Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2)

NCT07655141 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 101190620_2
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS and VRC07-523-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in Mozambique and Cameroon. The study will also learn how the body processes ePGT121v1-LS and VRC07-523-LS and whether caregivers and health workers find this treatment approach acceptable. The main questions it aims to answer are:

• Are ePGT121v1-LS and and VRC07-523-LS safe and well tolerated in infants living with HIV?
• Does adding ePGT121v1-LS and VRC07-523-LS to standard ART increase the number of infants who achieve HIV viral suppression by week 48?
• How long does it take participants receiving ePGT121v1-LS and VRC07-523-LS to achieve viral suppression compared with standard treatment alone?
• How does ePGT121v1-LS and VRC07-523-LS behave in the body after repeated subcutaneous injections? Researchers will compare infants receiving ePGT121v1-LS and VRC07-523-LS plus ART to infants receiving standard ART plus placebo (saline) to see if ePGT121v1-LS improves HIV viral suppression. Participants will:
• Continue taking standard oral ART.
• Receive 4 subcutaneous injections of ePGT121v1-LS and VRC07-523-LS or placebo every 12 weeks.
• Attend regular clinic visits for safety checks, blood tests, and HIV viral load monitoring.
• Have follow-up visits for 48 weeks.
• Participate in evaluations of treatment adherence and acceptability from the perspective of caregivers and health workers.

Conditions

HIV -1 Infection

Keywords

HIV; broadly neutralizing antibody; ePGT121v1-LS; viral load; safety; infant; children; VRC07-523-LS

Outcome Measures

Primary Outcomes (5)

• Safety (Serious adverse events)

  Proportion of participants experiencing SAEs throughout the whole trial.

  48 weeks

• Virological suppression

  * Proportion of infants achieving virological suppression (plasma HIV-1 RNA \< 40 copies/mL) at week 48, as well as over the 48 week follow-up period. * Time to first virological suppression, defined as the time from randomization to the first post-baseline measurement of plasma HIV-1 RNA \< 40 copies/mL.

  48 weeks

• Time to virological suppression

  • Time to first virological suppression, defined as the time from randomization to the first post-baseline measurement of plasma HIV-1 RNA \< 40 copies/mL.

  48 weeks

• Tolerability of the treatment (participants who discontinue)

  • Proportion of participants who discontinue due to toxicity or tolerability issues.

  48 weeks

• Tolerability of the injection

  • Median score of pain assessment scale after administration of bNAb (FLACC scale).

  1 hour

Secondary Outcomes (5)

• PK profile of ePGT121v1-LS and of VRC07-523-LS

  12 weeks

• Time to sustained virological suppression

  48 weeks

• Longitudinal virological response

  48 weeks

• Acceptability

  48 weeks

• Adverse events

  48 weeks

Other Outcomes (8)

• All-cause mortality and number of hospitalizations.

  48 weeks

• Clinical features at baseline and during follow-up

  48 weeks

• HIV-1 DNA

  48 weeks

Study Arms (2)

ePGT121v1-LS and VRC07-523-LS

ACTIVE COMPARATOR

4 injections of the bNAb ePGT121v1-LS and 4 injections of and VRC07-523-LS, separated 12 weeks, plus antiretroviral treatment.

Drug: Broadly neutralizing antibody (bNAb) ePGT121v1-LS; Drug: Broadly neutralizing antibody (bNAb) VRC07-523-LS

Placebo (saline)

PLACEBO COMPARATOR

4 injections of saline, separated 12 weeks, plus antiretroviral treatment.

Drug: Saline (0.9% NaCl)

Interventions

Broadly neutralizing antibody (bNAb) ePGT121v1-LS DRUG

Administration of subcutaneous ePGT121v1LS, 4 doses, separate 12 weeks away.

ePGT121v1-LS and VRC07-523-LS

Saline (0.9% NaCl) DRUG

Administration of subcutaneous saline, 4 doses, separate 12 weeks away.

Placebo (saline)

Broadly neutralizing antibody (bNAb) VRC07-523-LS DRUG

Administration of subcutaneous ePGT121v1LS, 4 doses, separate 12 weeks away.

ePGT121v1-LS and VRC07-523-LS

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants from 1 to 365 days old at the time of enrolment.
• Living with HIV-1, diagnosed with an approved assay detecting HIV nucleic acids in blood.
• Weight \> 2.5 kg at enrolment.
• ART-naïve or ≤ 30 days of triple ART at screening (not including prophylaxis in HIV-exposed).
• Clinically stable and can be managed as outpatient (participants identified in-hospital can start the trial at their first routine visit).
• Parent or legal guardian able to provide Informed consent (IC).

You may not qualify if:

• Participation in other concurrent research studies that, in the opinion of the principal investigator and central team, would interfere with the objectives of this study.
• Previous receipt of bNAbs against HIV.
• Serious Adverse Reactions (SARs) to the investigational medicinal product (IMP) or its components.
• Intravenous (IV) immunoglobulins received within 90 days before IMP administration.
• Any clinically significant acute or chronic illness or condition at screening that, in the opinion of the principal investigator/designee, renders the participant unfit to participate in the study or jeopardizes the safety or rights of the participant. Including, but not restricted to:
• Evidence of active tuberculosis (TB) disease at the time of enrolment.
• Life-threatening condition associated with a high risk of death within 30 days of enrolment, as determined by the study clinician.
• Severe acute malnutrition with complications.
• Severe neurological illness.
• Hemodynamically significant severe congenital heart disease.
• Active malignancies.
• Life-threatening bleeding disorder.
• Unwillingness to have blood drawn
• Unable to receive SC medications.
• Chronic or recurrent urticaria or any other chronic dermatological condition that may be confused with local Adverse Reactions (ARs).

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• Africa Health Research Institute: collaborator
• PENTA Foundation: collaborator
• International AIDS Vaccine Initiative: collaborator
• University of Witwatersrand, South Africa: collaborator
• Faculty of Medical Sciences, Radboud University of Medical Center: collaborator
• Servicio Madrileño de Salud (SERMAS): collaborator
• Eduardo Mondlane University: collaborator
• Fundaçao Ariel Glaser contra o SIDA Pediatrico: collaborator
• Centro de Investigação em Saúde de Manhiça: collaborator
• University of Rome Tor Vergata: collaborator
• Centre Pasteur du Cameroun: collaborator
• Barcelona Institute for Global Health: collaborator

MeSH Terms

Interventions

Broadly Neutralizing Antibodies; Sodium Chloride

Intervention Hierarchy (Ancestors)

Antibodies, Neutralizing; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Alfredo Tagarro, PhD

CONTACT

+34606194888; alfredo.tagarro@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step 1 (safety lead-in): Non-randomized single arm with ePGT121v1-LS and VRC07-523-LS on top of antiretroviral therapy (ART). Step 2 (safety and efficacy): Single blind, randomized, parallel group with ePGT121v1-LS and VRC07-523-LS on top of ART compared to oral ART and placebo (saline).

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The individual de-identified participant data (including data dictionary), statistical code, and any other materials will be accessible after the end of the project in an open repository upon request.
• Access Criteria: Upon reasonable request.