Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults

Summary

The study will recruit up to 290 healthy adult males and non-pregnant females into a two-part clinical trial of a vaccine to protect against schistosomiasis caused by infection with S. mansoni. Two formulations of the Sm-TSP-2 vaccine will be tested: one using Alhydrogel® only, and one using Alhydrogel® plus AP 10-701, each at 3 different doses of antigen: 10mcg, 30mcg, and 100mcg.

The first part of the study will be a Phase I dose-escalation safety and immunogenicity study followed by a Phase IIb trial in which a larger number of adults will be enrolled to assess the impact of the vaccine on infection with S. mansoni. The impact of the vaccine on infection with S. haematobium will also be assessed although this will be exploratory given that potential cross-protection against this species is only hypothetical at this point.

Conditions

• Schistosomiasis
• Schistosoma 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

Sponsors & Collaborators

• George Washington University

  collaborator OTHER

• Makerere University Walter Reed Project

  collaborator UNKNOWN

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Hannah Kibuuka, MD · Makerere University Walter Reed Project

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-07

Primary Completion

2024-11-13

Completion

2024-11-13

FDA Drug

Yes

Countries

• Uganda

Study Locations