A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study ID
- NCT06812494
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- VRC07-523LS 400mg — BIOLOGICALIntravenous infusion (IV)
- PGT121.414.LS 400mg — BIOLOGICALIV infusion
- PGDM1400LS 400mg — BIOLOGICALIV infusion
- VRC07-523LS 3200mg — BIOLOGICALIV infusion
- PGT121.414.LS 1600mg — BIOLOGICALIV infusion
- PGDM1400LS 1600mg — BIOLOGICALIV infusion
Study Details
HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.
Key Dates
- Start date
- Mar 7, 2025
- Status verified
- Apr 2026
- Primary completion
- Jan 15, 2027
- Completion
- Sep 15, 2027
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Group 1 (400 mg + 400 mg +400 mg)VRC07-523LS 400mg + PGT121.414.LS 400mg + PGDM1400LS 400mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
- Experimental: Group 2 (3200 mg + 1600 mg +1600 mg)VRC07-523LS 3200mg + PGT121.414.LS 1600mg + PGDM1400LS 1600mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
Primary Outcome Measure
Number of participants experiencing local Adverse Events (AEs) [ Time Frame: At Days 1, 4, 7, 169 and 173 ]
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Alabama CRA (Site #31788) | Birmingham | Alabama | 35222 | |
| Bridge HIV, San Francisco Department of Public Health | San Francisco | California | 94102 | |
| The Hope Clinic of the Emory Vaccine Research Center; Emory University | Decatur | Georgia | 30030 | |
| BIDMC VCRS (Site ID# 32077) | Boston | Massachusetts | 02215 | |
| Brigham and Women's Hospital Vaccine CRS (BWH VCRS) | Boston | Massachusetts | 02115-6110 | |
| Fenway Health | Boston | Massachusetts | 02215-4302 | |
| Columbia P&S CRS | New York | New York | 10032 | |
| University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467) | Rochester | New York | 14642 | |
| Chapel Hill CRS (Site #3201) | Chapel Hill | North Carolina | 27599 | |
| Penn Prevention CRS | Philadelphia | Pennsylvania | 19104 | |
| University of Pittsburgh CRS (Site 1001) | Pittsburgh | Pennsylvania | 15213 | |
| Vanderbilt Vaccine (VV) CRS | Nashville | Tennessee | 37232 | |
| Seattle Vaccine and Prevention CRS (Site ID# 30331) | Seattle | Washington | 98104 |
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