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Safety and dosing of two long‑lasting HIV antibodies in newborns

Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1

Phase 1 Interventional National Institute of Allergy and Infectious Diseases (NIAID) · NCT06517693

This will try giving one or two long‑lasting HIV antibodies soon after birth to infants born to people with HIV to check safety and how long the antibodies stay in the baby's blood.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment48 (estimated)
AgesN/A to 72 Hours
SexAll
SponsorNational Institute of Allergy and Infectious Diseases (NIAID) NIH
Drugs / interventionsimmunotherapy
Locations17 sites (Los Angeles, California and 16 other locations)
Trial IDNCT06517693 on ClinicalTrials.gov

What this trial studies

This open‑label Phase 1 study gives the broadly neutralizing monoclonal antibody PGT121.414.LS alone or combined with VRC07-523LS by subcutaneous injection soon after birth to infants exposed to HIV‑1. Infants enrolled within 72 hours of birth receive one or two doses and are followed with blood tests to measure safety and antibody pharmacokinetics through Week 12 or Week 24. Eligible infants are term (≥36 weeks), weigh at least 2 kg at birth, and meet basic laboratory criteria before dosing. The trial is conducted at U.S. clinical sites with NIAID sponsorship and specialized pediatric monitoring.

Who should consider this trial

Good fit: Ideal candidates are infants born to a parent with confirmed HIV‑1 who are ≥36 weeks gestation, weigh at least 2 kg, are less than 72 hours old, and whose birthing parent can provide consent.

Not a fit: Infants born preterm (<36 weeks), under 2 kg, older than 72 hours at screening, or whose parent cannot consent are not eligible and would not receive benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a safe way to provide newborns immediate, passive protection against HIV using long‑lasting antibodies.

How similar studies have performed: Other broadly neutralizing HIV antibodies have shown safety and antiviral activity in early adult and some infant studies, but using this specific combination soon after birth remains early‑phase and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV-1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.