NCT06613789

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

A Partially Randomized Phase 1 Clinical Trial 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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: HIV Vaccine Trials Network · Network
• Sex: All
• Age: 7 Days
• Healthy volunteers: Accepted

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

Detailed description

This study will compare the safety and immunogenicity of an experimental HIV vaccine in infants with perinatal HIV exposure who are without HIV at birth. The study vaccine is called 426c.Mod.Core-C4b. The vaccine is mixed with an adjuvant called 3M-052-AF + Alum. This study is divided into 2 parts: Part A and B. Part A has 4 groups, while Part B has 2 groups. Part A of the study is testing the vaccine alone or in combination with different doses of adjuvant. Part B is testing study vaccine and the safest dose of adjuvants from Part A versus placebo. Depending on their group, participants will receive 426c.Mod.Core-C4b, 426c.Mod.Core-C4b vaccine adjuvanted with 3M-052-AF + Alum, or a placebo by injection at Months 0, 3, and 7. Additional study visits will occur at Day 1, Week 2, Month 3 1/2, Month 7 1/2, Month 10, Year 1, Year 1 1/2, and Year 1 3/4. Study visits may include physical exams, blood and saliva collection for the infants and questionnaires, counselling, blood, and optional breastmilk collection for the mothers of infants.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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.
BIOLOGICAL	Placebo and Diluent	Tris-NaCl buffer.

Timeline

• Start date: 2026-07-13
• Primary completion: 2027-06-03
• Completion: 2027-06-03
• First posted: 2024-09-26
• Last updated: 2025-12-09

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study