Results
ADVERSE EVENTS, ADVERSE EVENT, MAY, ADVERSE EVENT, PLAQUE
Between Jan 29 and May 17, 2019, 303 participants were screened, 53 were ineligible, and 250 were enrolled and randomly assigned to the standard dose (n=124) or the fractional dose (n=126; Study profile*Reasons are not mutually exclusive.The primary per-protocol analysis included 117 participants in the fractional dose group and 117 in the standard dose group (94% of participants). Exclusions from the per-protocol population were related to having detectable PRNTThe median age at enrolment was 36 years (IQR 28–45) and 129 (52%) were female (Baseline characteristicsData are n (%) unless otherwise specified. All participants were stage 1 HIV WHO clinical stage.Defined as 50% plaque reduction neutralisation test ≥10.28 days after vaccination, 112 (96%, 95% CI 90–99) of 117 participants in the fractional dose group and 115 (98%, 94–100) of 117 in the standard dose group seroconverted by PRNTImmunological outcomes in the per-protocol populationSeroconversion is defined as ≥4-fold increase in neutralising antibody titre at each timepoint from baseline.Seroconversion Difference=Fractional–Standard.Geometric mean titre ratio=Fractional ÷ Standard.Non-inferiority of seroconversion of fractional doses compared with standard doseAt 28 days, the GMT was 1391 (958–2019) in the fractional dose group and 1613 (1163–2236) in the standard dose group and GMFI was 278 (192–404) and 323 (233–447; 110 participants reported at least one adverse event occurring within the 28 days following vaccination. 49 (39%) of 126 participants in the fractional dose group and 61 (49%) of 124 in the standard dose group had an adverse event, accounting for a total of 187 adverse events. There were no adverse events immediately after vaccination. 18 (14%) of 126 participants in the fractional dose group and 33 (27%) of 124 in the standard dose group were classified as having an adverse event related to the study vaccine (Adverse events up to 28 days after vaccination and serious adverse events throughout follow-upData are n (%).