143
Participants
Start Date
March 15, 2021
Primary Completion Date
February 13, 2024
Study Completion Date
February 13, 2024
Env-C Plasmid DNA
2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein
100 µg per dose. Administered by intramuscular injection.
Rehydragel®
Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43
Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
dmLT
Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
Placebo (IM)
0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
Placebo (TCl)
Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
Kenya Medical Research Institute/Walter Reed Project, Clinical Research Centre, Off Hospital Road, Kericho
Walter Reed Army Institute of Research (WRAIR)
FED
US Military HIV Research Program
NETWORK
The Emmes Company, LLC
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH