Medical Writing Vaccines and Immunotherapies HIV vaccine clinical trials: An overview
mew-27-1png

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
Lingua Franca and Beyond
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

Member Login

Links

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

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: