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: Concluded
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

Key Study Personnel

Oladapo Alli, DAIDS Pharmacist
Philip Andrew, LOC Clinical Research Manager
Wairimu Chege, DAIDS Medical Officer
Cynthia Gay, Protocol Chair
Carissa Karg, HVTN Clinical Trials Manager
Shelly Karuna, HVTN Clinical Trials Manager
Laura Polakowski, DAIDS Medical Officer
Stephen Walsh, Protocol Chair