A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

August 15, 2022

Primary Completion Date

January 24, 2024

Study Completion Date

January 24, 2024

Conditions
HIV
Interventions
BIOLOGICAL

FP conjugate vaccine (25 mcg)

"FP8v1-rTTHC (FP conjugate vaccine) is an HIV-1 fusion peptide conjugated to recombinant tetanus toxoid heavy chain fragment C (rTTHC) via sulfo-SIAB chemical linker.~Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites."

BIOLOGICAL

FP conjugate vaccine (200 mcg)

"FP8v1-rTTHC (FP conjugate vaccine) is an HIV-1 fusion peptide conjugated to recombinant tetanus toxoid heavy chain fragment C (rTTHC) via sulfo-SIAB chemical linker.~Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites."

BIOLOGICAL

Trimer 6931 (100 mcg)

"HIV-1 Trimer 6931 (Trimer 6931) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from consensus clade C sequence (ConC).~Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites."

BIOLOGICAL

Trimer 6931 (200 mcg)

"HIV-1 Trimer 6931 (Trimer 6931) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from consensus clade C sequence (ConC).~Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites."

BIOLOGICAL

Trimer 4571 (200 mcg)

"HIV-1 Trimer 4571 (Trimer 4571) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505.~Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites."

BIOLOGICAL

Trimer 4571 (100 mcg)

"HIV-1 Trimer 4571 (Trimer 4571) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505.~Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites."

Trial Locations (6)

10065

New York Blood Center CRS [31801], New York

14642

University of Rochester Vaccines to Prevent HIV Infection CRS [31467], Rochester

15213

University of Pittsburgh CRS [1001], Pittsburgh

30308

Atlanta - Hope Clinic, Atlanta

30329

Columbia P&S CRS [30329], New York

02115

BIDMC Vcrs [32077], 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