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

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.

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

Yes

Interventions

• 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

Locations (22)