HVTN 127/HPTN 087

A multicenter, randomized, partially blinded phase 1 clinical trial to evaluate the safety and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults.

Study Details

Protocol Status: Closed to Follow Up
Study Purpose:

A multicenter, randomized, partially blinded phase 1 clinical trial to evaluate the safety and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults.

Study Design:

Multicenter, randomized clinical trial.

Study Population:

Healthy, HIV-1–uninfected volunteers aged 18 to 50 years in the United States and Switzerland.

Study Size:

124 healthy, HIV-1–uninfected volunteers aged 18 to 50 years.

Study Duration:

26 months of scheduled clinic visits; 32 months total study duration (includes enrollment and follow-up)

Treatment Regimen:
Primary Objectives:

1. To evaluate the safety and tolerability of different doses of VRC07-523LS administered IV, SC, and IM by repeat dosing every 16 weeks for a total of 5 administrations to healthy adults
2. To evaluate the serum concentrations of VRC07-523LS administered IV, SC, and IM over a total of 6 regimens