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
Male or female, aged 18 to 50 years, inclusive, at the time of enrollment
Willing and able to read, sign, and date the informed consent form
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
Willing and able to comply with study requirements and be available to attend visits for the duration of study participation
first diagnosed within the 12 weeks prior to screening; or
worsening in terms of clinical outcome in the 24 weeks prior to screening; or
involves the need for medication that may pose a risk to the participant's safety or impede assessment of adverse events or immunogenicity if they participate in the study.
Hemoglobin ≥11.0 g/dL for females; ≥12.5 g/dL for males
U.S. Army Medical Research and Development Command
Lead sponsor
Janssen Vaccines & Prevention B.V.
Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborator
Duke University
Collaborator
Walter Reed Army Institute of Research (WRAIR)
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Makerere University Walter Reed Project
Collaborator