Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial

Annals of Internal Medicine
Lindsey R BadenB003-IPCAVD004-HVTN091 Study Group

Abstract

A prophylactic HIV-1 vaccine is a global health priority. To assess a novel vaccine platform as a prophylactic HIV-1 regimen. Randomized, double-blind, placebo-controlled trial. Both participants and study personnel were blinded to treatment allocation. (ClinicalTrials.gov: NCT01215149). United States, East Africa, and South Africa. Healthy adults without HIV infection. 2 HIV-1 vaccines (adenovirus serotype 26 with an HIV-1 envelope A insert [Ad26.EnvA] and adenovirus serotype 35 with an HIV-1 envelope A insert [Ad35.Env], both administered at a dose of 5 × 1010 viral particles) in homologous and heterologous combinations. Safety and immunogenicity and the effect of baseline vector immunity. 217 participants received at least 1 vaccination, and 210 (>96%) completed follow-up. No vaccine-associated serious adverse events occurred. All regimens were generally well-tolerated. All regimens elicited humoral and cellular immune responses in nearly all participants. Preexisting Ad26- or Ad35-neutralizing antibody titers had no effect on vaccine safety and little effect on immunogenicity. In both homologous and heterologous regimens, the second vaccination significantly increased EnvA antibody titers (approximately 20-fold from the med...Continue Reading

Citations

Mar 11, 2017·Human Vaccines & Immunotherapeutics·Denise C Hsu, Robert J O'Connell
Mar 23, 2017·Proceedings of the National Academy of Sciences of the United States of America·Jan MedlockAlison P Galvani
Dec 16, 2017·MSphere·Quazim A AlayoPablo Penaloza-MacMaster
Sep 5, 2017·Immunology·Ian R Humphreys, Sarah Sebastian
Nov 14, 2018·The Journal of Clinical Investigation·Hongjie WangAndré Lieber
Jan 18, 2020·Expert Review of Vaccines·Punnee Pitisuttithum, Mary Anne Marovich
May 28, 2020·International Journal of Molecular Sciences·Ana RicobarazaRuben Hernandez-Alcoceba
Jun 21, 2018·Nature Reviews. Microbiology·Peter AbbinkDan H Barouch
Apr 29, 2020·Annual Review of Immunology·Kathryn E StephensonDan H Barouch
Apr 19, 2018·The Journal of Infectious Diseases·Lindsey R BadenUNKNOWN IPCAVD006/RV380/HIV-V-A002 Study Group
Aug 17, 2020·Archives of Virology·Fatima LaherGlenda E Gray
Aug 26, 2020·Expert Review of Clinical Pharmacology·Kimia KardaniAzam Bolhassani
Oct 24, 2020·PLoS Computational Biology·Emilio Dorigatti, Benjamin Schubert
Nov 12, 2020·BMJ Evidence-based Medicine·Eric A ApaydinSusanne Hempel
Jan 12, 2021·Advanced Drug Delivery Reviews·Jatin MachhiBhavesh D Kevadiya
Jan 31, 2021·Proceedings of the National Academy of Sciences of the United States of America·Dariusz K MurakowskiArup K Chakraborty
Jan 30, 2021·Open Forum Infectious Diseases·Karina OganezovaLindsey R Baden
Mar 8, 2021·Vaccine·Jerome CustersUNKNOWN Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG)
Jul 28, 2021·Communications Biology·Teresa LambeSarah C Gilbert
Sep 1, 2021·Expert Opinion on Drug Discovery·Cecilia BenazzatoPatricia Cristina Baleeiro Beltrão-Braga
Nov 23, 2021·Journal of the International AIDS Society·Jiae KimJulie A Ake

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