Medical Writing Vaccines and Immunotherapies HIV vaccine clinical trials: An overview

Volume 27, Issue 1 - Vaccines and Immunotherapies

HIV vaccine clinical trials: An overview

Abstract

More than 30 years after the discovery of the human immunodeficiency virus as the agent that causes AIDS, an effective vaccine against this deadly disease has yet to be developed. The pathway to the development of a vaccine has been riddled with challenges, many unique to HIV itself. As a result, advocates, scientists, and funders have had to move away from a “home run” philosophy that had anticipated early success. Nonetheless, much has been learned along the way about the genetic diversity of the virus, the limitations of animal studies, and the cultural infra structure and regulatory challenges involved in testing HIV vaccines. The application of coordinated approaches to face the difficulties outlined in this article is a logical way forward in developing a vaccine. Then even more progress can be made, in spite of all the uncertainties, toward the achievement of a successful vaccine.

Download the full article

References

  1. Hiv.gov. HIV Vaccines. 2017 [cited 2017 Nov 11]. Available from: https://www.hiv.gov/hiv-basics/hiv-prevention/potential-future-options/hiv-vaccines
  2. Kurth AE, Celum C, Baeten JM, Vermund SH, Wasserheit JN. Combination HIV prevention: significance, challenges, and opportunities. Current HIV/AIDS reports. 2011;8(1):62–72.
  3. Stover J, Bollinger L, Hecht R, Williams C, Roca E. The impact of an AIDS vaccine in developing countries: a new model and initial results. Health Aff. 2007;26(4):1147–58.
  4. Sheets RL, Zhou T, Knezevic I. Review of efficacy trials of HIV-1/AIDS vaccines and regulatory lessons learned: a review from a regulatory perspective. Biologicals. 2016;44(2):73–89.
  5. The History of Vaccines: An Educational Resource by The College of Physicians of Philadelphia. Vaccines for Sexually Transmitted Diseases. 2017 [cited 2017 Nov 11]. Available from: https://www. historyofvaccines.org/content/articles/ vaccines-sexually-transmitted-diseases
  6. Follmann D, Duerr A, Tabet S, Gilbert P, Moodie Z, Fast P, et al. J Acquir Immune Defic Syndr. 2007;44(1):49–60.
  7. HIV/AIDS vax - An IAVI Report Bulletin. Understanding Vaccine Trials: How are AIDS vaccines tested? 2003;1(1):4. Available from: http://www.vaxreport.org/vax-1-1-august- 2003/869-understanding-vaccine-trials.
  8. Esparza J. An HIV vaccine: how and when? Bull World Health Organ. 2001;79(12):1133–7.
  9. The History of Vaccines: An Educational Resource by The College of Physicians of Philadelphia. Vaccine Development, Testing, and Regulation. 2017 [cited 2017 Nov 04] Available from: https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation
  10. Black S. The costs and effectiveness of large Phase III pre-licensure vaccine clinical trials. Expert Rev Vaccines. 2015;14(12):1543–8.
  11. Wu X, Wang C, O’Dell S, Li Y, Keele BF, Yang Z, et al. Selection pressure on HIV-1 envelope by broadly neutralizing antibodies to the conserved CD4-binding site. J Virol. 2012;86(10):5844–56.
  12. AMP Study. About AMP: What is the AMP Study? 2017 [cited 2017 Nov 30]. Available from: https://ampstudy.org.za/about
  13. U.S. Military HIV Research Program. RV144 Trial. 2017 [cited 2017 Dec 02]. Available from: https://www.hivresearch.org/rv144-trial
  14. Uhambo: A Journey of Hope to Prevent HIV. What is HVTN 702? 2017 [cited 2017 Nov 30]. Available from: http://www.uhambo.org.za/about
  15. Imbokodo: Stand up to HIV. What is Imbokodo? 2017 [cited 2017 Nov 30]. Available from: https://www.imbokodo.org.za/about
  16. Vardas E, Buttò S, Glashoff R, Malnati MS, Poli G, Clerici M. Preparing for phase II/III HIV vaccine trials in Africa. Microbes Infect. 2005;7(14):1436–44.
  17. UNAIDS Guidance Document: Ethical considerations in HIV preventive vaccine research. 2000
  18. Scientific considerations for the regulation and clinical evaluation of HIV/AIDS preventive vaccines: report from a WHOUNAIDS Consultation 13-15 March 2001, Geneva, Switzerland. AIDS. 2002;16(10):W15–25.
  19. Okpokoro E, Osawe S, Datong P, Yakubu A, Ukpong M, Orhii P, et al. Preparing for HIV vaccine trials in Nigeria: building the capacity of the community and national coordinating, regulatory and ethical bodies. J AIDS Clin Res. 2013;4(12):260.
  20. National Institute of Environmental Health Sciences. Institutional Biosafety Committee. 2017 [cited 2017 Dec 03]. Available from: https://www.niehs.nih.gov/about/boards/ibc/index.cfm
  21. Department of Agriculture, Forestry and Fisheries: Republic of South Africa. Biosafety Notifications. 2017 [cited 2017 Dec 03]. Available from: http://www.daff.gov.za/daffweb3/Branches/Agricultural-Production-Health-Food-Safety/Genetic-Resources/Biosafety/Biosafety-Clearing-House
  22. Barouch DH, Picker LJ. Novel vaccine vectors for HIV-1. Nat Rev Microbiol. 2014;12(11):765–71.
  23. Excler JL, Michael NL. Lessons from HIV- 1 vaccine efficacy trials. Curr Opin HIV AIDS. 2016;11(6):607–13.
  24. HIV Vaccine Trials Network. Getting the Right Test for HIV. [cited 2017 Nov 30]. Available from: http://www.hvtn.org/en/participants/visp-hiv-testing.html

Search

Articles

Vaccines and immunotherapies
President's Column
A history of EMWA
EMWA News
An introduction to vaccines and immunotherapies
Immuno-oncology: Harnessing our immune system to fight cancer
Changing methods to assess targeted therapies in oncology
HIV vaccine clinical trials: An overview
Allergen immunotherapy in the European regulatory environment
Pharmacovigilance for vaccines and immunotherapies
Addressing vaccine hesitancy in writing
Results of the 2017 EMWA salary survey
Lay writing: Strategies for improving assent forms
The perils of the unknown: Missing data in clinical studies
Medical writing in China: Trends and opportunities
PhD student: A medical writer in the making!
News from the EMA
Medical Communications
Journal Watch
In the Bookstores
The Webscout
Teaching Medical Writing
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Entering medical communications as a non-native English speaker
Out on Our Own
Lingua Franca and Beyond

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk