Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIV

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

August 22, 2022

Primary Completion Date

February 14, 2026

Study Completion Date

May 21, 2026

Conditions
HIV-1-infection
Interventions
BIOLOGICAL

426c.Mod.Core-C4b 30 mcg

Administered via injection as a split dose into the deltoid muscle (both left and right).

BIOLOGICAL

426c.Mod.Core-C4b 100 mcg

Administered via injection as a split dose into the deltoid muscle (both left and right).

BIOLOGICAL

426c.Mod.Core-C4b 300 mcg

Administered via injection as a split dose into the deltoid muscle (both left and right).

OTHER

Placebo

Administered via injection as a split dose into the deltoid muscle (both left and right).

BIOLOGICAL

BG505

A soluble, cleavage-competent, trimeric HIV-1 envelope glycoprotein gp140 formulated at 2 mg/mL, 0.55 mL per vial, in 20 mM Tris, 100 mM NaCl, pH 7.5 will be admixed with 3M-052-AF (5 mcg) + Alum (500 mcg

Trial Locations (6)

10032

Columbia P&S CRS, New York

35222

Alabama CRS, Birmingham

94102

Bridge HIV CRS, San Francisco

98104

Seattle Vaccine and Prevention CRS, Seattle

30308-2012

The Ponce de Leon Center CRS, Atlanta

02115-6110

Brigham and Women's Hospital Vaccine CRS (BWH VCRS), Boston

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Department of Health and Human Services

FED

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH