Recruiting
Phase 1

PGT121.414.LS & VRC07-523LS

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT06517693

Conditions

HIV-1

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

PGT121.414.LS

VRC07-523LS

Study Details

Brief summary:

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.

Conditions

HIV-1

Study ID

NCT06517693

Start date

Jan 5, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cohort 1 Stratum Formula Fed (FF)

Single subcutaneous (SC) dose of PGT121.414.LS at birth, based on weight.

experimental: Cohort 1 Stratum Breastfed (BF)

Initial SC dose of PGT121.414.LS at birth, based on weight. Second SC dose of 100 mg PGT121.414.LS at Week 12, if still breastfeeding. Dosing at Week 12 is not based on weight.

experimental: Cohort 2 Stratum FF

Single SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight.

experimental: Cohort 2 Stratum BF

Initial SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight. Second SC doses of 100 mg of PGT121.414.LS and 100 mg VRC07-523LS at Week 12, if still breastfeeding. Dosing at Week 12 is not based on weight.

Interventions

PGT121.414.LS

Administered SC in the thigh

VRC07-523LS

Administered SC in the thigh

Primary outcome measure

  • Proportion of infants with at least one Grade 3 or higher Adverse Event (AE) (one dose) [ Time Frame: Day 0 through Week 12 ]
  • Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product (one dose) [ Time Frame: Day 0 through Week 12 ]
  • Proportion of infants with at least one Grade 3 or higher AE (two doses) [ Time Frame: Day 0 through Week 24 ]
  • Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product (two doses) [ Time Frame: Day 0 through Week 24 ]
  • PGT121.414.LS maximum concentration (Cmax) (single/first dose) [ Time Frame: Day 0 through Week 48 ]
  • PGT121.414.LS time of maximum concentration (Tmax) (single/first dose) [ Time Frame: Day 0 through Week 48 ]
  • PGT121.414.LS area under the curve (AUC(0-12WK)) (single/first dose) [ Time Frame: Day 0 through Week 12 ]
  • PGT121.414.LS concentration at the end of the first dose interval (C(12WK)) (single/first dose) [ Time Frame: Week 12 ]
  • PGT121.414.LS concentration at the end of the second dose interval (C(24WK)) (two doses) [ Time Frame: Week 24 ]
  • VRC07-523LS maximum concentration (Cmax) (single/first dose) [ Time Frame: Day 0 through Week 48 ]
  • VRC07-523LS time of maximum concentration (Tmax) (single/first dose) [ Time Frame: Day 0 through Week 48 ]
  • VRC07-523LS area under the curve (AUC(0-12WK)) [ Time Frame: Day 0 through Week 12 ]
  • VRC07-523LS concentration at the end of the first dose interval (C(12WK)) single/first dose) [ Time Frame: Week 12 ]
  • VRC07-523LS concentration at the end of the second dose interval (C(24WK)) (two doses) [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Emily Brown

919-321-3806embrown@fhi360.org

Locations

Site 5052, University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Site 5051, University of Florida Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Site 5092, Johns Hopkins University Baltimore

Recruiting

Baltimore, Maryland, United States, 21287

Site 5114, Bronx-Lebanon Hospital Center

Recruiting

The Bronx, New York, United States, 10457

Site 5128, Baylor College of Medicine/Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-08-25.