NCT06796686View on ClinicalTrials.gov

Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health

PHASE1RecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

March 17, 2025

Primary Completion Date

January 15, 2027

Study Completion Date

January 15, 2027

Conditions
HIV
Interventions
BIOLOGICAL

426c.Mod.Core-C4b

426c.Mod.Core-C4b is supplied at a concentration of 2 mg/mL, 0.55 mL per vial.

BIOLOGICAL

HxB2.WT.Core-C4b

HxB2.WT.Core-C4b is supplied at a concentration of 1 mg/mL, 0.5 mL per vial

BIOLOGICAL

3M-052-AF adjuvant

immune response modifier (IRM)

OTHER

Aluminum hydroxide suspension (Alum) adjuvant

Alhydrogel.

OTHER

Diluent

Tris-NaCl buffer

Trial Locations (6)

10032

NOT_YET_RECRUITING

Columbia Physicians & Surgeons, New York

10065

WITHDRAWN

NY Blood Center CRS, New York

30030

RECRUITING

The Hope Clinic of the Emory Vaccine Research Center; Emory University, Decatur

30308

NOT_YET_RECRUITING

Ponce de Leon Center CRS, Atlanta

94102

NOT_YET_RECRUITING

Bridge HIV, San Francisco Department of Public Health, San Francisco

02115

RECRUITING

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

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH