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Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With 3M-052-AF+Alum in Infants Perinatally Exposed to HIV But Uninfected

NCT06613789 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-12-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of 426c.Mod.Core-C4b vaccine adjuvanted with 3M-052-AF + Alum in infants with perinatal HIV exposure who are without HIV at birth

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Placebo and Diluent

Tris-NaCl buffer.

BIOLOGICAL

426c.Mod.Core-C4b

self-assembling nanoparticle expressing up to 7 molecules of the 426c.Mod.Core envelope immunogen.

BIOLOGICAL

3M-052-AF

3M-052-AF is an aqueous formulation (AF) of a lipidated small molecule imidazoquinoline that is a Toll-like receptor (TLR)7/8 and inflammasome agonist. To be administered as 0.3 mcg, 0.75 mcg, or 1.5 mcg admixed with 426c.Mod.Core-C4b, with Alum

BIOLOGICAL

Aluminum hydroxide suspension (Alum)

Aluminum hydroxide suspension (Alum) to be administered as 250 mcg (aluminum content) admixed with 426c.Mod.Core-C4b with 3M-052-AF.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • Access to Advanced Health Institute

    collaborator UNKNOWN

  • HIV Vaccine Trials Network

    lead NETWORK

Principal Investigators

  • Amy Violari · Perinatal HIV Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2027-06-03
Completion
2027-06-03
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06613789 on ClinicalTrials.gov