🏛️ Verified NIH Record • Updated 2026-07-13

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1 (NCT07390955)

A Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and in Vitro Neutralization of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS Administered in Multiple Doses and Routes to Adult Participants Without HIV-1

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

🩺 Plain-English Summary (8th-Grade Level)

This study is testing a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. Researchers will give it by vein (IV) and under the skin (SC), both on its own and together with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. They will assess safety and side effects, determine the right dose, study how the body processes the drug (pharmacokinetics or PK), and measure how well it neutralizes HIV in the blood (serum neutralizing activity). The expectation is that ePGT121v1-LS, whether given alone or with PGDM1400LS and VRC07-523LS, by IV or SC, will be safe in generally healthy adults and that the antibodies will not interfere with each other when used together. Approximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B). Part A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg/kg, 20 mg/kg, or 40 mg/kg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits. Part B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks apart and will receive three antibodies as SC shots in this order: first ePGT121v1-LS (125 mg), then PGDM1400LS (100 mg), and then VRC07-523LS (100 mg). The total study duration for participants in Part B is 24 weeks of scheduled clinic visits.

Who can join: Review the eligibility criteria below.

Location: Alabama CRS (Site ID: 31788) — Birmingham, Alabama

Age range: 18 Years to 55 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (11 Sites)

  • Alabama CRS (Site ID: 31788) — Birmingham, Alabama
  • Bridge HIV CRS (Site ID: 30305) — San Francisco, California
  • The Ponce de Leon Center CRS (Site ID: 5802) — Atlanta, Georgia
  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007) — Boston, Massachusetts
  • Penn Prevention CRS (Site ID: 30310) — Philadelphia, Pennsylvania
  • Vanderbilt Vaccine (VV) CRS (Site ID: 30352) — Nashville, Tennessee
  • Houston Advancing Research Team CRS (Site ID: 31473) — Houston, Texas
  • Via Libre CRS (Site ID: 31909) — Lima Cercado, Lima region
  • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970) — Bellavista, Provincia Constitucional del Callao
  • Seke South CRS (Site ID: 30294) — Harare,
  • Spilhaus CRS (Site ID: 30314) — Harare,

📞 Contact the Study Coordinator

Phone: (205) 873-8686

Email: heatherlogan@uabmc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in HIV

Explore by condition: All HIV clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗