Can antibodies shield newborns from HIV? early trial begins

NCT ID NCT06517693

Recruiting now Prevention Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This early-stage study is testing whether two lab-made antibodies, PGT121.414.LS and VRC07-523LS, are safe for newborns who were exposed to HIV during birth. The 48 infants will receive one or two shots of the antibodies under the skin. Researchers will monitor for side effects and measure how long the antibodies stay in the babies' blood. The goal is to see if this approach could one day help prevent HIV infection in at-risk infants.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: PGT121.414.LS and VRC07-523LS (HIV antibodies)
What this could lead to: If successful, this could lead to a way to protect HIV-exposed newborns from getting HIV, potentially preventing lifelong infection.
What could go wrong: This is a very early phase 1 safety study with only 48 infants, so it is not designed to prove effectiveness. The antibodies may not provide full protection, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1

Contacts and locations

Locations

Site 31890, Harare Family Care
NOT_YET_RECRUITING

Harare, Zimbabwe
Site 32513, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research Network CRS
NOT_YET_RECRUITING

San Juan, 00935, Puerto Rico
Site 5013, Jacobi Medical Center Bronx
NOT_YET_RECRUITING

The Bronx, New York, 10461, United States
Site 5030, Emory University School of Medicine
NOT_YET_RECRUITING

Atlanta, Georgia, 30322, United States
Site 5051, University of Florida Jacksonville
RECRUITING

Jacksonville, Florida, 32209, United States
Site 5052, University of Colorado Denver
RECRUITING

Aurora, Colorado, 80045, United States
Site 5072, Hospital Federal dos Servidores do Estado
NOT_YET_RECRUITING

Rio de Janeiro, CEP 20221-903, Brazil
Site 5083, Rush University Cook County Hospital Chicago
WITHDRAWN

Chicago, Illinois, 60612, United States
Site 5092, Johns Hopkins University Baltimore
RECRUITING

Baltimore, Maryland, 21287, United States
Site 5097, Hospital Geral De Nova Iguacu Brazil
NOT_YET_RECRUITING

Rio de Janeiro, CEP 26030-380, Brazil
Site 5112, David Geffen School of Medicine at UCLA
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
Site 5114, Bronx-Lebanon Hospital Center
RECRUITING

The Bronx, New York, 10457, United States
Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho
NOT_YET_RECRUITING

Kericho, 20200, Kenya
Site 5127, Pediatric Perinatal HIV
WITHDRAWN

Miami, Florida, 33136, United States
Site 5128, Baylor College of Medicine/Texas Children's Hospital
RECRUITING

Houston, Texas, 77030, United States
Site 6501, St. Jude Children's Research Hospital
NOT_YET_RECRUITING

Memphis, Tennessee, 38105, United States
Site 8950, FAMCRU
NOT_YET_RECRUITING

Cape Town, Parrow Valley, 7505, South Africa

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