A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 7, 2024

Primary Completion Date

December 30, 2025

Study Completion Date

September 12, 2026

Conditions
HIV
Interventions
BIOLOGICAL

CD4BS CH505M5 Pr-NP1

A ferritin NP expressing 8 copies of an HIV-1 Env protein trimer. To be administered intramuscularly (IM).

BIOLOGICAL

CH505TF chTrimer

A stabilized chimeric SOSIP Env trimer protein with the N-terminal sequence of CH505 TF gp120 Env transplanted into the BG505 SOSIP sequence. To be administered IM.

BIOLOGICAL

3M-052-AF (labeled as AP 60-702)

An aqueous formulation (AF) of the small molecule imidazoquinoline immune response modifier (IRM) 3M-052; toll-like receptor (TLR)7/8 agonist.

BIOLOGICAL

Aluminum Hydroxide Suspension (Alum)

Alum to be administered IM as 500 mcg (aluminum content) admixed with 3M-052-AF (5 mcg) along with CD4BS CH505M5 Pr-NP1 and CH505 TF chTrimer.

BIOLOGICAL

ACU-026-001-1 (labeled as empty LNP)

An AF consisting of 4 lipid components.

Trial Locations (6)

2571

Klerksdorp CRS (Site ID: 30325), Klerksdorp

4110

Isipingo CRS (Site ID: 31635), Isipingo

30308

The Ponce de Leon Center CRS (Site ID: 5802), Atlanta

35222

Alabama CRS (Site ID: 31788), Birmingham

37232

Vanderbilt Vaccine (VV) CRS (Site ID: 30352), Nashville

0152

Setshaba Research Centre CRS (Site ID: 31829), Soshanguve

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Department of Health and Human Services

FED

collaborator

Duke University

OTHER

collaborator

Access to Advanced Health Institute (AAHI)

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT06267872 - A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum | Biotech Hunter | Biotech Hunter