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Can antibodies shield newborns from HIV? early trial begins

NCT ID NCT06517693

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 4 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 72 hours

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for themselves and permission for their infant's participation in this study. * Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes. * Infant was singleton or twin. * Infant's gestational age at birth was at least 36 weeks. * At birth, infant's weight was at least 2 kg. * At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth. * At screening, infant has the following laboratory test results: * Hemoglobin, normal or grade 1 (≥13 g/dL or ≥8.05 mmol/L) * Platelets, normal or grade 1 (≥100,000 cells/mm3 or ≥100.000 x10\^9 cells/L) * Absolute neutrophil count (ANC), normal or grade 1 1. ≤24 hours old (≥4,000 cells/mm3 or ≥4.000 x10\^9 cells/L) 2. \>24 hours old (≥1,250 cells/mm3 or ≥1.250 x10\^9 cells/L) * Alanine transaminase (ALT), normal (\<1.25 x ULN) * At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings. * Cohorts 1 and 2, Strata BF only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding. * Cohorts 1 and 2, Strata FF, only: At entry, infant is not breastfeeding and the birthing parent has indicated no intention to breastfeed. * At entry, infant is at increased risk of HIV acquisition. Cohorts 1 and 2, Strata FF only: * Birthing parent had acute HIV during this pregnancy; or * Birthing parent with detectable viral replication (plasma HIV RNA results at least 50 copies/mL) during pregnancy who did not have confirmed viral suppression, defined as at least two consecutive plasma HIV RNA results less than 50 copies/mL from specimens obtained at least four weeks apart with the latest result within four weeks prior to delivery; or * Birthing parent not receiving appropriate ART for at least two weeks, with any part of the two-week period occurring within four weeks prior to delivery, based on birthing parent's report or available medical records. Cohorts 1 and 2, BF only: * Per birthing parent's report, intends to breastfeed Exclusion Criteria: * Birthing parent has received any investigational product during this pregnancy. * Infant has received any active or passive HIV immunotherapy or any investigational product. * At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result. * Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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, Puerto Rico, 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

    WITHDRAWN

    Rio de Janeiro, Brazil, 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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