First-in-human phase 1 trial of the safety and immunogenicity of a recombinant adenovirus serotype 5 HVR48 (rAd5HVR48) HIV-1 vaccine

Methods Recombinant Ad5 with seven HVRs derived from Ad48 and expressing the VRC EnvA test antigen (rAd5HVR48. ENVA) was made. 48 healthy volunteers who were seronegative to Ad5, Ad48, HIV-1, and HIV-2 were enrolled in a randomized, double-blind, placebo-controlled, doseescalation phase 1 study. The first three groups of 12 subjects received doses of 10, 10, or 10 vp of rAd5HVR48.ENVA vector (n=10/group) or placebo (n=2/ group) at weeks 0, 4, and 24 and the fourth group received a single injection of 10 vp or placebo. We performed pre-specified blinded immunogenicity analyses at day 56 and day 196 after the first immunization.