Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults
Trial Parameters
Brief Summary
This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for participation: 1. Male or female, aged 18 to 50 years, inclusive, at the time of enrollment 2. Willing and able to read, sign, and date the informed consent form 3. Demonstrates an understanding of the study with a passing score (90% or greater) on the TOU by the third attempt, before study-related procedures are performed 4. Willing and able to comply with study requirements and be available to attend visits for the duration of study participation 5. Must have the means to be contacted by telephone for the duration of study participation 6. Willing to have photo or fingerprint taken for identification purposes 7. At low risk for HIV acquisition per investigator assessment 8. Agrees to refrain from donating blood or plasma outside of this study for at least the duration of study participation 9. Healthy based on the physician investigator's clinical judgment after review of past medical history,