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The HVTN: Strategic Accomplishments of the First Decade and Beyond Tracey Day, Cecilia Morgan, Adi Ferrara, and Jim Kublin

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The HVTN: Strategic Accomplishments of the First Decade and Beyond Tracey Day, Cecilia Morgan, Adi Ferrara, and Jim Kublin a Publication of the HIV Vaccine Trials Network VOLUME 3, ISSUE 2 | MARCH, 2012 Welcome to a new edition of the Our featured article in this issue is a HVTNews, the newsletter of the HIV look back at the Network’s achieve- Vaccine Trials Network. Our newslet- ments in 12 years of operation, and ter’s mission is to provide timely up- the impact it had on the HIV vaccine dates on the science of HIV vaccines, field. and the science of the HVTN. To that end, this issue features discussions that The search for an HIV vaccine is as include innate immunity studies at relevant and urgent today as it was at the HVTN, the possible impact of the the outset of the epidemic. We hope RV144 Correlates Analyses on future this issue gives you a glimpse of the vaccine trials, and the Network’s myriad ways in which the HVTN ongoing commitment to its study par- pursues our ultimate goal -- eradica- ticipants via our VISP testing service. tion with vaccination. Post RV144 Selection of gp120 [p. 8]. Figure of HIV-1 gp120 Env protein (red), bound to CD4 (yellow) and 17b antibody (blue) provided by Jonathan Stuckey, Vaccine Research Center, NIAID, NIH. The HVTN: Strategic Accomplishments of the First Decade and Beyond Tracey Day, Cecilia Morgan, Adi Ferrara, and Jim Kublin The development of an effective HIV Streamlined Protocol has been streamlining the protocol vaccine is one of humanity’s greatest Development Process development and implementation scientific challenges. In acknowledg- process. This has been achieved largely ing that the path to an effective HIV Before a clinical trial can begin, a through efforts to bring stakeholders vaccine will likely require numerous trial protocol outlining the protocol’s to the table at the appropriate time iterative steps, the HVTN has aimed objectives, target population, and con- and ensure that all support opera- to improve the process of designing, duct must be approved. Defining and tions are in place at the projected trial implementing, and analyzing HIV compiling the required information opening date. vaccine clinical trials. Over the last is performed by the protocol team, decade, while conducting numerous which comprises a diverse group of A standard protocol template has also clinical trials, the Network has made stakeholders. They include community improved efficiency. A standardized significant scientific contributions to members, product experts, clinicians, template saves considerable time and the field and set precedents in com- laboratorians, statisticians, researchers, effort by allowing the focus to stay on munity engagement. These and other regulatory experts, and representa- the unique aspects of the particular major achievements are discussed tives from the Division of AIDS trial. The current template represents below (see Figure 1). (DAIDS), which usually sponsors the over a decade of historical learning by trial. A major Network achievement the HVTN. IN THIS ISSUE ARTICLES 1 The HVTN: Strategic Accomplishments of the First Decade and Beyond 13 Auxiliary Research Projects 2011 6 Highlights from the Plenary Sessions of the HVTN Fall Conference 18 VISP and the HVTN’s Commitment to Poststudy HIV Testing 9 The RV144 Immune Correlates Analysis: Implications for Vaccine Evaluation CALENDAR [back cover] 10 The Role of Innate Immunity in Vaccinology THE HVTN: STRATEGIC ACCOMPLISHMENTS OF THE FIRST DECADE AND BEYOND The protocol drafting process culminates in a “face to face can and Hispanic populations are among those at highest risk meeting” in which every team member signs off on a final for HIV infection, but are under-represented in clinical trials, protocol document that is then submitted to DAIDS for in part because of mistrust in medical research due to histori- review, and ultimately for regulatory submission. Together, cal abuses. To improve representation of these cohorts, the the measures outlined above significantly improve the proto- HVTN pioneered the Legacy Project. This project’s mission is col development process and thus minimize the time to trial to build trust between researchers and minority populations, opening. and its success led to expansion into all DAIDS-supported HIV research networks (http://www.hanc.info/legacy/Pages). Commitment to Community Engagement Generation of Robust Immunogenicity Data To successfully conduct vaccine clinical trials, it is necessary for trial sites to communicate with and educate the community From the beginning, the importance of a centralized labora- about HIV prevention and clinical trials. Community advisory tory program that provides standardized, high quality im- boards (CABs) provide a means for community members and munogenicity data was recognized. A major HVTN accom- vaccine researchers to interact and thereby give a voice to the plishment has been the establishment of a laboratory program communities where trials are conducted. The HVTN in- endowed with standardized processes, comprehensive quality volves CAB representatives throughout the life of a trial from assurance measures, and robust data management systems that protocol development through trial implementation, and CAB ensure data integrity for complex immunogenicity assays. members also sit on HVTN committees. Community educa- tion programs are also conducted at trial sites to enhance the The Laboratory Program invests significant effort in assay enrollment and retention of trial participants. development and optimization, as well as training in specimen handling at all trial sites. A large number of assays are per- Another example of the HVTN’s strong commitment to com- formed in HVTN trials, including multiple “validated” assays munity is the provision of treatment for trial participants who for which stringent pass/fail criteria are defined, “qualified” as- become infected with HIV.1 The Network ensures these indi- says, for which optimization studies have been completed, and viduals have access to antiretroviral treatment, and maintains several exploratory assays are conducted as well. funds to provide this treatment in the event that it is not avail- able. Following through on this commitment required strong Management of such vast and complex laboratory data poses community partnerships, especially in developing countries a number of challenges. For example, early phase trials place where treatment may not be easily accessible. high priority on rapid access to safety data. The data man- agement system must also function among trial sites which Preventive HIV vaccine candidates should be tested in a wide vary in their ability to support such systems. To meet these range of individuals to ensure that a developed vaccine is varied challenges, programmers at the Statistical Center for protective in diverse populations. In the U.S., African Ameri- HIV/AIDS Research and Prevention (SCHARP) created an 2006 2002 Legacy Project consul- tation with Hispanic/ Latino and African- First “Face to Face” American leaders 2001 protocol meeting 2003 2005 Web portal for assay Sieve analysis Protocol development Commitment to ensure Neutralizing antibody data management developed process improvement ARV treatment assay validated 2004 initiated STRATEGIC ACCOMPLISHMENTS ACHIEVED BY THE HVTN 2 MARCH 2012 VOLUME 3:2 | HVTNEWS THE HVTN: STRATEGIC ACCOMPLISHMENTS OF THE FIRST DECADE AND BEYOND integrated web portal system that allows incoming data to be “sieve analysis” methods. This novel approach determines monitored daily from any computer. This allows laboratory whether and how vaccine efficacy selectively blocks HIV staff to respond immediately to any deviations in specimen acquisition with certain HIV genotypes, and/or drives the or assay data at specific sites, and allows clinical development evolution of infecting viruses.8 In a collaborative effort that staff to assess safety data in a continuous manner. included SCHARP statisticians, sieve analysis methods were carried out for the Step study, and provided the first evidence Thus far, immunogenicity data typically serves as the driv- that a T-cell-based vaccine can have an effect on HIV-1.9 ing force for critical decisions on advancing products through clinical phases, since the majority of products tested by the Identification of immune responses that reliably predict vac- 2,3 HVTN to date have not generated adverse safety concerns. cine efficacy is a primary goal of vaccine research. The RV144 The Network’s efforts to generate robust immunogenicity HIV vaccine regimen, in a trial conducted by the U.S. Military data, therefore, provide the HVTN with the best possible HIV Research Program (USMHRP) and the Thai Ministry means with which to drive vaccine development. In addition, of Health, offered a modest vaccine efficacy of 31.2%, but pro- these measures yield a wealth of valuable resources to the field vided, for the first time, an opportunity to examine potential through assay methodology, reagent sharing, and the provision immune responses correlating with infection risk.10 SCHARP of high quality specimens to collaborators conducting ancillary statisticians and the HVTN Laboratory Program participated studies. in a large collaborative effort to investigate potential vaccine induced immune responses that correlated with HIV infection Statistical Leadership risk in the RV144 study. The group’s successful identification of two such correlates of risk was a major highlight of the The HVTN has been extremely fortunate to work with statis- recent AIDS Vaccine conference held in Bangkok, Thailand.11 ticians that are leaders
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