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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Site 5052, University of Colorado Denver NICHD CRS
  Aurora, Colorado, United States Recruiting
• Site 5051, University of Florida Jacksonville NICHD CRS
  Jacksonville, Florida, United States Recruiting
• Site 5092, Johns Hopkins University Baltimore
  Baltimore, Maryland, United States Recruiting
• Site 5114, Bronx-Lebanon Hospital Center
  The Bronx, New York, United States Recruiting
• Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS
  Houston, Texas, United States Recruiting
• Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho CRS
  Kericho, Kenya Recruiting

Study contacts

• Study coordinator: Emily Brown
• Email: embrown@fhi360.org
• Phone: 919-321-3806

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.