NCT06812494

A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
BIOLOGICAL	VRC07-523LS 400mg	Intravenous infusion (IV)
BIOLOGICAL	PGT121.414.LS 400mg	IV infusion
BIOLOGICAL	PGDM1400LS 400mg	IV infusion
BIOLOGICAL	VRC07-523LS 3200mg	IV infusion
BIOLOGICAL	PGT121.414.LS 1600mg	IV infusion
BIOLOGICAL	PGDM1400LS 1600mg	IV infusion

Timeline

• Start date: 2025-03-07
• Primary completion: 2027-01-15
• Completion: 2027-09-15
• First posted: 2025-02-06
• Last updated: 2026-04-07

Locations

22 sites across 4 countries: United States, Brazil, Peru, South Africa

Regulatory

• FDA-regulated drug study