Toward the next HIV vaccine efficacy trial
The CAPRISA Vaccine team under Dr Nigel Garrett and Dr Kathy Mngadi completed follow up to 29 participants in the APPROACH study, a randomized safety and immunogenicity trial, that enrolled 400 participants across sites in South Africa, Rwanda, Uganda, the United States, and Thailand.
The study was sponsored by Janssen Vaccines and Prevention B.V., and participants received four vaccinations over 48 weeks, two priming immunizations at months 0 and 3 with Ad26.Mos.HIV followed by two booster immunizations at months 6 and 12 with either Ad26 or MVA vectors and high or low dose trimeric clade C gp140 protein in alum adjuvant.
Results of APPROACH were presented at the International AIDS Society conference in Paris in July 2017. After the final boost, 80% or more of participants displayed the requisite immune responses at levels above the desired magnitude, greatly exceeding the targets set for making the go/no go decision about proceeding to efficacy testing. The efficacy tri-al, HVTN 705, is planned to start later in the year, and aims to enrol 2600 sexually active women aged 18 – 35, randomized 1:1 to receive either the active vaccine regimen or placebo. The CAPRISA team is proud to contribute to the trial, and Dr Mngadi will Co-Chair the study.