Study: NCT03910972

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel® vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel® vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel® vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel® vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel® vaccine plus AP 10-701
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel® vaccine plus AP 10-701
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel® vaccine plus AP 10-701
Description: 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.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: ENGERIX-B Hepatitis B Vaccine
Description: Recombinant hepatitis B vaccine containing 10 mcg recombinant hepatitis B surface antigen per dose

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: ENGERIX-B Hepatitis B Vaccine
Description: Recombinant hepatitis B vaccine containing 10 mcg recombinant hepatitis B surface antigen per dose