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A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-03-07
Completion Date
2027-09-15
Last Updated
2026-04-07
Healthy Volunteers
Yes
Conditions
Interventions
VRC07-523LS 400mg
Intravenous infusion (IV)
PGT121.414.LS 400mg
IV infusion
PGDM1400LS 400mg
IV infusion
VRC07-523LS 3200mg
IV infusion
PGT121.414.LS 1600mg
IV infusion
PGDM1400LS 1600mg
IV infusion
Locations (22)
Alabama CRA (Site #31788)
Birmingham, Alabama, United States
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States
The Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur, Georgia, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
Fenway Health
Boston, Massachusetts, United States
BIDMC VCRS (Site ID# 32077)
Boston, Massachusetts, United States
Columbia P&S CRS
New York, New York, United States
University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)
Rochester, New York, United States
Chapel Hill CRS (Site #3201)
Chapel Hill, North Carolina, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, United States
University of Pittsburgh CRS (Site 1001)
Pittsburgh, Pennsylvania, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS (Site ID# 30331)
Seattle, Washington, United States
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil
ACSA CRS
Iquitos, Maynas, Peru
CITBM CRS (Site ID 31970)
Callao, Peru
Via Libre (Site ID 31909)
Lima, Peru
San Miguel CRS (Site #11302)
Lima, Peru
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gaunteng, South Africa
Chatsworth CRS
Chatsworth, KwaZulu-Natal, South Africa
Setshaba Research Centre
Soshanguve-H, Soshanguve, South Africa
Groote Schuur HIV CRS
Cape Town, Western Cape, South Africa