Phase 1 Study to Assess Safety and Immune Response of Ad26.Mos4.HIV and CH505 TF chTrimer Vaccine Combination in Healthy Adults Aged 18 to 50

What this Trial Is About

Researchers are studying a Phase I clinical trial to evaluate the safety and immune response of two different dosing schedules of the Ad26.Mos4.HIV and CH505 TF chTrimer vaccine combination in healthy adults aged 18 to 50 years who have a low risk of HIV infection. The trial is randomized, double-blind, and placebo-controlled, aiming to compare a rapid dose-escalating vaccination schedule with a dose-consistent schedule. This study is exploring how well these vaccination regimens mimic acute HIV viral replication and their effects on immune markers. Participants will be divided into four study groups receiving different combinations and dosing schedules of the vaccines and placebo. Some groups receive consistent doses of Ad26.Mos4.HIV and CH505 TF chTrimerALFQ on specific study days, while others receive lower initial doses followed by rapid dose escalations before consistent doses later. Injections are given intramuscularly into the same thigh muscle on scheduled days across a timeline up to 169 days. Optional lymph node biopsies may be performed on Day 71 for consenting participants. During the study, participants will attend multiple visits for injections and monitoring for up to 18 months. Researchers will assess the occurrence and severity of local and systemic side effects, serious adverse events, and specific adverse events of interest from Day 0 to Day 505. Immune responses will be measured by antibody levels targeting HIV envelope proteins at various visits throughout the study. Safety monitoring includes sentinel groups with early safety reviews before expanding enrollment. Participants are expected to comply with study requirements and follow-up visits throughout the trial.

Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults