A Phase 1 interventional study of PGT121.414.LS and VRC07-523LS in HIV-1, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 19 sites in 6 countries. Open to participants aged Up to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
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.
This is an open-label, phase I study of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS administered soon after birth in infants exposed to HIV-1. The study is designed to assess the safety and pharmacokinetics (PK) profile of one and two subcutaneous (SC) doses of PGT121.414.LS alone or in combination with VRC07-523LS through Week 12 and Week 24, respectively.
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At screening, infant has the following laboratory test results:
(ANC), normal or grade 1
Cohorts 1 and 2, Strata FF only:
Cohorts 1 and 2, BF only:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single subcutaneous (SC) dose of PGT121.414.LS at birth, based on weight.
Drug: PGT121.414.LS
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.
Drug: PGT121.414.LS
Single SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight.
Drug: PGT121.414.LS · Drug: VRC07-523LS
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.
Drug: PGT121.414.LS · Drug: VRC07-523LS
Administered SC in the thigh
Administered SC in the thigh
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
Proportion of infants with at least one Grade 3 or higher AE
Time frame: Day 0 through Week 96
Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product
Time frame: Day 0 through Week 96
Proportion of infants with at least one Grade 2 or higher AE (one dose)
Time frame: Day 0 through Week 12
Proportion of infants with at least one Grade 2 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 2 or higher AE (two doses)
Time frame: Day 0 through Week 24
Proportion of infants with at least one Grade 2 or higher AE assessed as related to study product (two doses)
Time frame: Day 0 through Week 24
Proportion of infants with any AEs that lead to study product discontinuation
Time frame: Day 0 through Week 12
PGT121.414.LS AUC(0-48WK) after single dose administration
Time frame: Week 48
PGT121.414.LS concentration after single dose administration
Time frame: Week 48
PGT121.414.LS concentration after two dose administration
Time frame: Week 60
PGT121.414.LS apparent clearance (CL/F)
Time frame: Day 0 through Week 60
PGT121.414.LS half-life (T1/2) following single dose administration
Time frame: Day 0 through Week 48
PGT121.414.LS half-life (T1/2) following two dose administration
Time frame: Day 0 through Week 60
VRC07-523LS AUC(0-48WK) after single dose administration
Time frame: Week 48
VRC07-523LS concentration after single dose administration
Time frame: Week 48
VRC07-523LS concentration after two dose administration
Time frame: Week 60
VRC07-523LS apparent clearance (CL/F)
Time frame: Day 0 through Week 60
VRC07-523LS half-life (T1/2) following single dose administration
Time frame: Day 0 through Week 48
VRC07-523LS half-life (T1/2) following tow dose administration
Time frame: Day 0 through Week 60
Proportion of infants with PGT121.414.LS concentrations > 20 and > 50 mcg/mL following single/first dose administration
Time frame: Week 12
Proportion of infants with PGT121.414.LS concentrations > 20 and > 50 mcg/mL following two dose administration
Time frame: Week 24
Proportion of infants with VRC07-523LS concentrations > 10 and > 20 mcg/mL following single/first dose administration
Time frame: Week 12
Proportion of infants with PGT121.414.LS concentrations > 10 and > 20 mcg/mL following two dose administration
Time frame: Week 24
Proportion of infants with anti-PGT121.414.LS antibodies detected
Time frame: Week 24
Proportion of infants with anti-VRC07-523LS antibodies detected
Time frame: Week 24
Proportion of infants with anti-PGT121.414.LS antibodies detected
Time frame: Week 48
Proportion of infants with anti-VRC07-523LS antibodies detected
Time frame: Week 48
Proportion of infants with confirmed HIV infection following receipt of study product
Time frame: Day 0 through Week 96
Frequency of study product injection site local reactions for one and two SC doses of PGT121.414.LS alone or in combination with VRC07-523LS
Time frame: Day 0 through Week 13
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network. For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network. By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https:// www.impaactnetwork.org/ resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
Data sharing details ↗ · www.impaactnetwork.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: VRC07-523LS
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