Review of efficacy trials of HIV-1/AIDS vaccines and regulatory lessons learned: A review from a regulatory perspective

Biologicals : Journal of the International Association of Biological Standardization
Rebecca L SheetsIvana Knezevic

Abstract

The clinical development of prophylactic HIV-1/AIDS vaccines is confounded by numerous scientific challenges and these in turn result in challenges to regulators reviewing clinical trial applications (CTAs). The search for an HIV-1/AIDS vaccine will only succeed through the conduct of well-designed, well-conducted and well-controlled human efficacy studies. This review summarizes relevant context in which HIV vaccines are being investigated and the six completed efficacy trials of various candidate vaccines and regimens, as well as the lessons learned from them relevant to regulatory evaluation. A companion review focuses on the scientific challenges regulators face and summarizes some current candidates in development. The lessons learned from the completed efficacy trials will enable the development of better designed, potentially more efficient efficacy trials in future. This summary, supported by the World Health Organization (WHO), is unique in that it is meant to aid regulators in understanding the valuable lessons gained from experience in the field to date.

References

Mar 9, 2006·Current HIV/AIDS Reports·Isaac R Rodriguez-ChavezM Patricia D'Souza
Nov 17, 2006·The Journal of Infectious Diseases·Punnee PitisuttithumUNKNOWN Bangkok Vaccine Evaluation Group
Oct 22, 2009·The New England Journal of Medicine·Supachai Rerks-NgarmUNKNOWN MOPH-TAVEG Investigators
Apr 6, 2012·The New England Journal of Medicine·Barton F HaynesJerome H Kim
Mar 5, 2013·Current HIV/AIDS Reports·Sten H Vermund, Richard J Hayes
Oct 9, 2013·The New England Journal of Medicine·Scott M HammerUNKNOWN HVTN 505 Study Team
Feb 7, 2014·The New England Journal of Medicine·Anthony S Fauci, Hilary D Marston
Apr 5, 2014·Science·Anthony S FauciSusan P Buchbinder
Oct 24, 2014·Annual Review of Medicine·Jerome H KimNelson L Michael

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Citations

Apr 20, 2018·International Journal of Molecular Sciences·Maria TrovatoPiergiuseppe De Berardinis
Feb 23, 2019·Expert Review of Vaccines·Claudio CounoupasWarwick J Britton
Aug 20, 2016·APMIS : Acta Pathologica, Microbiologica, Et Immunologica Scandinavica·Muhammad ImranAhmed Bilal Waqar
May 6, 2020·Viral Immunology·Rhiannon R PenkertJulia L Hurwitz
Oct 7, 2017·Journal of Chemical Technology and Biotechnology·Nanxi WangJiantao Guo
Sep 20, 2020·Advances in Colloid and Interface Science·Abdur RehmanSohail Khan

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