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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.

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