Px Wire: on HIV Prevention Research Volume 1 | No
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
HIV/AIDS Technologies: a Review of Progress to Date and Current Prospects
Working Paper No.6 HIV/AIDS Technologies: A review of progress to date and current prospects COMMISSIONED BY: aids2031 Science and Technology Working Group AUTHORED BY: KEITH ALCORN NAM Publications Disclaimer: The views expressed in this paper are those of the author(s) and do not necessarily reflect the official policy, position, or opinions of the wider aids2031 initiative or partner organizations aids2031 Science and Technology working group A review of progress to date and current prospects October 2008 Acronyms 3TC lamivudine ANRS Agènce Nationale de Récherche sur la Sida ART Antiretroviral therapy ARV Antiretroviral AZT azidothymidine or zidovudine bDNA branched DNA CDC US Centers for Disease Control CHER Children with HIV Early Antiretroviral therapy (study) CTL Cytotoxic T-lymphocyte D4T stavudine DSMB Data and Safety Monitoring Board EFV Efavirenz ELISA Enzyme Linked Immunosorbent Assay FDC Fixed-dose combination FTC Emtricitabine HAART Highly Active Antiretroviral Therapy HBAC Home-based AIDS care HCV Hepatitis C virus HPTN HIV Prevention Trials Network HSV-2 Herpes simplex virus type 2 IAVI International AIDS Vaccine Initiative IL-2 Interleukin-2 LED Light-emitting diode LPV/r Lopinavir/ritonavir MIRA Methods for Improving Reproductive Health in Africa trial MSF Médecins sans Frontières MSM Men who have sex with men MVA Modified vaccinia Ankara NIH US National Institutes of Health NRTI Nucleoside reverse transcriptase inhibitor NNRTI Non-nucleoside reverse transcriptase inhibitor OBT Optimised background therapy PCR Polymerase -
2012 NIAID Jordan Report
THE JORDAN REPORT ACCELERATED DEVELOPMENT OF VACCINES 2012 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases Images on cover, from the top: Courtesy of the US Centers for Disease Control and Prevention; istock.com; Courtesy of the National Library of Medicine; Courtesy of MedImmune THE JORDAN REPORT ACCELERATED DEVELOPMENT OF VACCINES 2012 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases NIH Publication No. 11-7778 January 2012 www.niaid.nih.gov ADDITIONAL RESOURCES National Institute of Allergy and Infectious Diseases, www.niaid.nih.gov Vaccines.gov: your best shot at good health, www.vaccines.gov Centers for Disease Control and Prevention: Immunization Schedules, www.cdc.gov/vaccines/recs/schedules/ Table of Contents INTRODUCTION VACCINE UPDATES Foreword by Anthony S. Fauci, M.D. ......................................... 3 Dengue M. Cristina Cassetti, Ph.D. .......................................................... 95 Tribute by Carole A. Heilman, Ph.D. ......................................... 5 HIGHLIGHT BOX Vaccine Against Chikungunya Virus in Development EXPERT ARTICLES Gary J. Nabel, M.D., Ph.D. and Ken Pekoc ......................... 97 Vaccinomics and Personalized Vaccinology Severe Acute Respiratory Syndrome Gregory A. Poland, M.D., Inna G. Ovsyannikova, Ph.D. and Frederick J. Cassels, Ph.D. ............................................................ 98 Robert M. Jacobson, M.D. .............................................................11 HIGHLIGHT BOX Sex Differences in Immune Responses to Vaccines Vaccine Delivery Technologies Col. Renata J. M. Engler, M.D. and Mary M. Klote, M.D. ....... 19 Martin H. Crumrine, Ph.D. ................................................. 105 Immunization and Pregnancy West Nile Virus Flor M. Munoz, M.D. .................................................................. 27 Patricia M. Repik, Ph.D. -
Reigniting Recruitment
a Publication of the HIV Vaccine Trials Network VOLUME 4, ISSUE 1 | JULY, 2012 REIGNITING RECRUITMENT IN THIS ISSUE photo by Sid Niazi ARTICLES 02 Probing the Diversity of Vaccine Elicited HIV-1 Antibodies: Informed by the 18 Social and Behavioral Science in Clinical Trials of Biomedical HIV Prevention RV144 Correlates Analysis Interventions 03 Assays to Probe the Humoral Response 22 HVTN Annual Network Award Winners 06 Turning up the Heat in Miami 24 HVTN Protocols 07 Orlando HVTN 505 Study Site: From Challenges to Accomplishments CALENDAR [back cover] 10 Assessing Mucosal Immune Responses in HIV Vaccine Trials 13 Highlights from Recent HVTN Publications Probing the Diversity of Vaccine Elicited HIV-1 Antibodies: Informed by the RV144 Correlates Analysis Georgia D. Tomaras RV144, a trial conducted by the U.S. Military HIV Research IgG antibody responses (ie, ADCC and nAbs) might corre- Program and the Thai Ministry of Health, was the first HIV-1 late with decreased risk of infection if present with low levels vaccine study in which a modest efficacy (31.2%) of HIV-1 of Env IgA (higher levels of Env IgA seem to counteract the vaccination was shown. The study regimen consisted of a beneficial effects of IgG). Thus, the balance of antibody types, canarypox prime expressing Gag, Pro, and gp120 (ALVAC- and the interactions among them -- particularly in those with HIV), and a gp120 boost (AIDSVAX® B/E). These results different Fc receptor binding properties -- merits further study were published in the New England Journal of Medicine in to determine if specific Env antibody isotypes influence the 2009.1 level of vaccine efficacy. -
Improving Vaccine Design for Viral Diseases Using Modified Antigens and Vectors
University of Pennsylvania ScholarlyCommons Publicly Accessible Penn Dissertations 2017 Improving Vaccine Design For Viral Diseases Using Modified Antigens And Vectors Michael John Hogan University of Pennsylvania, [email protected] Follow this and additional works at: https://repository.upenn.edu/edissertations Part of the Virology Commons Recommended Citation Hogan, Michael John, "Improving Vaccine Design For Viral Diseases Using Modified Antigens And Vectors" (2017). Publicly Accessible Penn Dissertations. 2342. https://repository.upenn.edu/edissertations/2342 This paper is posted at ScholarlyCommons. https://repository.upenn.edu/edissertations/2342 For more information, please contact [email protected]. Improving Vaccine Design For Viral Diseases Using Modified Antigens And Vectors Abstract Two of the principal challenges facing vaccine design today are how to generate protective antibody responses against viruses that have evolved sophisticated strategies to evade the humoral immune system and how to more rapidly and effectively produce vaccines to address emerging epidemics. In this regard, we explored multiple strategies to improve vaccine design for HIV-1 and Zika virus. In one approach, we derived CD4-independent variants of HIV-1 envelope (Env) with the hypothesis that such Envs would expose conserved epitopes that may be targets of protective, non-neutralizing antibodies. We characterized the biological and structural properties of two CD4-independent Env clones and found that they exhibited significantly greater exposure of a relatively conserved, linear epitope in the second variable loop (V2) that had previously been associated with decreased risk of infection in a clinical HIV-1 vaccine trial. This epitope was significantly more immunogenic in mice and nonhuman primates and, intriguingly, was associated with more rapid development of antibody-dependent cell-mediated cytotoxicity. -
Ethical Considerations for Including Prep in a Phase Iib HIV Vaccine
CLINICAL Ethics TRIALS Clinical Trials 2015, Vol. 12(4) 394–402 Ó The Author(s) 2015 Testing the waters: Ethical Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1740774515579165 considerations for including PrEP in a ctj.sagepub.com phase IIb HIV vaccine efficacy trial Liza Dawson1, Sam Garner2, Chuka Anude3,PaulNdebele4,Shelly Karuna5, Renee Holt6,GailBroder5, Jessica Handibode7, Scott M Hammer8, Magdalena E Sobieszczyk8 for the NIAID HIV Vaccine Trials Network Abstract Background: The field of HIV prevention research has recently experienced some mixed results in efficacy trials of pre-exposure prophylaxis, vaginal microbicides, and HIV vaccines. While there have been positive trial results in some studies, in the near term, no single method will be sufficient to quell the epidemic. Improved HIV prevention methods, choices among methods, and coverage for all at-risk populations will be needed. The emergence of partially effective prevention methods that are not uniformly available raises complex ethical and scientific questions regarding the design of ongoing prevention trials. Methods: We present here an ethical analysis regarding inclusion of pre-exposure prophylaxis in an ongoing phase IIb vaccine efficacy trial, HVTN 505. This is the first large vaccine efficacy trial to address the issue of pre-exposure prophy- laxis, and the decisions made by the protocol team were informed by extensive stakeholder consultations. The key ethi- cal concerns are analyzed here, and the process of stakeholder engagement and decision-making described. Discussion: This discussion and analysis will be useful as current and future research teams grapple with ethical and sci- entific study design questions emerging with the rapidly expanding evidence base for HIV prevention. -
The Jordan Report: Accelerated Development of Vaccines 2007
THE JORDAN REPORT ACCELERATED DEVELOPMENT OF VACCINES 2007 U. S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases NIH Publication No. 06-6057 May 2007 www.niaid.nih.gov Images on cover, clockwise from top: © The World Bank; Courtesy of the National Library of Medicine; istock.com; Courtesy of the National Library of Medicine Table of Contents INTRODUCTION VACCINE UPDATES Introduction by Carole Heilman, Ph.D. .....................................3 Supporting the Nation’s Biodefense .........................................69 Animal Models for Emerging Infectious Diseases Tribute to Maurice R. Hilleman, Ph.D., and John R. La Montagne, Ph.D., by William S. Jordan, Jr., M.D. .....................5 Hepatitis C..................................................................................75 HIV/AIDS ...................................................................................77 EXPERT ARTICLES Dale and Betty Bumpers Vaccine Research Center The Immunology of Influenza Infection: Implications Human Papillomavirus (HPV) .................................................87 for Vaccine Development Cancer Vaccine Development at NCI Kanta Subbarao, M.D., M.P.H., Brian R. Murphy, M.D., Influenza .....................................................................................89 and Anthony S. Fauci, M.D........................................................11 Malaria ........................................................................................95 Vaccine -
Efficacy Trials and Progress of HIV Vaccines
ll Scienc Ce e f & o T l h a e n r a r a p p u u y y o o J J Journal of Cell Science & Therapy Asif and Irshad, J Cell Sci Ther 2017, 8:2 ISSN: 2157-7013 DOI: 10.4172/2157-7013. 1000265 Review Article Open Access Efficacy Trials and Progress of HIV Vaccines Daud Faran Asif1*, and Irshad M2 1Department of Biochemistry and Biotechnology, University of Gujrat, Pakistan 2Department of Biotechnology, University of Gujrat, Gujrat, Pakistan *Corresponding author: Daud Faran Asif, BS. Hons Student, Department of Biochemistry and Biotechnology, University of Gujrat, Pakistan, Tel: 92533643112; E-mail: [email protected] Rec date: Mar 18, 2017; Acc date: Apr 01, 2017; Pub date: Apr 04, 2017 Copyright: © 2017 Asif DF, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Discovery of HIV as causative agent of AIDS let to the belief that a vaccine for AIDS will be available shortly but was not that easy, and it took more than 30 years of hard laboratory and clinical work toward HIV vaccine development. Efficacy trials of RV144 and their results revealed that HIV vaccine is accomplishable. Clinical trials for developing bNAbs has monoclonal antibodies and to increase its half-life are also underway to achieve a proper HIV vaccine. In this review article, we see that how these efficacy trials are highlighting HIV vaccine concepts in clinical development. -
Study Protocol
Protocol HVTN 505 Phase 2b, randomized, placebo-controlled test-of- concept trial to evaluate the safety and efficacy of a multiclade HIV-1 DNA plasmid vaccine followed by a multiclade HIV-1 recombinant adenoviral vector vaccine in HIV-uninfected, adenovirus type 5 neutralizing antibody negative, circumcised men and male-to-female (MTF) transgender persons, who have sex with men DAIDS Document ID 10753 BB IND 13971 held by DAIDS Clinical trial sponsored by Division of AIDS (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Department of Health and Human Services (DHHS) Bethesda, Maryland, USA Vaccine provided by Dale and Betty Bumpers Vaccine Research Center (VRC), NIAID, NIH Bethesda, Maryland, USA July 21, 2014 HVTN 505, Version 6.0 HVTN 505, Version 6.0 / July 21, 2014 At the first planned interim analysis for efficacy futility, conducted under Version 4 of the protocol on April 22, 2013, the DSMB recommended that the trial be stopped for efficacy futility. A total of 71 HIV infections had been diagnosed in the MITT cohort (41 among vaccine recipients, 30 among placebo recipients). Of these, 48 constituted primary endpoints (Week 28+ HIV infections diagnosed on or after Day 196 post-enrollment); 27 occurred among vaccine recipients and 21 among placebo recipients. There was no statistically significant difference in the rate of HIV infection between treatment arms, either in the Week 28+ cohort (estimated hazard ratio = 1.25; 95% CI: 0.71 to 2.20; p = 0.446) or in the MITT cohort (hazard ratio = 1.33; 95% CI: 0.83 to 2.13; p = 0.230). -
Vaccination a CME Issue
Volume 90 No. 10 October 2007 Vaccination A CME Issue UNDER THE JOINT VOLUME 90 NO. 10 October 2007 EDITORIAL SPONSORSHIP OF: Medicine Health The Warren Alpert Medical School of Brown University HODE SLAND Eli Y. Adashi, MD, Dean of Medicine R I & Biological Science PUBLICATION OF THE RHODE ISLAND MEDICAL SOCIETY Rhode Island Department of Health David R. Gifford, MD, MPH, Director COMMENTARIES Quality Partners of Rhode Island Richard W. Besdine, MD, Chief 298 Feudalism or Futilism: Another Modest Proposal Medical Officer Joseph H. Friedman, MD Rhode Island Medical Society 299 A Sovereign Called Malaria: Humanity’s Lethal Companion Barry W. Wall, MD, President Stanley M. Aronson, MD EDITORIAL STAFF Joseph H. Friedman, MD CONTRIBUTIONS Editor-in-Chief Joan M. Retsinas, PhD SPECIAL CME ISSUE: Vaccination Managing Editor Guest Editors: Anne S. De Groot, MD, and Leonard Moise, PhD Stanley M. Aronson, MD, MPH Editor Emeritus 300 Vaccine Renaissance – From Basic Research to Implementation Anne S. De Groot, MD, and Leonard Moise, PhD EDITORIAL BOARD Stanley M. Aronson, MD, MPH 301 Progress Towards a Genome-derived, Epitope-driven Vaccine for Jay S. Buechner, PhD Latent TB Infection John J. Cronan, MD Leonard Moise, PhD, Julie McMurry, MPH, Daniel S. Rivera, James P. Crowley, MD E. Jane Carter, MD, Jinhee Lee, DVM, PhD, Hardy Kornfeld, MD, Edward R. Feller, MD William D. Martin, and Anne S. De Groot, MD John P. Fulton, PhD Peter A. Hollmann, MD 304 The New HPV Vaccine and the Prevention of Cervical Cancer Sharon L. Marable, MD, MPH Michael Steller, MD Anthony E. Mega, MD Marguerite A. -
HIV Vaccine Trials Network: Activities and Achievements of the First Decade and Beyond
For reprint orders, please contact [email protected] Research Update HIV Vaccine Trials Network: activities and achievements of the first decade and beyond Clin. Invest. (2012) 2(3), 245–254 The HIV Vaccine Trials Network (HVTN) is an international collaboration of James G Kublin*1, Cecilia A Morgan1, scientists and educators facilitating the development of HIV/AIDS preventive Tracey A Day1, Peter B Gilbert2, vaccines. The HVTN conducts all phases of clinical trials, from evaluating Steve G Self2, M Juliana McElrath1 experimental vaccines for safety and immunogenicity, to testing vaccine & Lawrence Corey3 efficacy. Over the past decade, the HVTN has aimed to improve the process 1HIV Vaccine Trials Network, Vaccine & Infectious of designing, implementing and analyzing vaccine trials. Several major Disease Institute, Fred Hutchinson Cancer achievements include streamlining protocol development while maintaining Research Center, 1100 Fairview Ave North, input from diverse stakeholders, establishing a laboratory program with Seattle, WA 98109, USA 2Statistical Center for HIV/AIDS Research & standardized assays and systems allowing for reliable immunogenicity Prevention, Vaccine & Infectious Disease assessments across trials, setting statistical standards for the field and Institute, Fred Hutchinson Cancer Research actively engaging with site communities. These achievements have allowed Center, 1100 Fairview Ave North, Seattle, the HVTN to conduct over 50 clinical trials and make numerous scientific WA 98109, USA 3 contributions to the field. Fred Hutchinson Cancer Research Center, 1100 Fairview Ave North, Seattle, WA 98109, USA *Author for correspondence: Keywords: clinical trial network • HIV • HIV Vaccine Trials Network • vaccine Tel.: +1 206 667 1970 E-mail: [email protected] Network mission The HIV Vaccine Trials Network (HVTN) is an international collaboration of scien- tists, educators and community members whose mission it is to enhance discovery and drive development of a safe and globally effective vaccine to prevent HIV. -
Paper Series
NBER WORKING PAPER SERIES THE REPEATED SETBACKS OF HIV VACCINE DEVELOPMENT LAID THE GROUNDWORK FOR SARS-COV-2 VACCINES Jeffrey E. Harris Working Paper 28587 http://www.nber.org/papers/w28587 NATIONAL BUREAU OF ECONOMIC RESEARCH 1050 Massachusetts Avenue Cambridge, MA 02138 March 2021 The opinions expressed here are solely those of the author and do not represent the views of the Massachusetts Institute of Technology, Eisner Health, the National Bureau of Economic Research, or any other individual or organization. The author has no sources of research support to declare. The author has received no direct or indirect remuneration for this article. The author discloses that a family member, M. Scott Harris MD, is chief medical officer of Altimmune, a biopharmaceutical company with two COVID-19 vaccine prototypes currently in development. The author has no financial or other interests in Altimmune’s products, and no one employed by or affiliated with Altimmune had any part in drafting or reviewing this article. Otherwise, the author has no actual or potential conflicts of interest to declare. NBER working papers are circulated for discussion and comment purposes. They have not been peer-reviewed or been subject to the review by the NBER Board of Directors that accompanies official NBER publications. © 2021 by Jeffrey E. Harris. All rights reserved. Short sections of text, not to exceed two paragraphs, may be quoted without explicit permission provided that full credit, including © notice, is given to the source. The Repeated Setbacks of HIV Vaccine Development Laid the Groundwork for SARS-CoV-2 Vaccines Jeffrey E. Harris NBER Working Paper No.