Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19)

Publication date: Available online 6 July 2018Source: The LancetAuthor(s): Dan H Barouch, Frank L Tomaka, Frank Wegmann, Daniel J Stieh, Galit Alter, Merlin L Robb, Nelson L Michael, Lauren Peter, Joseph P Nkolola, Erica N Borducchi, Abishek Chandrashekar, David Jetton, Kathryn E Stephenson, Wenjun Li, Bette Korber, Georgia D Tomaras, David C Montefiori, Glenda Gray, Nicole Frahm, M Juliana McElrathSummaryBackgroundMore than 1·8 million new cases of HIV-1 infection were diagnosed worldwide in 2016. No licensed prophylactic HIV-1 vaccine exists. A major limitation to date has been the lack of direct comparability between clinical trials and preclinical studies. We aimed to evaluate mosaic adenovirus serotype 26 (Ad26)-based HIV-1 vaccine candidates in parallel studies in humans and rhesus monkeys to define the optimal vaccine regimen to advance into clinical efficacy trials.MethodsWe conducted a multicentre, randomised, double-blind, placebo-controlled phase 1/2a trial (APPROACH). Participants were recruited from 12 clinics in east Africa, South Africa, Thailand, and the USA. We included healthy, HIV-1-uninfected participants (aged 18–50 years) who were considered at low risk for HIV-1 infection. We randomly assigned participants to one of eight study groups, stratified by region. Participants and investigators were blinded to the treatment allocation throughout the study. We primed participants at weeks 0 and 12 with Ad26.Mos.HIV (5 × 1010 viral particles per 0·5 mL)...
Source: The Lancet - Category: General Medicine Source Type: research