV that are found around the world. Antibodies are proteins produced by the immune system’s B cells that can neutralize the virus, blocking it from causing infection. Antibodies can also help eliminate the virus from the body. They are shaped like the letter “Y”.

HIV The good news is that antibodies can prevent infection. The even better news is that they have immunological memory. The first time you are infected by a virus you will develop antibodies against that virus. The next time you come in contact with that same virus, you will already have antibodies prepared to fight against Host Cell that particular virus. This is what Image Credit: Lisa Donohue preventive vaccines try to mimic. Continued on the next page...

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 6 Featured Article What is VRC01? Advancing HIV The AMP Studies Can: VRC01 is a bnAb against HIV. It Vaccine and 1. tell us what the best models stops HIV from binding to human Prevention Efforts are for testing candidate HIV CD4 T-cells by attaching to the vaccines in animals; virus and preventing it from In early HIV vaccine development infecting the T cells. The VRC01 efforts, attempts were made to 2. help determine effective blood antibody is able to bind onto HIV induce neutralizing antibodies, antibody levels that could at the CD4 binding site on the but no HIV vaccines tested thus prevent HIV; gp120 protein, which is the same far have produced neutralizing spot that HIV would ordinarily use antibodies of significance. 3. determine what antibody to attach to CD4 T-cells to infect Naturally occurring bnAbs in levels an HIV vaccine may them. In animal studies, VRC01 individuals living with HIV arise need to elicit to prevent HIV neutralized HIV and prevented rarely, and typically take many infection; and about 90% of the HIV samples that years to develop. However, most were tested from being able to effective licensed vaccines, such 4. make future HIV vaccine attach to T-cells and infect them. as the measles vaccine, induce neutralizing antibody responses, development more efficient and they provide protection from and cost effective. infection via neutralization. The AMP studies are the first efficacy Aziel Gangerdine is the Director of Communications for the HVTN. trials to address the question of whether a broadly neutralizing antibody against HIV could be protective against infection.

7 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Featured Article In Harmony - Transgender People and Early Phase HIV Vaccine Trials By: Aziel Gangerdine, HVTN Core, Seattle, WA, USA Early phase HIV vaccine clinical early phase studies conducted “It is really clear that the trials are designed to assess if between 2009 and 2014. The communities most impacted want an investigational HIV vaccine primary reasons for participation a resolution to a four-decade old is safe and well tolerated in were altruistic for all participants. pandemic [HIV/AIDS],” Andrasik study participants. In addition, pointed out. researchers study if the vaccine Overall, figure 2 confirms that will stimulate the body’s immune transgender and cisgender Statistics from the 2015 US system to make responses against people had similar motivations Transgender Survey (USTS) HIV. Study participants who for participating in early phase reported that “one-third (33%) enroll in the trials must be HIV trials. Participants expressed that of transgender participants seronegative and less vulnerable to the most compelling reasons for experienced at least one negative the transmission of HIV. Knowing participation were to help find an health care experience related this made it necessary for me to effective HIV vaccine, to help their to being transgender.” Verbal meet the first author of a published community, and to be informed harassment and refusal to provide manuscript titled, “A descriptive about HIV research. Transgender treatment because of gender analysis of transgender participants participants were less motivated identity are two reasons noted by in phase 1 -2a trials of the HIV by financial incentives, naming transgender people for why they Vaccine Trials Network (HVTN) in “knowing someone living with actively avoid seeking healthcare. the United States and Peru.” HIV” as a more compelling reason And, in Peru structural factors such to enroll as a participant. as legislation that restricts changes For the layperson, the manuscript Continued on the next page... can deter you from reading – it contains a range of graphs and scientific terms that necessitate a place for the Oxford dictionary in your office, or google.com on “speed click.” Dr. Michele Andrasik is the Director of Social and Behavioral Sciences and Community Engagement for the NIAID-funded HIV Vaccine Trials Network (HVTN), and we met to talk about the manuscript, the result of a cross-protocol study that analyzed data from 694 participants enrolled in six early phase clinical trials conducted by the HVTN.

Andrasik exudes a pleasant disposition and smiled radiantly in a thought-provoking discussion about the importance of early phase HIV vaccine trials in this cross-protocol analysis. The study measured several variables to determine why 681 (98%) cisgender and 13 (2%) transgender study Figure 2: Reasons for enrolling in Phase 1-2a HIV participants enrolled in the HVTN’s Vaccine Trial Network Trials 2009 – 2014

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 8 to gender markers and legal names site staff who were familiar with Data from this cross-protocol on official documents” limits access gender transition and affirmation study provided evidence that to healthcare for transgender procedures, specific health transgender people can not only be individuals. concerns, hormone use, and eligible for trials enrolling people identity documents specifying who are determined to have low In addition, “multilevel social gender identities or legal names are vulnerability to the transmission and structural factors such as all factors that impact the retention of HIV, but they are also able to poverty, discrimination, mental of transgender people and their remain HIV uninfected over the illness, homelessness, abuse, experience as study participants. course of their study participation. distrust of the health care The study team suggests that community, and concerns about “The results, after implementing transgender participants in early disclosing transgender status” data-driven strategies to phase HIV vaccine trials are more make transgender people more create transgender-affirming likely to be in communities where vulnerable to the transmission environments at our clinical there is high HIV incidence. This of HIV. trial sites, are noteworthy,” explains why “I know someone Andrasik beamed. with HIV infection” was cited Knowing the lopsided burden as a reason why transgender that HIV places on transgender Furthermore, the study confirmed participants get involved in communities, and the factors that “transgender participants preventive HIV vaccine trials. that create barriers for transgender reported no negative social impacts Transgender participants also individuals’ participation clinical due to clinical trial participation, demonstrated excellent retention, trials, requires transformation and 93% of transgender as shown by only three missed strategies to create an experience participants identified having visits (2.1%) and no discontinuation where the individual’s interest experienced at least one social of vaccinations across the six and willingness to participate benefit of participation.” protocols included in the analysis. in a clinical trial is met by a transgender-affirming Additionally, researchers wondered Andrasik is adamant, “We must healthcare setting. whether it was plausible to enroll conduct clinical trials that are transgender study participants inclusive. In order to do so we must “We need to continue and enhance in early phase clinical trials. be aware of the factors that make our efforts to create clinical trial When the population has higher some people in our communities environments that are equipped vulnerability, can individuals with more vulnerable to HIV to welcome and affirm our diverse low vulnerability be identified, transmission than others. In many communities who are willing to enrolled, and retained? cases these factors also create enroll and move science forward,” barriers to participation. Whenever stated Andrasik. possible, we should be prepared to mitigate these challenges.” Creating transgender-affirming environments is no easy Aziel Gangerdine is the Director of undertaking. In 2007, the HVTN Communications for the HVTN. took bold steps when it established a Transgender Working Group to “identify and provide input regarding operational and clinical needs related to the inclusion of transgender participants in HVTN trials.” First, the Network adapted its demographics Case Report Forms (CRFs) to collect data on sex assigned at birth and self-identified gender identity – a process known as the two-step method. Secondly, Dr. Michele Andrasik, Director clinical trial staff were trained to of Social and Behavioral Sciences be more culturally responsive to and Community Engagement, transgender participants. Having HIV Vaccine Trials Network

9 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 UPCOMING EVENTS/CONFERENCES/MEETINGS

HIV VACCINE AWARENESS DAY May 18, 2020

ADHERENCE 2020 https://www.iapac.org/conferences/adherence-2020/

2020 IMPAACT ANNUAL MEETING https://impaactnetwork.org/

2020 SAVING OURSELVES SYMPOSIUM https://sosexperience.org/

2020 ACTG ANNUAL MEETING https://actgnetwork.org/

23RD INTERNATIONAL AIDS CONFERENCE (AIDS2020) https://www.aids2020.org/

HIV2020 CONFERENCE https://actgnetwork.org/

2020 US CONFERENCE ON AIDS http://usconferenceonaids.org/

2020 AMERICAN PUBLIC HEALTH ASSOCIATION MEETING https://www.apha.org/events-and-meetings/annual

Editors Note: Many of these meeting dates have changed prior to print, and it is unclear if they will change again. Please use the above links to determine the most accurate dates of the meetings.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 10 Spotlight Responding to a Four-Decade Old Epidemic While Thwarting the “New Kid on the Block”

By: Aziel Gangerdine, HVTN Core, Seattle, WA, USA Pulitzer Prize-nominated author as a result of the necessary State My most recent in-person James Martin astutely stated order. COVID-19 is testing our meeting with Dr. Takalani, fondly that we must “thwart the rapid definition of freedom amongst known as “Azwi,” was at the 2019 spread of infectious diseases that other things. In our homes and International Conference on could kill millions of people.” in the workplace, measures are AIDS and STIs in Africa (ICASA), In 2007, Martin described “The implemented that redefine our held in Kigali, Rwanda. She has 17 Greatest Challenges of the social and economic patterns a booming laugh and a memorable Twenty-First Century,” listing of life. smile to complement her conquering disease as number engaging personality. 10 amongst others such as It seldom rains, reversing poverty, preventing “A lot of children in my community all-out war, defusing terrorism, instead it pours were/are being raised by their and cultivating creativity. The impact of COVID-19 grandparents or elderly aunts and manifested quickly in the HIV uncles after losing their parents to In the US, the state of Washington prevention clinical research HIV/AIDS,” said Azwi, illuminating (where the HVTN’s offices are environment. Known for its pursuit the context in South Africa. located) is under a “stay home, of a safe and globally effective Immediately, I was reminded of the stay safe” order, one of several preventive HIV vaccine, the HIV devastation the four-decade old measures underway to prevent Vaccine Trials Network’s (HVTN) HIV/AIDS epidemic had on families the transmission of a contagious study teams are now facing off and communities in the country. viral infection called Severe Acute with a “new pathogenic kid on the This impact was replicated in many Respiratory Syndrome Coronavirus block,” in addition to conducting communities globally. (SARS-CoV-2), known to cause the clinical trials to help end HIV. I disease COVID-19. If asked, I’d best suspect that Martin would applaud Although I could not enjoy Azwi’s describe Seattle, Washington, as the Network’s efforts to quell the in-person conversation, it was a young dame – breathtaking in potential impact of SARS-CoV-2 clearly evident that her responses natural beauty and kind in socio- at the same trial sites where HIV were saturated with a deep sense economic experience. As can be prevention trials are underway. of concern as we delved into her expected, I regularly enjoy brisk thoughts on the circumstances walks in my neighborhood where “Our study teams are dedicated in South Africa. flora meets concrete and wood in to finding solutions for health the bustling landscape of the city’s problems that have affected our She started to peel back her South Lake Union neighborhood. communities in a profound way,” thoughts about the ripple effects It has been two months and the says Dr. Azwi Takalani, one of set in motion by the “new kid.” sounds of nature are amplified the HVTN’s Regional Medical “The realization that the population in a deafening silence. Liaisons in Johannesburg, group that filled the parenting South Africa. Study teams at gap is also probably the most My recollection of when COVID-19 trial sites were empowered to vulnerable to severe COVID-19 started to reorganize my daily implement measures, aligned illness is an important factor to pattern of life is clouded by my with recommendations from their consider when we re-organize life feeling the need for a silver lining local public health authorities, to as a community during and after every so often, not succumbing to prevent the possible transmission this pandemic.” the confinement of my apartment of SARS-CoV-2. and the sense of suffocation, all

11 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Since it first emerged in late 2019 in China, a significant number of people around the world succumbed to the disease, prompting the World Health Organization to officially declare it a pandemic on March 11, 2020.

“The global picture of the impact of the pandemic is sobering. While a lot of work is ongoing in South Africa toward COVID-19 preparedness, the inherent weaknesses in our health care system and endemic HIV and TB infections are an additional source of concern for South Africa,” Azwi said, summarizing the on-the- ground circumstances and coloring the deep concern I read between the lines of her responses.

The world is mobilized and making every effort to save lives and to prevent the transmission of SARS- CoV-2. On March 23, 2020 the President of the Republic of South Africa ordered a 21-day nationwide lockdown, a period later extended on April 9 for an additional two weeks. The President delivered the executive order altering the lives of all citizens, and the aftermath of the decision started to manifest in communities as the country transitioned to an “essential services only” way of life. Top – Bottom: The Kliptown clinical trial site in Soweto, South Africa Among these essential services, reorganized its clinic to practice physical distancing to minimize study staff at the sites are frontline potential exposures to SARS-CoV-2 in the waiting area, and made responders who have in their resources available such as hand sanitizer to disinfect hands. hands the health and safety of Credit: Tricia Phillip study participants enrolled in HIV prevention clinical trials. They have the responsibility to maintain in the face of a new global protect the families they go home the scientific integrity of each pandemic, while not losing sight to at the end of each working day. study, and at the same time, protect of the charge to respond to a four- I cannot pen in these pages the themselves and the participants decade old epidemic, when both weight of such an emotional from the possible transmission infectious diseases are claiming and mental burden. of SARS-CoV-2. lives and impacting communities. I cannot help but draw inspiration “It is certain that life as we knew Frontline responders are known from their actions. While on duty it has already changed, and will to many as heroes. I am in awe and in service to their communities continue to do so in the near of their courage and the bold and countries, study teams must future,” Azwi concluded. relentlessness they demonstrate take every measure necessary to Continued on the next page...

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 12 Navigating to help, I severely underestimated communications, coordination the complexity of the mission,” she and decision making. The entire Unchartered Waters stated. process is evidently risk prone. to Support our “The demand took a toll on my Frontline Responders According to Yunda, vetting sleep time, family time and business partners became the “normal” work time, but I feel COVID-19 drew new battle lines most important step in a very fortunate that I could help,” she in the sand at each clinical trial complex process involving a “sea shared. site and decisive action was of connections.” Navigating the needed to equip study teams with uncharted waters also meant that Yunda explained that the purchase specialized personal protective she would be in direct competition of N95 masks, for example, is only equipment (PPE) for their daily with governments and large possible when paying cash up showdowns with COVID-19. The medical supply companies, all front, and is considered successful global demand for PPE, largely in need of the same approved only when the item is delivered produced by the People’s Republic PPE, and who, unlike Yunda, and in your hands. Sellers readily of China, increased significantly demonstrated significant accept new offers from buyers if as response efforts gained purchasing power. the profit margin can be doubled, momentum. However, travel and and the generated revenue would export restrictions set in motion A series of reports such as the CBS settle the payment of penalties to curb the spread of SARS-CoV-2 news story on April 13, titled “As incurred for breach of contract led to unintended consequences world turns to China for PPE, U.S. with the first buyer. While your such as restricted shipment of PPE buyers risk knock-offs and price payment could be refunded from items globally. In South Africa, sites gouging,” (https://www.cbsnews. a breach of contract, such an were having difficulty obtaining com/news/china-ppe-us-buyers- incident would delay the shipping the necessary items they needed knock-offs-price-gouging/) timeline, which was scheduled to appropriately protect their staff members. My university professor used to say that there are three kinds of people: those who watch things happen; those who wait for things to happen; and those who make things happen.

Fittingly, I think of Yunda Huang, PhD, Principal Staff Scientist at the Fred Hutchinson’s Statistical Center for HIV/AIDS Research & Prevention (SCHARP), as the latter of the three personalities. A US citizen, responding from her home in Shanghai, China, she described L – R: Kentse Khuto, HVTN Senior Site Liaison Manager with Dr. what it took to equip study teams Azwidhwi Takalani, M.D., HVTN Regional Medical Liaison and in South Africa with much-needed Michelle Nebergall, PhD, HVTN Clinical Trials Manager, pictured personal protective equipment in Johannesburg, South Africa at the delivery of the PPE from China. (PPE). The team arranged the delivery of smaller batches of PPE to each site.

Yunda is the lead statistician on Credit: Kaelin Ragavan, Operations Manager, Biocair other “normal” HVTN projects, and worked to obtain the PPE while confirmed the race to locate and based on the purchase agreement carrying out her research duties. procure the coveted PPE, ultimately before the seller opted to cancel “Procuring PPE in such a political increasing the demand even more. because of a more lucrative sale. and epidemiological climate was simply a non-existent type of job I tried to imagine the moments of “Just for one shipment, I had to before this pandemic. Although I unrelenting pressure Yunda must use a lot of free consultation time felt a tremendous responsibility have endured while managing all from my lawyer friend to help me

13 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 comb through 11 legal agreements who support and stand alongside to make sure the purchase was her as she steps forward to carry legitimate, protected our rights the baton to help end HIV and and funds, and ultimately made now, to curb COVID-19. To Yunda, the delivery of about 10 different her children are an inspiration types of PPE items possible,” Yunda and strength reminding her that described, as she reflected on her efforts over many hours are the important details needed changing the lives of people. to mitigate the potential risks to the HVTN. Globally, COVID-19 continues to test more than just the strength All of this was further complicated of economies, the resilience by international travel restrictions of healthcare systems, our and the ever-changing export definition of freedom, and the policies in China. Every delay going concerns of businesses – to planned shipping schedules it is testing our humanity and inevitably derailed all of the Dr. Azwidhwi Takalani pictured benevolence. History is being anticipated delivery of the PPE with her two children / Photo written with these unrelenting items to the research sites. supplied by Azwidhwi Takalani efforts to face life threatening Eventually, the clouds did part adversaries such as HIV/AIDS and and a silver lining appeared. Azwi is mother to two beautiful and COVID-19. We call each adversary bubbly toddlers, one who believes by name and we recognize the “It took only three weeks between that her mother can transport impact of each. We also recognize the moment the mission was the African big five [lion, leopard, what these adversaries do not ‘assigned’ and the moment that rhinoceros, elephant, and water have – our will and human spirit first-rate PPE was safely delivered buffalo] on an aircraft. I recollect to overcome, as well as the need in South Africa from China. If that a video call of Azwi making such to protect future generations who is not a miracle, what is?” a promise while we were in Kigali. are the spirit behind our struggle Yunda said. In the eyes of the young toddler, and the wind beneath our wings. she believes her mother can do Aziel Gangerdine is the Director of Witnesses to the what few people can. Communications for the HVTN. Extraordinary, and What Motivates Our Heroes

COVID-19 is the new pathogenic kid on the block, and is proving to be a formidable adversary by forcing the hands of decision makers to exercise what some deem to be draconian measures in order to save lives.

Amidst the uncertainty of the near future and the disheartening circumstances we are faced with at home, in our communities, in the workplace, and in our countries, I Yunda Huang, PhD, flanked think about what it is that gives our by her two children / Photo heroes at the frontlines like Azwi, supplied by Yunda and the brave yet often unseen heroes like Yunda, and many other In Shanghai, 15 hours ahead of individuals the support they need Seattle, the wind under Yunda’s to do what they are called on to do. wings can be seen in her children

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 14 Featured Article Facing Down Pandemics: Dr. Larry Corey on HIV and COVID-19

By: Sabin Russell, Fred Hutch News Service, Seattle, WA, USA

When Dr. Larry Corey first heard reports of a respiratory virus spreading rapidly in Wuhan, China, the renowned virologist and former President and Director of Fred Hutchinson Cancer Research Center felt that unsettling sense of déjà vu.

“As you saw the devastation that it was causing in Wuhan, and you understood the transportation patterns and the people flow in China, you started to understand the implications,” said Corey, during a recent interview for HVTN Community Compass.

“In many respects, COVID-19’s a re-living of what happened 39 Dr. Larry Corey, Principal Investigator, HVTN, Seattle, WA, USA years ago in HIV, when it was difficult and frustrating,” he said. Photo Credit: Matt Hagen “The lesson that we learned then is that when the academic, biotech Yet that tiny virus quickly In 1998, at the urging of National and pharmaceutical communities transformed the trajectory of Institute of Allergy and Infectious put their collective scientific assets Corey’s career. The deep ties he Diseases director Dr. Tony Fauci, together, things happen.” had developed with the community Corey co-founded the HIV Vaccine as a researcher in sexually Trials Network, headquartered at In June 1981, as a University of transmitted diseases propelled him Fred Hutch. One of the first people Washington researcher then into a leadership role in fighting he hired was Steve Wakefield, who working on a treatment for genital stigma, bigotry and fear. As the today leads HVTN’s global efforts herpes, Corey read in the Centers world struggled to understand HIV, for stakeholder engagement. for Disease Control’s weekly he rose to become an authoritative newsletter a brief report of five voice on how to treat it with “Larry has a deep moral conviction cases of gay men in Los Angeles antiviral drugs. to take care of the world that he’s felled by Pneumocystis carinii, a in with the talents that he has,” rare pneumonia previously found As chairman of the AIDS Clinical Wakefield told Fred Hutch writer in people with compromised Trials Group, he shuttled from Mary Engel. “But he didn’t get any immune systems. Seattle to Washington D.C. recognition for the sacrifices he’s to oversee critical trials, first made to solve this epidemic. Until It would be another two years before proving that AZT could protect he had his grandchildren, I never the Pasteur Institute’s Drs. Francoise newborns of HIV-positive mothers, remember him going on vacations. Barre-Sinoussi and Luc Montagnier then launching the trials on Now, part of his drive to find a isolated the retrovirus later proven combination therapies that have vaccine is so his grandchildren to be the cause of it, and still years since saved millions of lives. Then will never have to live with HIV.” before the global impact of HIV his focused shifted to vaccines. would be fully comprehended.

15 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Over decades, the tireless infusions of broadly neutralizing COVID-19 reached Seattle, its quest for an HIV/AIDS vaccine antibodies were given to volunteers. first significant toehold in North has weathered a string of One other HVTN trial, Imbokodo, America, researchers at Fred Hutch, disappointments. The vaccines is fully enrolled with ongoing UW and Public Health-King County tested in carefully designed clinical follow-up underway, and a related & Seattle, responded decisively trials have so far failed, but as trial, Mosaico, was just getting because of the deep understanding the body of knowledge about the underway when COVID-19 struck. of virology and the infrastructure immune system continues to of laboratories and expertise that expand, Corey remains cautiously, “Altruism and concern about Corey had built over four decades but steadfastly, optimistic. HIV are alive and well, and you of confronting HIV. certainly see it in the MSM and In early February, he had to deliver transgender communities in “I came to this city that I love the news that the Uhambo trial, the U.S. and South America, and 42 years ago as a UW faculty HVTN 702, showed no efficacy and among the people of southern member to start a virology was shutting down. The hope had Africa,” he said. division. I inherited a program been that this vaccine regimen in a small lab in the basement of would improve upon an earlier Yet the impact of COVID-19 was Children’s Hospital,” he recalled. version found modestly effective coming quickly, even to South “And we built it into the largest in a large trial in Thailand in 2009. Africa. Corey had to cut his trip academically based virology lab Instead, it showed no effectiveness short and return to Seattle, where in the country. Then of course we at all. he is coordinating multiple efforts set up the Vaccine and Infectious with Fred Hutch, the University Disease Division at Fred Hutch, “You did a damn good job,” he told a of Washington (UW), the Bill & and between UW and the Hutch, gathering of staffers at Fred Hutch. Melinda Gates Foundation, and I believe it’s the largest faculty in “It was a painful answer, but our job other community partners to infectious diseases in the country.” is to do these studies, and you did it respond to the latest threat. incredibly well.” “We trained an enormous number Cruelly underscoring the of people in viral disease. So, Later that month, Corey met with interconnectedness of the struggle it is gratifying to see how that his South African counterparts and against pandemic viruses, the infrastructure presented Seattle the disappointed participants in HVTN community learned in with the opportunity to handle this Cape Town to thank them for their March that Dr. Gita Ramjee died new epidemic. It allowed us to do courage and to assure them that of COVID-19 in March, soon after COVID-19 testing at a rate better the quest will go on. returning to Durban, South Africa, than essentially any other city, and from a visit with her sons in that has been an incredible factor “One trial of five failed, but we still London. She was 63. in our response.” have four more out in the field,” he said in his recent interview. “It is so sad when you see so Sabin Russell is a writer and editor “There is sadness, but science many deaths happening. When a for the Fred Hutch News. is about resilience. You have to colleague passes away prematurely, have optimism, resilience and it’s a loss in our family, but also for perseverance.” the world,” Corey said.

By year-end, Corey anticipates With a new pandemic underway, results from the recently completed he once again stands in the Antibody Mediated Prevention, or forefront of scientific efforts AMP, studies, where over 40,000 to stop a global threat. When

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 16 Featured Article The HVTN and HPTN Remember Gita Ramjee

women’s lives. I dedicated my time many of the National Institutes of to researching methods of HIV Allergy and Infectious Diseases and prevention.” – Dr. Gita Ramjee the Division of AIDS’ HIV prevention networks clinical trials, ranging Gita pursued this mission up to from early phase studies to late her sudden passing, as a critical phase efficacy trials. She contributed investigator for the HVTN to our understanding of the role of and HPTN. topical and systemic products in HIV prevention, and more recently, made “We are deeply saddened that Dr. a notable contribution to the active Gita Ramjee passed away due and passive immunization programs to a COVID-19 infection,” said in the HVTN and HPTN. Dr. Larry Corey HVTN principal investigator (PI). “She will be sorely missed by generations of HIV prevention Gita spent the past 18 years of her scientists,” said Dr. Wafaa El-Sadr, career as the director and chief HPTN co-PI and director of ICAP at Columbia University in New Gita Ramjee, PhD specialist scientist of the HIV Prevention Research Unit, South York. “Gita’s energy and dynamism Gita Ramjee, PhD, renowned African Medical Research Council were incomparable. Her steadfast for her extensive work on HIV (SAMRC). She was also an honorary commitment to the quest for prevention and a valued colleague professor in the Department of effective HIV prevention methods to so many in the HIV Vaccine and Epidemiology and Population and women’s health will continue Prevention Trials Networks (HVTN Health, London School of Hygiene to motivate all of us who had the and HPTN), sadly succumbed and Tropical Medicine, and opportunity to know her and work to complications associated a clinical professor in the with her”. with SARS-CoV-2 infection. Department of Global Health, School of Public Health, University “Gita was a wonderful colleague Gita started her career in science of Washington, Seattle. and friend who made critical after receiving her PhD at the contributions to HIV prevention University of Sunderland in the “She left a lasting imprint on HIV throughout her long and United Kingdom (UK). Her scientific prevention research and the HVTN distinguished career; she will be work centered in South Africa early through her dedication, critical greatly missed,” said Dr. Myron S. in the epidemic where she led a thinking and lasting commitment to Cohen, HPTN co-PI and director of project on vaginal microbicides our collaborative group of scientists,” the Institute for Global Health and for the prevention of HIV among a said Dr. Glenda Gray HVTN co- Infectious Diseases at the University group of sex workers working along PI and President and CEO of the of North Carolina at Chapel Hill. the trucking route between the port SAMRC. “She was an incredibly city of Durban and the commercial committed colleague to the cause Our thoughts and prayers go out to capital in Johannesburg. of reducing the impact of HIV her family and all her friends and on South African society.” colleagues who worked with her As she noted when she received throughout these years. Her sudden the European “Outstanding Female In her leadership role, she trained passing will be a significant loss to Scientist” Award by the European and mentored numerous cohorts of our organizations and an even larger Development Clinical Trials scientists and clinical trial staff, who hole in our hearts. Partnerships for her work on finding now populate the network of trial new HIV prevention methods. sites in South Africa and beyond. We carry you in our memories, Gita, They will carry her legacy forward “I learned about the dire need for for many years. Drs. Larry Corey, Glenda Gray, women-initiated HIV prevention Myron S. Cohen, Wafaa El-Sadr, options and the socio-behavioral Gita was a study principal and Jim Kublin and cultural factors that impact investigator and unit director for

17 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Featured Article Phase 1 Broadly Neutralizing Antibody Efforts By: Dr. Shelly Karuna, HVTN Core, Seattle, Washington, USA

Broadly neutralizing antibodies (bnAbs) have the potential to greatly contribute to global HIV prevention, treatment and cure efforts. These antibodies are naturally developed by the immune systems of some people living with HIV, though usually the virus evolves faster than the immune system’s antibody response. When HIV outpaces the development of these special antibodies, they may be unable to prevent, fully suppress, or eradicate the virus in the body of the person who made them. However, scientists can identify these bnAbs and make copies of them in a lab. Sometimes, scientists can also make small changes to these antibodies to improve their potential ability to prevent, treat, or cure HIV. Image Credit: Lisa Donohue

Antibodies are shaped a little Figure 1. Neutralization function of an antibody against HIV. like the letter Y, with two “arms” Figure 4 in Karuna & Corey, Annu Rev Med, 2020. and a “foot.” Antibodies work to fight HIV in two primary ways. the CD4 binding site, the V2 in blood and in mucosal tissues. First is neutralization, in which loop, the V3 glycan region, the Pharmacokinetics (PK for short) the “fingertips” of the antibody membrane-proximal external describe how the antibodies bind to the HIV envelope protein region (MPER), and others (see travel in the body, and how much (gp140, or Env) and prevent it Figures 3-4). They can also work antibody is in the body over time. from binding to and infecting with other immune cells like NK target cells like healthy T-cells cells or dendritic cells in different In 2015, using information from (see Figure 1). Second is through ways. This is comparable to how the earlier trials, the HVTN, HPTN, Fc-effector functions, in which different antiretroviral drugs Vaccine Research Center (VRC), the “foot” portion of an antibody (ARVs) attack HIV at different and DAIDS began collaborating recruits other healthy immune places and in different ways. on the world’s first two bnAb HIV cells, like natural killer (NK) cells or prevention efficacy trials—the macrophages, to help kill or remove Since 2014, the HVTN has Antibody Mediated Prevention HIV from the body (see Figure 2). collaborated with many partners (AMP) studies (HVTN 704/HPTN BnAbs are special because they can on the development and 085 and HVTN 703/HPTN 081). do these functions for many of the implementation of a portfolio of The AMP Study results are different strains or types of HIV studies to evaluate the potential anticipated in late 2020, and the found around the world, whereas of several different bnAbs against trials are designed to teach us more common antibodies, those HIV. These studies began with the whether the VRC01 bnAb can that are not broadly neutralizing, HVTN 104 and HVTN 116 studies, prevent HIV infection, and if usually only recognize some which evaluated VRC01 and/ so, what concentration of VRC01 viruses from one or a few strains or the longer-acting VRC01LS in the blood is required for of HIV. Different bnAbs can bind to bnAbs, demonstrating their safety that protection. several different parts (“epitopes”) and providing more information of the HIV Env protein, including about their pharmacokinetics Continued on the next page...

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 18 Since AMP opened in early 2016 to Medical Center (BIDMC) and Glossary evaluate VRC01, which attaches to the International AIDS Vaccine the CD4 binding site, we have seen Initiative (IAVI) to advance these Bioavailability is the proportion several other bnAbs enter clinical bnAb products into DAIDS- of a drug or other substance trials, including: sponsored clinical trials, and which enters the circulation when we have designed these trials to • additional VRC01-class antibodies introduced into the body, and so explore many research questions with changes made to help them is able to have an active effect. (e.g., dose, administration route, last longer in the body (e.g., timing between infusions) to VRC01LS, VRC07-523LS); Pharmacokinetics (PK) describe inform the next bnAb efficacy how the antibody moves through • several antibodies that bind trial. We are now primarily looking the body and tissues, and how to other HIV Env epitopes at combinations of bnAbs to the body processes the antibody including the MPER (e.g., 10E8 determine the safety of using over time. and variants), V2 loop (e.g., them together. We think that PGDM1400), and V3 glycan using combinations of bnAbs that region (e.g., PGT121 and 10-1074); attach to different parts of HIV see( The first post-AMP phase 1 trial • and antibodies with multiple Figure 3-4) could lead to greater in the bnAb portfolio, HVTN127/ specificities, meaning that one efficacy, both for prevention and HPTN 087, explores a range of antibody can attach to several for treatment, similar to how we doses and routes of administration, places (e.g., trispecific bnAbs need to use combinations of ARVs including the first evaluation like SAR441236). to effectively prevent and treat of intramuscular (IM) bnAb HIV infection. These phase 1 trials administration in our field. It The HVTN and HPTN are will also provide lessons crucial tests the potent CD4 binding site collaborating with the National for the smooth implementation of antibody, VRC07-523LS, which we Institute of Allergy and Infectious the next efficacy trial, as HVTN 104 think will be an anchor for a next- Disease’s Vaccine Research did for AMP. See Tables 1 & 2 for generation bnAb combination. Center (VRC), Sanofi, Rockefeller, a summary of the current phase 1 This trial not only builds a robust CAPRISA, Beth Israel Deaconess bnAb portfolio. safety database for VRC07-523LS,

Table 1. Network bnAb trials fully enrolled.

Table 2. Network bnAb trials enrolling and in development. Note that timelines are anticipated to shift due to the COVID-19 pandemic. (*AE in FIH means adverse event in first in human study)

19 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Image Credit: Lisa Donohue

Figure 2. Fc-effector function of an antibody against HIV. Figure 5 in Karuna & Corey, Annu Rev Med, 2020. but it also allows us to compare greatly simplify manufacturing, by VRC07-523LS. The triple bioavailability, neutralization, regulatory, operational, and combination adds PGDM1400 and and PK profiles across IV, SC, other potential challenges of the V3-binding bnAb PGT121. One and IM administration routes in administration compared to using of the 2-bnAb combinations uses preparation for future trials. a combination of separate bnAbs. the V2-binding bnAb PGDM1400 This trial, together with HVTN with VRC07-523LS. The remaining HVTN 128 supplements HVTN 127/ 130/HPTN 089, HVTN 136/HPTN 2-bnAb combinations use different HPTN 087 with data regarding 092, and others will explore the V3 glycan binding bnAbs (10-1074 mucosal concentrations of potential neutralization effects and PGT121 or its long-acting VRC07-523LS. This trial includes of bnAb combinations, including version, PGT121.414.LS) with vaginal, rectal, and semen sample whether the combinations might VRC07-523LS. This will allow for collections and builds upon the result in the antibodies working a comparison of any differences HVTN’s extensive bnAb/mucosal against each other, helping each in how the different V3 bnAbs sampling experience in HVTN 104 other, or building on each other. contribute to neutralization when and HVTN 116. As HVTN 129/HPTN 088 builds paired with VRC07-523LS. One the first-in-humans safety, PK, of the key concepts these trials HVTN 129/HPTN 088 will truly and neutralization profile of a will explore is whether the site be a vanguard trial, exploring multi-specific product for HIV of action (where the bnAb attaches the potential for a single bnAb prevention, it will also inform to HIV) influences the eutralization that binds to three different further bi- and trispecific bnAb activity in the body, and whether HIV Env sites or epitopes. This development work being done this activity is similar when manufactured “trispecific” bnAb by several groups in the HIV different combinations or from Sanofi includes elements bnAb field. binding sites are used. from other bnAbs: binding to V2 from PGDM1400, binding to HVTN 130/HPTN 089 and HVTN HVTN 138/HPTN 098 also evaluates MPER from 10E8, and binding to 136/HPTN 092 are, in many a dual combination of VRC07- the CD4 binding site from VRC01. ways, partners to the trispecific 523LS with a V2-binding bnAb, We think this will provide greater trial, as they evaluate triple and CAP256V2LS, that is particularly breadth and potency than any dual combinations of bnAbs potent against Clade C HIV. The single bnAb that has only one administered separately. All of bnAb on which CAP256V2LS epitope specificity. It may also the combinations are anchored Continued on the next page...

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 20 Image Credit: Lisa Donohue Figure 3. Potential binding sites for bnAbs. is based was identified from us toward a goal the HVTN has routes, such as SC injection vs. a participant in a trial at the held for two decades—to expand infusion pump, or even wearable Centre for the AIDS Programme the HIV prevention toolbox and, SC injectable devices. Changes to of Research in South Africa in particular, to achieve a safe the Fc or “foot” portion of the bnAbs (CAPRISA). The bnAb was then and effective HIV vaccine as may help bnAbs last longer in the developed and manufactured efficiently as possible, an effort body (e.g., the LS modification) by the VRC. Clade C is the major the bnAb portfolio informs and or may help bnAbs work better strain of HIV that causes infection thus advances. with immune cells to add to in South Africa, and this study is neutralization for improved HIV planned for South Africa, as well Yet much work remains. Optimal prevention, treatment and possibly as the US. bnAb combinations—and the cure. Additional mucosal studies effects of combining bnAbs may help us better understand The identification and optimization in a multi-specific design or how these antibodies get into of bnAbs against HIV have separately—must be further different mucosal tissues and helped scientists learn more explored. Subcutaneous how they function. And perhaps about the structure of HIV and (SC) administration must be most importantly, a marker such its vulnerabilities, which helps improved, such as making higher as antibody concentration in the target and expedite efforts to concentrations of the antibodies blood could support more efficient develop an HIV vaccine. The efforts to allow a lower volume to be given, advancement of bnAbs and HIV described here are advancing and testing different SC doses and vaccines for future efficacy testing.

Image Credit: Lisa Donohue Many of these advances are possible starting with the suite of Network antibody trials described here, and moving forward with the next generations of bnAbs, to bring bnAbs for HIV prevention— and a preventive HIV vaccine—to communities throughout the world Dr. Shelly Karuna is the Director of Figure 4. Another view of potential binding sites for bnabs. Clinical Development at the HVTN. Editor’s Note: The research described in this article has been published: Karuna, S. T., & Corey, L. (2020). Broadly Neutralizing Antibodies for HIV Prevention. Annual Review of Medicine, 71, 329-346.

21 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 HVTN Core Update New SBS-CEU Staff at HVTN Core Luciana Kamel joined the HVTN and her first day was December 11th. Luciana is the newest Community Engagement Project Manager who is based in Rio de Janeiro, Brazil. As the newest member of the Social and Behavioral Sciences and Community Engagement Unit, Luciana will be primarily focused on implementing the HVTN Community Engagement program in Argentina and Brazil for the Mosaico Study (HVTN 706/ HPX3002).

Luciana joins our team with a wealth of experience in community engagement in clinical research environments and health education. She was previously at the Fiocruz CRS in Rio as the Community Engagement Manager, and has extensive experience engaging MSM and transgender communities in health education and research. She’s earned Bachelor of Arts degrees in psychology and law from Universidade Federal do Rio de Janeiro, Brazil in 2000 and 2013, respectively, and a Master of Arts degree in psychosociology also from Universidade Federal do Rio de Janeiro, Brazil in 2005. She is excited to join the team in this capacity.

Luciana can be reached via email at: [email protected].

Luciana Kamel, MA

For more information about the Mosaico Study’s community engagement efforts, please reach out to Stephaun Wallace, PhD, HVTN Social and Behavioral Sciences Junior Investigator Liaison via email at: [email protected].

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 22 Antibodies help to prevent infection. Most vaccines cause the body to make antibodies. If you get an HIV vaccine, your body may make antibodies to HIV. However, standard HIV tests search for HIV antibodies, a sign of HIV infection for people who have not previously received an HIV vaccine. If you get a standard HIV test after receiving an HIV vaccine, your HIV test results could come back positive even if you are not infected with HIV. This is called a VISP (Vaccine-Induced Seropositive) test result. To avoid this confusion, our study sites use different kinds of HIV tests that look for the virus itself, not antibodies. FREQUENTLY ASKED QUESTIONS ABOUT VISP

Where can I get the right test for HIV? What is “opt-out” testing for HIV? How can I explain this situation to my healthcare provider? You can get the right HIV test at the “Opt-out” testing for HIV means that study site for free. After you leave the HIV tests may be done routinely unless No one can force you to have an HIV study you can continue to go to your a patient refuses to have the testing test for any reason. study site to request HIV testing. If you done. For more information on the • If anyone asks to test you for HIV are no longer located near your study Center for Disease Control’s (CDC) or to draw your blood, tell them site, the HVTN VISP Testing Service can recommendations for HIV testing you are in (or have been in) an HIV help you get HIV testing in your area. in the U.S., please visit: vaccine study and that you need The testing is free. http://www.cdc.gov/mmwr/preview/ to get all your HIV tests at the mmwrhtml/rr5514a1.htm. Getting the right test will prevent study site. an incorrect diagnosis of HIV. For (U.S.) state-specific information, • Explain that being tested outside Your study site or the VISP Testing please visit: of your study site or the HVTN Service can provide the right test. http://www.nccc.ucsf.edu/consultation_ VISP Testing Service could result library/state_hiv_testing_laws/ in an incorrect diagnosis For other information about HIV testing of HIV infection. guidelines in your country, please visit: • Give the provider your study http://www.who.int/hiv/pub/national_ coordinator’s contact information. guidelines/en/ Ask the provider to call the study site or the HVTN VISP Testing Service directly (U.S. toll free: 1-800-327-2932).

• If you have to, simply say “no” to the HIV test, and then ask the study site or the HIV Vaccine Trials Network to help. We are happy to work with you to resolve your situation.

How long does VISP last?

What does “opt-out” testing If you have tested VISP, the antibodies mean for me? may fade quickly or they may last for several years. In some cases, Why don’t standard HIV tests look You should tell your healthcare participants continue to test VISP for actual HIV? provider about your HIV vaccine study for more than 20 years. Standard HIV tests that look for participation and refuse HIV testing. antibodies are quick, reliable and Even if your healthcare provider does affordable. Tests that look for the virus not mention the HIV test, be sure are expensive and not commonly to tell them that you do not want used for an initial diagnosis. an HIV test because you are (or were) an HIV vaccine study participant.

23 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Can VISP be passed from one • If you are planning to apply for Am I eligible for the HVTN person to another? insurance, employment, or the VISP Testing Service? military, please inform your study • In most cases, no. If you have tested YES: site right away. The insurance VISP you cannot pass the antibodies company, employer, or military • If you participated in an HIV to another person by kissing agency may not accept HIV test Vaccine Trials Network (HVTN), or through sexual contact. results from the HVTN. However, AIDS Vaccine Evaluation Group • If you are pregnant, we think there the HVTN can work with them to (AVEG), or HIV Network for may be a chance that you could pass ensure the right test is done that will Prevention Trials (HIVNET) HIV the vaccine antibodies to your baby. show your true HIV status. preventive vaccine study, AND Although this has not been shown What happens if I move far away from • If you received an HIV vaccine*, to happen with HIV study vaccines, the study site where I participated in an AND we know that this happens with HIV vaccine study? other vaccines, like the tetanus • You are willing to provide consent vaccine. Vaccine antibodies that For U.S. participants, call the HVTN to have your blood drawn and for mothers pass to their babies are VISP Testing Service at 1-800-327-2932 HIV testing. temporary and go away over time, during business hours, Pacific Time. NO: and they are not harmful to the For participants outside the U.S., call baby. The HVTN can arrange for your study site and they can assist you • If you have a confirmed HIV you and your baby to have accurate with testing for HIV. If you are unable to infection, OR HIV testing for free for as long reach someone at your study site, send • If you are currently enrolled in an as it is needed. an email to vtn.core.vispcounselor@ HIV Vaccine Trial,** OR hvtn.org to request testing. • In order to donate blood or organs, • As a former study participant, you the donation site will screen you The HVTN VISP Testing Service received a placebo. using an HIV antibody test. If you provides HIV testing for participants test positive for HIV antibodies who have received a study HIV vaccine * If you are not sure if you received an you may be unable to donate an in a National Institutes of Allergy and HIV vaccine, call the HVTN VISP Testing organ. You may also be permanently Infectious Diseases (NIAID) Division of Service (1-800-327-2932). banned from blood donation AIDS (DAIDS)-funded HIV preventive **If you are currently enrolled in an HIV even though you are not vaccine trial and who are no longer able vaccine trial, your testing is provided infected with HIV. to be tested at their study site. by your trial site. If for some reason you How will a VISP test result affect me? Will my information be confidential? are unable to be tested at your site, you can contact your study site or the HVTN • If someone believes you are Yes. All of your information will be VISP Testing Service (US toll free: infected with HIV, you could stored in a limited-access, password- 1-800-327-2932). face discrimination and/or other protected, secure computer database. problems. For example, you could Access to your information will be What if I live outside the U.S.? have problems with medical or limited to the HVTN VISP counselors. Will I have access to the HVTN dental care, employment, insurance, No identifying information concerning VISP Testing Service? a visa for traveling, or entry into the the testing will be released to any third The HVTN VISP Testing Service is open military. You might not be allowed party without your written approval, in the United States. Expansion of the to donate blood or other organs. If except when required by law. testing service in southern Africa is you are pregnant, you may have How long does the HVTN VISP Testing underway. For locations outside of the to explain your situation to avoid Service take to provide test results? U.S., please contact your study site or receiving any HIV treatment during email [email protected] your pregnancy or labor/delivery. Approximately 2 weeks. to request testing.

For more information about getting the right test for HIV

Contact your study coordinator at the HIV vaccine study site or the HVTN VISP Testing Service at (US toll free) 1-800-327-2932.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 24 Site Update World AIDS Day Commemoration Event Report December 2019 Hosted By Synexus By: Lucky Molefe, Synexus Clinical Research Site, Mamelodi East, South Africa

“WE WANT THE WORLD TO FOCUS ON CHILDREN WHOSE LIVES HAVE BEEN DEVASTATED BY AIDS. THE MILLIONS OF CHILDREN WHO ARE MISSING THEIR PARENTS, THEIR CHILDHOOD, THEIR FUTURE, BUT MOST IMPORTANTLY, THEY ARE MISSING YOU. EVERYONE CAN MAKE A REAL DIFFERENCE. YOUR VOICE IS NEEDED IN A GLOBAL MOVEMENT THAT CAN CHANGE THEIR WORLD.” – Pierce Brosnan, actor

Synexus hosted an annual world AIDS day event on the 6th of December at Stanza Bopape Community clinic in Mamelodi East. World AIDS Day is commemorated on the 1st of December globally to bring awareness to the disease that effects millions of people across the world. We once again pulled together members of the community, young and old, under this year’s theme ‘communities unite against HIV’. The day was Launch of Colours Walk Run December 2019 divided into two parts: the colour walk, and speeches that included the traditional candle lighting ceremony. Part One: 5km Colour Walk

All registered participants gathered Colour Run Explosion and start Keeping Walking, December 2019 at the starting point for the of Fun Walk, December 2019 colour explosion that kicked off with the colour walk through the community of Ext 5. CAB members Lesego and Milton coordinated the proceedings for the walk, and marshals that included young high school students from Loxion Science were placed along the route to distribute water and End of Fun Walk, December 2019 Returning from Fun Walk, splash powder paints to those December 2019 participating in the walk.

Community members pose, December 2019

25 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Part 2: Speeches The candle lighting ceremony was led by our CAB chairperson, Part two of the programme was who is also a TAC representative kick-started by our electrifying in Mamelodi, who gave a brief Master of Ceremonies Collen explanation on the significance Khoza, and a prayer session by Mrs. of lighting the candles, saying Agnes Sepeng (CAB member), with that candle lighting is about the Mamelodi Gospel group taking remembering those who have our crowd through a spiritual lost their lives to AIDS and those journey with popular gospel songs. Dr. Sheena Kotze, HVTN 705 affected by the scourge of HIV. Principal Investigator, educating Before candles were lit, a prayer on HIV Prevention Methods and session commenced and after Research, December 2019 the lighting of the candles, a moment of silence took place. The community members were advised not to blow out their candle when extinguishing them, but to use their hands in order to feel the pain that HIV is causing in our society. Master of Ceremonies updating Continued on the next page... the Programme, December 2019

CAB chairperson speaking on role of community in research, December 2019

by ill-informed people. Research is important for communities because it improves quality of life. The chairperson encouraged community members to come forth to the CAB or Synexus staff to Mamelodi Youth Choir –Singing clarify any information that might “Klap and Tap,” December 2019 be misunderstood.

Present at the event was Dr. The motivation by a person living Candle Lighting, December 2019 Sheena Kotze (HVTN Principal with HIV from Treatment Action Investigator) who gave a talk about Campaign (TAC) really touched the importance of not stigmatizing community members’ moods in a people living with HIV using the positive way. The speaker danced placard “Hate the disease not the to a popular song called Amapiano diseased.” Dr. Kotze also touched to demonstrate that people living on the role of HIV vaccine research, with HIV are enjoying life like any and emphasis was put on the other person. importance of ongoing research to prevent HIV and finding alternative preventive methods to complement what is currently available. The Community Advisory Board (CAB) chairperson emphasised the importance of research, and appealed to community members to embrace Motivational Speaker showing research instead of subscribing dance moves, December 2019 to negative statements reported Candle lighting, December 2019

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 26 There was a message of support from local leaders who encouraged people to support Synexus research programmes, and to come forward with questions for clarity. A follow-up speaker promoted the community projects that support the elderly people in Mamelodi, and encouraged other elderly to join senior citizens clubs in order to access support in times of need. The benefit of joining senior citizens gym clubs include staying healthy and being able to receive professional and peer counselling in resolving personal issues around Community leader message of support, December 2019 family matters.

The event was full of entertaining activities from dance, singing, and thoughtful words of wisdom. The Stanza Development centre was able to update and register youth who are looking for skills and jobs opportunities.

There were 197 registered people in attendance. More community members came after registration closed, which means more people were actually present.

The Synexus staff and CAB members were instrumental in Community members confirming support for HIV prevention making the event a success in various ways from community mobilisation, planning, catering and task allocation. We wish to thank Stanza Development Centre, Lulaway, Loxion Science, the CAB and all the other stakeholders in ensuring that community members attended the event as expected despite the forecast for rain.

Lucky Molefe is the Community Engagement Manager of the Synexus Clinical Research Site.

Personality Dancers entertaining community members, December 2019

27 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Site Update Setshaba Research Centre World AIDS Day Commemoration 2019 By: Kagiso Mothwa, Setshaba Clinical Research Site, Pretoria, South Africa Theme: “Know your Status”

For Setshaba Research Centre’s (SRC) World AIDS Day commemoration event, this year we took a twist on the norm. The event promoted SRC’s visibility to the public and surrounding areas within a 3km radius to the site. A Fun Walk from the surrounding areas to SRC was organized to attract not only the community, but also show communities that we are in this fight together, standing to say “Together We Can.”

Our first WAD commemoration walkers in action, with CAB, SRC Staff, Community Members & Stakeholders

Participants of the commemoration included site staff, our CAB, members of the general community, and stakeholders including SAPS volunteers, SANCA, Tshwane Multi-sectoral AIDS Unit, Facility Clinic representatives and other neighboring NGOs. What was even more interesting was that each organization was given a platform to exhibit services they provide to community members.

SRC Staff choir braced us with awesome spirit-lifting songs during the programme.

The purpose of the event was to increase global and local efforts in the prevention of HIV & AIDS by encouraging people to test so that they know their status, and to raise awareness and remind the world that barriers to HIV testing still do exist and that more effort must be given to pulling down these barriers. Lastly, we wanted to promote healthy living and lifestyles amongst our communities. Continued on the next page...

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 28 Dr. Khatija Ahmed (SRC CEO) gave opening Ross Malamatsho (SRC CLO) presenting the purpose remarks during the WAD event programme. of the day to members present at the event.

The walk made so much impact based on the positive feedback received from community members, including an inclusive invite from South African Democratic Teacher’s Union (SADTU) – Tshwane West District, who held a similar event and requested SRC to present a message of awareness and ways we can collaborate toward alleviating this pandemic. For a long time community members within our surrounding area have seen the majority of the staff onsite, but this time it was really a highlight to notice that the walkers included staff reaching out to them. This strengthened our contributions toward combating the HIV/AIDS epidemic, and to also show the affected community that SRC staff members also care.

Kagiso Mothwa is the Community Liaison Officer for the Soshanguve CRS.

Candle lighting in commemoration of all who are We will keep our little lights burning, as part of infected and affected by this epidemic. combating to win the HIV/AIDS battle.

Our very own CAB member Dr. Mookho Malaheha and SRC A beautiful day was sealed with keeping us rejuvenated, staff gave closing remarks on a good dance from our invited pledging support. the journey toward combating guests and staff. the HIV epidemic.

29 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 SIte Update Updates at Vanderbilt CRS One of Our Own at Vanderbilt This year the Rev. Edwin C. Sanders Vanderbilt CRS Welcomes CRS Gets Recognized II Service Award was awarded New Team Member to Dwayne Jenkins, Director of CAB chair Alberta Hardison MyHouse Nashville. Thank you, received the 2019 Brother’s And Dwayne, for your outstanding Sister’s United (BASU) Legacy support and contributions in Award. Alberta has dedicated over ending the epidemic! We couldn’t 10 years of volunteer service and have found a more deserving support to Nashville Black Pride. person to honor this year. The award was presented at our World AIDS Day event, which featured Gail Broder as the keynote speaker.

Amber Massey Pictured L-R: Keith Richardson (Vanderbilt CRS), Shonda The Vanderbilt HIV Vaccine Sumner (Vanderbilt CRS), Program welcomes our new Alberta Hardison Dwayne Jenkins , Gail Broder Research Nurse Specialist Amber (HVTN Core), Jarissa Greenard Massey. Amber is a graduate “My volunteer work with the (Vanderbilt CRS), Amanda of the University of Memphis Vanderbilt HIV Vaccine program Langlois (Vanderbilt CRS). where she earned her Bachelors started because I wanted to do of Science in Nursing degree in something more. I saw a video Congratulations to our CAB Chair, 2015. Since then, she has worked on my local news station in 1998. Alberta Hardison, on receiving as a Registered Nurse at Vanderbilt I called and started in a trial. recognition for her 10-year University Medical Center for I was in the canarypox trial where working relationship with Brother’s 4 years. Amber transitioned into I received the vaccine, which United Network, Inc. We appreciate her new role as Research Nurse 1 made me have VISP . I often talk your partnership and efforts to Specialist at the beginning of 2020. to people about how much HIV reach our community! Her previous experience has been has changed within the last 20 with cardiology, but Amber found years in Nashville. When I started a passion to help in HIV vaccine volunteering, African Americans research and we are thrilled to have were not as willing to be a part her a part of the team. Amber has of the trials or talk about HIV, two children and 2 stepchildren especially in the South. This has with her husband, who is also changed a lot and I have worked a VUMC nurse. “I am so excited hard to be out in the community to be a part of the team, and I feel to help educate and let people like the work you guys (and now, know about HIV vaccine research.” I) do is a way to really make

1- VISP is an acronym that stands for Vaccine-Induced a difference.” SeroPositivity. Antibodies help to prevent infection. Most vaccines cause the body to make antibodies. If you get Pictured: Keith Richardson an HIV vaccine, your body may make antibodies to HIV. (Vanderbilt CRS), Alberta However, standard HIV tests search for HIV antibodies, a sign of HIV infection for people who have not previously Hardison (Vanderbilt CRS received an HIV vaccine. If you get a standard HIV test after CAB Chair), Jarissa Greenard receiving an HIV vaccine, your HIV test results could come back positive even if you are not infected with HIV. This (Vanderbilt CRS). is called a VISP test result.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 30 Site Update

A FLEETING 72 HOURS INSCRIBED TO MEMORY

By: Aziel Gangerdine, HVTN Core, Seattle, WA, USA

At approximately 8:30 a.m. I stepped Center is a beacon of hope in the into the cool clinic entrance of community of Houston offering the Crofoot Research Center, Inc. research and LGBTQ focused and was instantly relieved from healthcare. the city’s humidity, the effects of which had become noticeable by In 2017 an estimated 1,133 new HIV the damp blotches on my dress diagnoses were documented in the shirt. I had arrived at one of the city of Houston of which Black and more than 50 global clinical trial Hispanic/Latinx communities bear sites participating in the Mosaico a disproportionate burden, with an study after my flight from Seattle, estimated 48.2%, 34.8% and 12.9% Washington landed in Houston, of new HIV transmissions reported Texas a little shy of 4 hours and among Black, Hispanic/Latinx, and 40 minutes. The next 72 hours of white communities, respectively1. invaluable experiences, and what seemed fleeting, were inscribed to “While Houston has some of the my memory. leading medical treatment and research facilities in the world, we A milestone, in the phase III HIV still bear a disproportionate burden Maggie White, MPH, APRN, FNP- vaccine efficacy study announced in the amount of persons living BC, AAHIVS, Study Spokesperson, earlier in July by a consortium of with and affected by HIV,” said Crofoot Research Center global partners, was scheduled to Maggie White, MPH APRN FNP-BC take place. The study team led by AAHIVS, study spokesperson for working with the community Dr. Gordon Crofoot would inject the Crofoot Research Center, Inc. they serve. Since 1985, the Center Mosaico’s first study participant Among transgender communities, had conducted more than 130 setting in motion the testing of 12 transgender men (assigned clinical trials, the majority being an investigational mosaic-based female at birth) and 252 transgender interventional HIV, hepatitis C virus vaccine regimen with the goal women (assigned male at birth) (HCV), hepatitis B virus (HBV) and of determining if it is effective in were reported to be living with HIV some other indications. preventing the transmission of in Houston in 20171. HIV infection in men who have sex I needed to understand how the with men (MSM), and transgender “We hope that by conducting this team earned the support and individuals aged 18-60. study in Houston, we can celebrate involvement of the community on and reflect the diversity of our their scientific journey to conduct During the initial hours of the first city in HIV prevention research”, numerous clinical trials. 24 I was immersed in facts and the concluded White. tale of how a legacy was built dating “We view community engagement back to 1985 when Dr. Crofoot first Time marched on and 48 hours as being the tree trunk which started doing research with the drew close. I listened to more facts supports HIV research,” said Frankie initial testing of AZT as a single and figures at the dinner table Garcia, Study Coordinator for the agent for the treatment of HIV. and was indulged by the team’s Crofoot Research Center, Inc. “The More than three decades on and the enthusiastic conversation about tree trunk has many roots which

31 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 reaches out to all the different “Our networks are strong, and we study injection. “Whatever the groups representative of our have been fortunate to have earned outcome of the study, we all can community”, Garcia explained in a the trust of our community over look back and say we bore witness pleasant demeanor and warm smile. many years of advocacy, love, and and were able to contribute to the mutual respect”, Garcia added. goals of the study. Being part In the early days, according to the of this program is one of the team, the Crofoot Research Center, At approximately 9:30 p.m. (CDT) on highest points in our careers”, Inc. studies were driven by the Thursday, November 21, 2020 the Sydnor concluded. community, with advocates being first study participant enrolled in the link between the study team and the Mosaico study was injected at HIV patients hopeful for any chance the Crofoot Research Center, Inc. At of treatment. the time of print, study participants were enrolled across clinical trial sites in the United States, Argentina and Spain. These include Hope Clinic (Atlanta), Fenway (Boston), Orlando (Florida), Philadelphia (Pennsylvania), Rochester (New York), Bridge HIV (San Francisco), Montbau (Barcelona), Buenos Aires (Argentina), Logan Circle (Washington DC), and the Crofoot Research Center, Inc. (Houston).

“For many of us on the team, being part of this endeavor and here for this first injection, is an unimaginable gift,” Charles Sydnor, Project Manager for the Crofoot Charles Syndor, Project Manager, Frank Garcia, Study Coordinator, Research Center, Inc. conveyed Crofoot Research Center Crofoot Research Center as we stood in the clinic hallway having been present for the first Continued on the next page... Profile of Mosaico (HVTN 706/HPX3002)

• Study teams aim to enroll 3,800 cisgender men and transgender people who have sex with cisgender men and/or transgender people between the ages of 18-60 years. • The study will take place at over 50 trial sites in the U.S., Mexico, Brazil, Peru, Argentina, Poland, Italy and Spain. • Mosaico will evaluate an investigational mosaic-based vaccine regimen with the goal of determining if it is effective in preventing HIV infection in MSM and transgender individuals. • Initial results from the study may be available by 2024. • Public-private partnership making the search for a safe and globally effective preventive HIV vaccine possible • Mosaico is supported by a public-private partnership led by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson; the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH); and the NIAID-funded HIV Vaccine Trials Network (HVTN). Additional partners providing support include the U.S. Army Medical Research and Development Command (USAMRDC).

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 32 Site Update 72 Hours - it was fleeting but I recall engagement for the Mosaico A guiding principle of the HVTN is the friendly introductions, sincere Study globally. It was fitting to get the need for a strong bi-directional conversations and the abundance of Stephaun’s insights on the value partnership between the clinical information enthusiastically shared and importance of community trial site and the local community by the Crofoot Research Center, Inc. engagement strategies to help to help facilitate innovation and study team. I will treasure most the maintain the momentum of a advances in HIV biomedical moment of audible silence in the clinical trial in consideration of the research, foster trust and an clinic’s hallway as we all waited with impact of COVID-19 and how to understanding between the site bated breath to receive confirmation keep communities engaged. staff and local community, to ensure of the first injection, penning a page that research strategies honor and in history of a study participant and Each clinical trial site, via their respect the myriad of differences a committed team who are part of a community engagement plan among study participants. This global endeavor to help end HIV. and Community Advisory Board, partnership is underscored by the are equipped with the tools and unique community engagement Responding to Challenges strategies to communicate updates plan that each site develops. to Maintain Study Momentum or changes in the conduct of clinical trials when the need arises “Every person is unique, and every On March 11, 2020 the World Health for any reason, including the recent geographic location where our Organization declared COVID-19 impact of COVID-19. sites are working to engage local a global pandemic following the communities is also unique and deaths of a significant number “There is no one-size fits all diverse. Our strategies to reach of people around the world. approach to the specific activities to those persons must also be unique The situation rapidly evolved, educate communities, and recruit and diverse”, Wallace concluded. and countries responded with and retain study participants”, said unprecedented measures to stop Stephaun Wallace, PhD., HVTN Source1: aidsvu.org the transmission of SARS-CoV-2 the Social and Behavioral Sciences virus that causes COVID-19. Junior Investigator Liaison. “Each Aziel Gangerdine is the Director of clinical trial site develops a unique Communications for the HVTN based Within days following the community engagement plan, in Seattle, WA. declaration of a pandemic, the HIV which is informed and approved prevention research enterprise by the local community, so that it implemented measures to mitigate represents the voices and social the impact of COVID-19 on the norms of that local community,” conduct of clinical trials. Mosaico is Wallace pointed out. one of the many HIV clinical trials, coordinated by the HIV Vaccine Trials Network (HVTN), that is impacted by COVID-19.

At the time of going to print the leadership of the Mosaico Study implemented measures to minimize the impact of COVID-19 on the study and prioritize the safety of study participants and the clinic team. The leadership held weekly updates with the trial sites to inform decision making as the circumstances evolved.

I reached out to Stephaun Wallace, Ph.D., who is the HVTN’s Social Stephaun Wallace, PhD., HVTN and Behavioral Sciences Junior Social and Behavioral Sciences Investigator Liaison, and who Junior Investigator Liaison directs and manages community

33 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 A JOURNEY TOWARDS A GLOBAL HIV VACCINE

HIV VACCINE TRIALSwww. NETWORK | mosaicostudy COMMUNITY COMPASS | VOLUME.com 20, ISSUE 1: JUNE 2020 34 Public Statement Public statement by the HIV Vaccine Trials Network (HVTN) on COVID-19

April 1, 2020 We acknowledge and thank all An update on the status of Our mission remains the pursuit members of our communities the large-scale clinical trials of a safe and globally effective and organizations who are at the coordinated by the HVTN is preventive HIV vaccine to help forefront helping in the response provided in the accompanying end HIV. We appreciate the to overcome COVID-19. We laud table: Impact of COVID-19 on collaborative efforts at all sites to your service and unwavering large-scale antibody-mediated HIV ensure the safety of participants commitment! prevention efficacy clinical trials and staff and preserve the scientific and HIV vaccine efficacy trials integrity of each clinical trial. The HVTN continues to monitor the impact of COVID-19 on the As a general approach all trial sites Enquiries: conduct of the early and large- are implementing the following HVTN Director of Communications scale clinical trials it coordinates measures to stop the transmission Aziel Gangerdine globally. We remain committed of COVID-19: Email: [email protected] to the safety and wellbeing of all study participants and study teams. • Schedule telephone or virtual study participant visits In a previous statement, www.hvtn.org/en/media-room/ • Require those with a scheduled news-releases/public-statement- appointment to contact the site HIV-vaccine-trials-network_HVTN- beforehand if they feel unwell COVID-19_March-2020.html, we outlined how our study teams • Encourage physical distancing are empowered to implement to minimize potential measures necessary to prevent the exposures in the waiting possible transmission of COVID-19 area or while visits are being at each trial site. All measures are conducted aligned with the recommendations and guidance from local public • Monitor the temperatures of health authorities and Institutional the clinic staff and participants Review Boards (IRBs)/Ethics on entering the clinic Committees (ECs). In addition, some trial sites abide by specific • Frequently clean and disinfect requirements if they are part all surfaces of a larger research organization or health care facility. • Frequently hand wash with soap for at least for 20 seconds. The impact of COVID-19 is evolving rapidly and many countries are introducing response measures such as school and business closures and asking people to stay home. All measures aim to stop transmission and save lives. Editor’s note: Due to the time between when this statement was developed and publication of HVTN Community Compass, there may have been changes to our measures. For public inquiries about the current operational status of our studies, please contact Aziel Gangerdine at [email protected].

35 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 Impact of COVID-19 on Large-ccale Antibody-Mediated HIV Prevention Efficacy Clinical Trials and HIV Vaccine Efficacy

Current What Has HVTN Clinical Trial Countries Status Changed HVTN 703/HPTN 081 The leadership of the AMP study has Two studies are HVTN 704/HPTN 085 discontinued all further infusions in underway in 11 countries: (Antibody Mediated Prevention the interest of staff and participant Botswana, Brazil, Studies (AMP)) safety. The data accrued on infusions Fully Kenya, Malawi, AMP is testing whether a broadly already administered are sufficient to Mozambique, Peru, enrolled South Africa, neutralizing antibody (bnAb), achieve the study objectives. Participant called VRC01 can prevent HIV follow-up continues, utilizing remote Switzerland, or in-person visits, as feasible. Tanzania, United acquisition in people. States and Zimbabwe.

HVTN 705/HPX2008 (Imbokodo) To ensure the health and safety of study South Africa, Malawi, participants and staff, the leadership Mozambique, Imbokodo is testing an Zambia, and investigational vaccine of the Imbokodo Study has issued Zimbabwe. regimen based on “mosaic” guidance that is specific to the particular immunogens – vaccine circumstances of participating countries components comprising and study sites. Where appropriate, elements from multiple HIV this guidance may include temporarily Fully variants – designed to offer pausing vaccinations. enrolled protection against a variety of global HIV strains. The study has enrolled women aged 18-35 with the goal of determining if the vaccine regimen is effective in preventing HIV infection.

HVTN 706/HPX3002 (Mosaico) To ensure the health and safety of study Argentina, Brazil, Italy, Mexico, Peru, Mosaico is testing an participants and staff, the leadership Poland, Spain and investigational mosaic-based of the Mosaico Study has temporarily the United States. vaccine regimen that is very paused all new screening, enrollment, similar to the regimen being and vaccination visits through May studied in Imbokodo, with 1, 2020. The pause will be reassessed the goal of determining if it Enrolling periodically to determine next steps. is effective in preventing HIV infection in men who have sex with men (MSM), and transgender individuals aged 18-60.

HVTN 702 (Uhambo) Vaccinations The leadership of the Uhambo Study South Africa. Uhambo tested an experimental stopped in has empowered each participating vaccine regimen against HIV, February site to implement measures aligned that builds on the regimen 2020, but to guidance from local public health tested in the RV144 clinical trial participant authorities and Ethics Committees. conducted in Thailand. follow-up This includes expanding visit windows, continues. delaying visits and/or conducting some visit procedures remotely.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 36 37 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 1: JUNE 2020 38 The HIV Vaccine Trials Network is an international multi–disciplinary collaboration. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health, an agency of the U.S. Department of Health and Human Services. The Network and NIAID have a close, cooperative working relationship, with shared attention to intellectual and scientific issues.

ABOUT COMMUNITY COMPASS The Community Compass aims to keep the HVTN community informed about the Network’s research, site activities, and advances in the field of HIV prevention and vaccination. We encourage community members to submit news and event reports to this magazine and make this a true community sharing platform.

Translations in Spanish, Portuguese and French provided by Northwest Translations, Inc. www.nwtranslations.com

Editor-in-Chief: Stephaun E. Wallace, Ph.D. Layout & Design: Cody Shipman Production & Distribution: Nina Feldman Contributor: Aziel Gangerdine Contributing Editor: Gail Broder

SEND INQUIRIES ABOUT THIS ISSUE OF COMMUNITY COMPASS TO: Stephaun E. Wallace, [email protected]

VIEW PAST ISSUES OF COMMUNITY COMPASS AT hvtn.org/en/community/community-compass.html

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