Associations between gender and solicited adverse events after passive infusion of VRC01 or placebo in HVTN 704/HPTN 085

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Background: Realizing the potential of HIV prevention options requires understanding product tolerability across diverse groups vulnerable to HIV acquisition. Gender minority (GM) individuals are understudied in clinical trials. Setting: HVTN 704/HPTN 085, a phase 2b randomized HIV prevention trial, enrolled MSM and transgender participants from Brazil, Peru, Switzerland, and the US to receive an infusion every 8 weeks (10 total) of VRC01 30mg/kg, VRC01 10mg/kg, or placebo. Solicited adverse events (AEs) were recorded for 3 days after each infusion. Methods: Gender was defined by self-report and sex assigned-at-birth. Multivariate mixed logistic models were employed to estimate the association between gender (cisgender men [CM] vs. GM participants [transgender women, transgender men, or another gender]) and solicited AE frequency and severity. Results: GM participants reported more solicited AEs than CM among all participants (adjusted OR 1.59, 95%CI 1.20-2.10, p=0.001) and among placebo recipients (1.72, 1.05-2.81, p=0.031). The severity of solicited AEs (occurrence of ≥Grade 2 event) did not significantly differ overall (1.83, 0.79-4.20, p=0.174) or among placebo recipients (3.05, 0.76-12.32, p=0.112). Grade 2 events were reported after 1% and 2% of total infusions among CM and GM participants, respectively. Grade 3-4 events were rare overall (<0.1%). Completion of 10 infusions was high (78.6%) and slightly higher in CM (79.2%) than GM participants (73%). Conclusion: This is the first report of associations between gender and solicited AEs following monoclonal antibody infusion. GM participants reported more events; severity was low. HIV prevention trials must engage and support GM individuals to best evaluate tolerability of novel agents.