290
Participants
Start Date
October 7, 2019
Primary Completion Date
November 13, 2024
Study Completion Date
September 30, 2025
Sm-TSP-2/Alhydrogel® vaccine
The Sm-TSP-2/Alhydrogel® candidate vaccine contains recombinant Sm-TSP-2 adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10mM imidazole buffer containing 2mM phosphate and 15% sucrose, with pH 7.4 ± 0.1. The final concentrations of Sm-TSP-2 and Alhydrogel® in the drug product are 0.1mg/ml and 0.8mg/ml respectively.
Sm-TSP-2/Alhydrogel® vaccine plus AP 10-701
The Sm-TSP-2/Alhydrogel® candidate vaccine co-administered with the immunostimulant, AP 10-701. b) AP 10-701, also known as Gluco-Pyranosylphospho-Lipid A Aqueous Formulation (GLA-AF), is a Toll-like Receptor-4 agonist. Point-of-injection formulations with this immunostimulant will be prepared immediately prior to vaccination by adding an appropriate volume of AP 10-701 to Sm-TSP-2/Alhydrogel® and withdrawing an appropriate volume to administer the desired amount of Sm-TSP-2 plus 5µg GLA-AF.
ENGERIX-B Hepatitis B Vaccine
Recombinant hepatitis B vaccine containing 10 mcg recombinant hepatitis B surface antigen per dose
Makerere University Walter Reed Project, Kampala
George Washington University
OTHER
Makerere University Walter Reed Project
UNKNOWN
Baylor College of Medicine
OTHER