Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

October 7, 2019

Primary Completion Date

November 13, 2024

Study Completion Date

September 30, 2025

Conditions
SchistosomiasisSchistosoma Mansoni
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

ENGERIX-B Hepatitis B Vaccine

Recombinant hepatitis B vaccine containing 10 mcg recombinant hepatitis B surface antigen per dose

Trial Locations (1)

Unknown

Makerere University Walter Reed Project, Kampala

All Listed Sponsors
collaborator

George Washington University

OTHER

collaborator

Makerere University Walter Reed Project

UNKNOWN

lead

Baylor College of Medicine

OTHER