HIV Vaccine in HIV-uninfected Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

February 3, 2022

Primary Completion Date

July 1, 2024

Study Completion Date

July 1, 2024

Conditions
HIV
Interventions
BIOLOGICAL

IHV01

IHV01 consists of the Full-Length Single Chain (FLSC) gp120-CD4 chimera subunit HIV-1 vaccine formulated in aluminum phosphate adjuvant. It is encoded by a synthetic gene, which contains a human codon-optimized HIV (BaL) gp120 sequence followed by human CD4D1D2, with a flexible 20-amino acid linker.

BIOLOGICAL

A244

A244 consists of the gp120 envelope glycoprotein HIV-1 subtype CRF\_01AE A244 derived from the CM244 CRF\_01AE. The A244 gp120 envelope has an 11 amino N-terminal deletion, similar to the A244 protein used in AIDSVAX B/E. The aluminum hydroxide fluid gel (AHFG) adjuvant that is mixed with A244 consists of Rehydragel HPA that is diluted with sterile water for injection to a concentration of 5 + /- 1mg/mL.

BIOLOGICAL

ALFQ

ALFQ (Army Liposomal Formulation) is a liposomal adjuvant containing a synthetic monophosphoryl lipid A (MPLA) with the addition of QS-21.

OTHER

Placebo

Normal saline (Sodium Chloride for injection USP, 0.9%) will be used as placebo.

Trial Locations (2)

10400

Armed Forces Research Institute of Medical Sciences, Bangkok

Mahidol University, Bangkok

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Duke University

OTHER

collaborator

University of Maryland, Baltimore

OTHER

collaborator

Case Western Reserve University

OTHER

lead

U.S. Army Medical Research and Development Command

FED

NCT04658667 - HIV Vaccine in HIV-uninfected Adults | Biotech Hunter | Biotech Hunter