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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

October 13, 2025

Primary Completion Date

June 3, 2027

Study Completion Date

June 3, 2027

Conditions
HIV Infections
Interventions
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.

Trial Locations (1)

1862

Soweto HVTN CRS, Soweto

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Fred Hutchinson Cancer Center

OTHER

collaborator

Access to Advanced Health Institute

UNKNOWN

lead

HIV Vaccine Trials Network

NETWORK