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.
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Study Documents
HVTN 127/HPTN 087 Version 2.0
- HVTN 127/HPTN 087 Protocol V2.0 - 8 March 2018
- HVTN 127/HPTN 087 Protocol V2.0, Full Protocol Amendment #1 – 8 March 2018
- HVTN 127/HPTN 087 Protocol V2.0, Clarification Memo #2 - 30 March 2020
- HVTN 127/HPTN 087 Protocol V2.0, Clarification Memo #1 - 4 April 2018
HVTN 127/HPTN 087 Version 1.0
Study Details
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.
Multicenter, randomized clinical trial.
Healthy, HIV-1–uninfected volunteers aged 18 to 50 years in the United States and Switzerland.
124 healthy, HIV-1–uninfected volunteers aged 18 to 50 years.
26 months of scheduled clinic visits; 32 months total study duration (includes enrollment and follow-up)
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