SARS-Cov-2 Protein Subunit Vaccination Elicits Potent Neutralizing Antibody Responses
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Boosting Our Best Shot
NEWS FEATURE Boosting Our Best al orr a C rin Ma s by Shot ration Illust Vaccines work by training the immune system to target pathogens, but many types of shots need added substances called adjuvants to elicit a robust response. Despite the power of adjuvants, only one, called alum, is approved in the US. Charlotte Schubert looks at recent discoveries that could translate into a wider range of adjuvants and perhaps help provide future protection against diseases ranging from malaria to H1N1 ‘swine’ flu. © All rights reserved. 2009 Inc. Nature America, Max Theiler never thought it would be easy to particularly good at bumping up the immune FDA is poised to give the green light to such vanquish one of the biggest killers of his time. response. By comparison, most vaccines adjuvanted vaccines, lined up for approval in Yellow fever had already stumped a previous developed today rely on bits of microbes, such Europe, remains unclear (see sidebar). generation of microbe-hunters. And in the as short protein sequences—and they don’t For many years, researchers such as Theiler early 1900s it killed subjects who volunteered work quite so well on their own. To elicit an moved their vaccine candidates forward with for experiments in which they received bites immune response, these vaccines typically little mechanistic understanding of how they from mosquitoes, proving that the insects need a jolt from an adjuvant, a substance worked. That empirical approach is ending, transmit the disease. named from the Latin ‘adjuvans’, which says Bali Pulendran, an immunologist at the Theiler’s work was painstaking. -
Lessons Learnt from Influenza A(H1N1) Vaccines Benefit-Risk Monitoring Encepp Plenary Meeting
Lessons learnt from Influenza A(H1N1) vaccines benefit-risk monitoring ENCePP Plenary meeting Xavier Kurz 8 June 2010 An agency of the European Union ContentsContents 1. Safety database at time of authorisation 2. Mechanisms for vaccine safety surveillance 3. What worked well 4. Areas for improvement of vaccine vigilance system 5. On-going work 2 1. Safety database at time of authorisation Pandemrix • H5N1 vaccine: 6,100 subjects – 300 children 3-9 years, 5,071 adults 18-60 years, 729 elderly >60 years • H1N1 vaccine: 130 adults 18-60 years Focetria • H5N1 vaccine: 1,496 subjects – 145 children 6-35 months, 96 children 3-8 years, 93 children 9-17 years, 989 adults 18-60 years, 173 elderly >60 years • H1N1 vaccine: none Celvapan • H5N1 vaccine: 836 subjects – 556 adults 18-60 years, 280 elderly > 60 years • H1N1 vaccine: none Safety profiles observed with H5N1 vaccines expected to be generally applicable to A/H1N13 vaccines. Limited data in children and pregnant women. European Strategy published on 5 November 2009 http://www.emea.europa.eu/pdfs/human/pandemicinfluenza/european_strategy.pdf or: EMEA website Æ Pandemic influenza website Æ Latest news 4 2. Vaccine safety surveillance Marketing Authorisation Holders • Monthly simplified Periodic Safety Update Reports (s-PSUR) • Summary of important information from spontaneous reports and analysis of safety issues in populations at risk • PASS of 9,000 subjects for each vaccine stratified by age • As soon as vaccination starts • Pregnancy registries • Creation or collaboration with existing -
Recent Zoonotic and Vector-Borne Viral Threats NIAID Vaccine
4/1/2020 PROTOTYPE PATHOGEN APPROACH TO PANDEMIC PREPAREDNESS HIV→PNEUMOVIRUS→PARAMYXOVIRUS→CORONAVIRUS ADVAC Alumni 2 April 2020 Barney S. Graham, MD, PhD Deputy Director Vaccine Research Center, NIAID, NIH 1 Recent Zoonotic and Vector-borne Viral Threats • Hanta virus • Nipah/Hendra • West Nile virus • SARS • Influenza • Chikungunya • Ebola • MERS • Zika • EV‐D68 • SARS‐CoV‐2 2 NIAID Vaccine Research Center Basic Research Process Development Nucleic acid Vectors VLPs • AIDS/HIV • Influenza Proteins and cGMP Manufacturing nanoparticles • Ebola/Marburg • RSV • Malaria Monoclonal antibodies • Tuberculosis • EID GLP Analysis • West Nile virus, Zika • Chikungunya • W/E/V equine encephalitis viruses • MERS‐CoV, SARS, and other CoV • Nipah and other paramyxoviruses • EV‐D68 and other picornaviruses Clinical Trials • Smallpox 3 1 4/1/2020 Public health burden of re-emerging & emerging viruses Traditional Approaches • Licensed vaccines/antibiotics Vaccine • Passive surveillance Challenges • Contact tracing • Quarantine • Vaccines for unmet needs • Emerging viruses • Improving licensed vaccines 4 4 New Technologies are Transforming Vaccinology • Structure-based vaccine design Structural analysis of antigenic sites on viral • Single-cell sorting, sequencing, and bioinformatics surface glycoproteins – Rapid isolation of human mAbs Isolation of human monoclonal – Definition of antibody lineages antibodies from single B cells – Analysis of immune responses • Protein engineering of self-assembling nanoparticles • Rapid DNA synthesis • Recombinant -
1 Title: Interim Report of a Phase 2 Randomized Trial of a Plant
medRxiv preprint doi: https://doi.org/10.1101/2021.05.14.21257248; this version posted May 17, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. 1 Title: Interim Report of a Phase 2 Randomized Trial of a Plant-Produced Virus-Like Particle 2 Vaccine for Covid-19 in Healthy Adults Aged 18-64 and Older Adults Aged 65 and Older 3 Authors: Philipe Gobeil1, Stéphane Pillet1, Annie Séguin1, Iohann Boulay1, Asif Mahmood1, 4 Donald C Vinh 2, Nathalie Charland1, Philippe Boutet3, François Roman3, Robbert Van Der 5 Most4, Maria de los Angeles Ceregido Perez3, Brian J Ward1,2†, Nathalie Landry1† 6 Affiliations: 1 Medicago Inc., 1020 route de l’Église office 600, Québec, QC, Canada, G1V 7 3V9; 2 Research Institute of the McGill University Health Centre, 1001 Decarie St, Montreal, 8 QC H4A 3J1; 3 GlaxoSmithKline Biologicals SA (Vaccines), Avenue Fleming 20, 1300 Wavre, 9 Belgium; 4 GlaxoSmithKline Biologicals SA (Vaccines), rue de l’Institut 89, 1330 Rixensart, 10 Belgium; † These individuals are equally credited as senior authors. 11 * Corresponding author: Nathalie Landry, 1020 Route de l’Église, Bureau 600, Québec, Qc, 12 Canada, G1V 3V9; Tel. 418 658 9393; Fax. 418 658 6699; [email protected] 13 Abstract 14 The rapid spread of SARS-CoV-2 globally continues to impact humanity on a global scale with 15 rising morbidity and mortality. Despite the development of multiple effective vaccines, new 16 vaccines continue to be required to supply ongoing demand. -
Multivalue Ethical Framework for Fair Global Allocation of a COVID-19
Clinical ethics Multivalue ethical framework for fair global J Med Ethics: first published as 10.1136/medethics-2020-106516 on 12 June 2020. Downloaded from allocation of a COVID-19 vaccine Yangzi Liu ,1 Sanjana Salwi,1 Brian Drolet2 1School of Medicine, Vanderbilt ABSTRact by a global scarcity of vaccines, increasing vaccine University, Nashville, Tennessee, The urgent drive for vaccine development in the midst price and worsening inequity and disparity. There- USA 2 fore, it is unlikely that donations from high- income Center for Biomedical Ethics of the current COVID-19 pandemic has prompted public and Society, Vanderbilt and private organisations to invest heavily in research countries or through organisations like GAVI will University Medical Center, and development of a COVID-19 vaccine. Organisations ensure fair distribution of a pandemic vaccine Nashville, Tennessee, USA globally have affirmed the commitment of fair global without a solid ethical framework for allocation. access, but the means by which a successful vaccine This piece analyses four allocation paradigms and Correspondence to can be mass produced and equitably distributed synthesises their ethical considerations to develop a Ms Yangzi Liu, Vanderbilt model to fit the COVID-19 pandemic. University School of Medicine, remains notably unanswered. Barriers for low- income Nashville, TN 37232, USA; countries include the inability to afford vaccines as well yangzi. liu@ vanderbilt. edu as inadequate resources to vaccinate, barriers that are Principle 1: Ability to develop or to purchase exacerbated during a pandemic. Fair distribution of Vaccine distribution is currently determined by two Received 27 May 2020 a pandemic vaccine is unlikely without a solid ethical Accepted 4 June 2020 primary considerations: (1) ability to develop and framework for allocation. -
Proposed Minutes
Approved 07/19/2021 MINUTES ST. CLAIR SHORES CITY COUNCIL MEETING JUNE 21, 2021 Regular Meeting of the City Council, held in the Council Chambers, located at 27600 Jefferson Avenue., St. Clair Shores, Michigan. Present: Mayor Kip C. Walby, Council Members Peter Accica, John Caron, Ron Frederick, David Rubello, Candice Rusie and Chris Vitale Also Present: City Manager Matthew Coppler, City Clerk Mary Kotowski, Deputy City Clerk Abby Hauff, Directors Henry Bowman, Chris Rayes and Laura Stowell and City Attorney Robert Ihrie 1. CALL TO ORDER, ROLL CALL AND PLEDGE OF ALLEGIANCE Mayor Walby called the meeting to order at 7:00 p.m. Ms. Kotowski, City Clerk, called the roll, and a quorum was present. The Pledge of Allegiance was recited. Mayor Walby introduced Abby Hauff, the new Deputy City Clerk, and she said a few words. 2. PROCLAMATIONS & PRESENTATIONS a. Memorial Day Parade Trophy Presentation Cheryl Furdos, Memorial Day Parade Committee Chairperson, and Mayor Walby presented trophies to the following winners: The Best Color Guard - U.S. Air Force Honor Guard; The Best Special Entry - Eddie Munster and the Munster Koach; The Best Patriotic Float - Viviano Flower Shop; The Best Band - 338th Army Band; The Best School Band - Lakeview Marching Band; The Best Overall Float - SCS Baseball & Softball Association and Lac Ste. Claire Kiwanis, which was also the Mayor’s Choice; The Best Overall Entry - The Arsenal of Democracy Museum; and the Chairwoman’s Choice - Cub Scout Pack #2018. b. Dr. Jason McLellan Proclamation Mayor Walby presented the following proclamation to Mr. and Mrs. McLellan who were present on behalf of their son Dr. -
Kizzmekia S. Corbett
KIZZMEKIA S. CORBETT, PHD Senior Research Fellow National Institutes of Health | National Institute of Allergy and Infectious Diseases | Vaccine Research Center 40 Convent Drive, Building 40 - Room 2608, Bethesda MD 20892 [email protected] | phone: 301.761.7610 | fax: 301.480.2771 EDUCATION Doctor of Philosophy in Microbiology and Immunology 2014 University of North Carolina at Chapel Hill (UNC) Director’s Scholar Bachelor of Science in Biological Sciences | Secondary Major in Sociology 2008 University of Maryland – Baltimore County (UMBC) Robert and Jane Meyerhoff Scholar RESEARCH EXPERIENCE Research Fellow 10/14 - present National Institutes of Health | Vaccine Research Center | PI: Barney S. Graham, MD PhD Research Interest: mechanisms of viral immunity to inform influenza and coronavirus vaccine development Graduate Research Assistant 08/09 – 10/14 University of North Carolina at Chapel Hill | Microbiology and Immunology | PI: Aravinda de Silva, MPH PhD Research Interest: human antibody responses to dengue virus infection Visiting Scholar 04/14 – 05/14 Genetech Research Institute | PI: Aruna Dharshan de Silva, PhD Research Interest: immunological relevance of dengue virion maturation Postbaccalaureate Research Fellow 05/08 – 08/09 National Institutes of Health | Vaccine Research Center | PI: Barney S. Graham, MD PhD Research Interest: novel vaccine platform design for respiratory syncytial virus antigens NIH Undergraduate Scholarship Program Summer Intern 06/07 – 08/07 National Institutes of Health | Vaccine Research Center -
Better Pandemic Influenza Preparedness Through
Review Better Pandemic Influenza Preparedness through Adjuvant Technology Transfer: Challenges and Lessons Learned Céline H. Lemoine 1,2,*, Reviany V. Nidom 3, Roland Ventura 2, Setyarina Indrasari 3, Irine Normalina 3, Kuncoro Puguh Santoso 3,4, Francis Derouet 5, Christophe Barnier-Quer 6,7, Gerrit Borchard 1 , Nicolas Collin 2 and Chairul A. Nidom 3,4 1 Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, Rue Michel-Servet 1, 1221 Geneva, Switzerland; [email protected] 2 Vaccine Formulation Institute, Chemin des Aulx 14, 1228 Plan-les-Ouates, Switzerland; [email protected] (R.V.); [email protected] (N.C.) 3 Professor Nidom Foundation, Surabaya 60298, Indonesia; reviany@pnfinstitute.org (R.V.N.); setyarina_ire@pnfinstitute.org (S.I.); irine_normalina@pnfinstitute.org (I.N.); kuncoropuguhsantoso@pnfinstitute.org (K.P.S.); [email protected] (C.A.N.) 4 Faculty of Veterinary Medicine, Universitas Airlangga, Surabaya 60115, Indonesia 5 Centre Laboratoire d’Epalinges (CLE), University of Lausanne, Ch. des Boveresses 155, 1011 Epalinges, Switzerland; [email protected] 6 Vaccine Formulation Laboratory, University of Lausanne, Ch. des Boveresses 155, 1066 Epalinges, Switzerland; [email protected] 7 GALVmed, Doherty Building, Pentlands Science Park, Bush Loan, Edinburgh EH26 0PZ, UK * Correspondence: [email protected] Citation: Lemoine, C.H.; Nidom, R.V.; Ventura, R.; Indrasari, S.; Abstract: Adequate global vaccine coverage during an influenza pandemic is essential to mitigate Normalina, I.; Santoso, K.P.; Derouet, morbidity, mortality, and economic impact. Vaccine development and production needs to be F.; Barnier-Quer, C.; Borchard, G.; sufficient to meet a vast global demand, requiring international cooperation and local vaccine Collin, N.; et al. -
Possible Options for Using a Who H5n1 Vaccine Stockpile
Meeting summary TECHNICAL CONSIDERATIONS ON HUMAN H5N1 INFLUENZA VACCINES: POSSIBLE OPTIONS FOR USING A WHO H5N1 VACCINE STOCKPILE During 1-3 October 2007, WHO held a consultation in Geneva to review available data on the safety and immunogenicity of H5N1 vaccines, and possible options for the use of H5N1 vaccines as well as a WHO stockpile of such vaccine. Invited participants included researchers, representatives from WHO Influenza Collaborating Centres, selected countries, SAGE, and industry. Observers were allowed. Several presentations were provided including a summary of the results of a recent consultation on H5N1 vaccines held by the European Centre for Disease Prevention and Control (ECDC).1 1. Characteristics of currently-available human H5N1 influenza vaccines Safety: Based on currently available data from animal and limited human clinical trials, there is no evidence so far of any identifiable major safety concern related to H5N1 vaccines, although additional local reactions with some adjuvanted vaccines have been noted. Additional controlled trials with long-term follow up, especially in children, are needed. If a live attenuated vaccine based on the H5N1 virus is used in a non-pandemic period, there is a risk the vaccine virus could reassort with a circulating seasonal human influenza virus an create a hybrid virus, but this risk was considered small. If any type of H5N1 vaccine is used extensively, additional adverse safety signals can be anticipated. Part of the preparations for widespread use should include ongoing monitoring to ensure that adverse events are identified and appropriate responses are taken. Immunogenicity: Currently there are no standard criteria to assess the immunogenicity of human H5N1 vaccines. -
DNA-Launched RNA Replicon Vaccines Induce Potent Anti-SARS-Cov-2
www.nature.com/scientificreports OPEN DNA‑launched RNA replicon vaccines induce potent anti‑SARS‑CoV‑2 immune responses in mice Inga Szurgot*, Leo Hanke, Daniel J. Sheward, Laura Perez Vidakovics, Ben Murrell, Gerald M. McInerney & Peter Liljeström The outbreak of the SARS‑CoV‑2 virus and its rapid spread into a global pandemic made the urgent development of scalable vaccines to prevent coronavirus disease (COVID‑19) a global health and economic imperative. Here, we characterized and compared the immunogenicity of two alphavirus‑ based DNA‑launched self‑replicating (DREP) vaccine candidates encoding either SARS‑CoV‑2 spike glycoprotein (DREP‑S) or a spike ectodomain trimer stabilized in prefusion conformation (DREP‑Secto). We observed that the two DREP constructs were immunogenic in mice inducing both binding and neutralizing antibodies as well as T cell responses. Interestingly, the DREP coding for the unmodifed spike turned out to be more potent vaccine candidate, eliciting high titers of SARS‑CoV‑2 specifc IgG antibodies that were able to efciently neutralize pseudotyped virus after a single immunization. In addition, both DREP constructs were able to efciently prime responses that could be boosted with a heterologous spike protein immunization. These data provide important novel insights into SARS‑ CoV‑2 vaccine design using a rapid response DNA vaccine platform. Moreover, they encourage the use of mixed vaccine modalities as a strategy to combat SARS‑CoV‑2. Te severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged as the causative agent of COVID- 19 in late 20191,2. Te disease pathology ranges from asymptomatic infection to severe acute respiratory distress and death3,4. -
Options for the Use of Human H5N1 Influenza Vaccines and the WHO H5N1 Vaccine Stockpile
Options for the use of human H5N1 influenza vaccines and the WHO H5N1 vaccine stockpile THIRD DRAFT – 02/11/07 WHO SCIENTIFIC CONSULTATION: TECHNICAL CONSIDERATIONS FOR DEVELOPING OPTIONS FOR USE OF HUMAN H5N1 INFLUENZA VACCINES AND A WHO H5N1 VACCINE STOCKPILE GENEVA, 01-03 OCTOBER 2007 GENEVA, 2007 CONTENTS Executive summary ................................................................................................... 3 1. Characteristics of human H5N1 influenza vaccines 1.1: Safety......................................................................................................................... 8 1.2: Immunogenicity....................................................................................................... 10 1.3: Cross-reactivity........................................................................................................ 12 1.4: Degree and duration of protection ........................................................................... 13 1.5: Conclusions and priority areas ................................................................................ 14 2. Options for using human H5N1 influenza vaccines................................ 16 2.1: To protect people at high risk of contracting zoonotic avian H5N1 influenza........ 17 2.2: To “prime” selected groups or whole populations in anticipation of a possible H5N1 influenza pandemic ....................................................................................... 18 2.3: To immunize selected groups or whole populations in anticipation of -
Safety and Immunogenicity of a Plant-Produced
Viruses 2012, 4, 3227-3244; doi:10.3390/v4113227 OPEN ACCESS viruses ISSN 1999-4915 www.mdpi.com/journal/viruses Article Safety and Immunogenicity of a Plant-Produced Recombinant Hemagglutinin-Based Influenza Vaccine (HAI-05) Derived from A/Indonesia/05/2005 (H5N1) Influenza Virus: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy Adults Jessica A. Chichester, R. Mark Jones, Brian J. Green, Mark Stow, Fudu Miao, George Moonsammy, Stephen J. Streatfield and Vidadi Yusibov * Fraunhofer USA, Center for Molecular Biotechnology, Newark, DE 19711, USA; E-Mails: [email protected] (J.A.C.); [email protected] (R.M.J.); [email protected] (B.J.G.); [email protected] (M.S.); [email protected] (F.M.); [email protected] (G.M.); [email protected] (S.J.S.); [email protected] (V.Y.) * Author to whom correspondence should be addressed; E-Mail: [email protected]; Tel.: +1-302-369-3766; Fax: +1-302-369-8955. Received: 25 October 2012; in revised form: 15 November 2012 / Accepted: 16 November 2012 / Published: 19 November 2012 Abstract: Recently, we have reported [1,2] on a subunit influenza vaccine candidate based on the recombinant hemagglutinin protein from the A/Indonesia/05/2005 (H5N1) strain of influenza virus, produced it using ‘launch vector’-based transient expression technology in Nicotiana benthamiana, and demonstrated its immunogenicity in pre-clinical studies. Here, we present the results of a first-in-human, Phase 1 randomized, double-blind, placebo-controlled study designed to investigate safety, reactogenicity and immunogenicity of three escalating dose levels of this vaccine, HAI-05, (15, 45 and 90 µg) adjuvanted with Alhydrogel® (0.75 mg aluminum per dose) and the 90 µg dose level without Alhydrogel®.