This is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study will recruit 72 healthy adult males and non-pregnant females from a single clinical center to test two formulations of Sm-TSP-2 vaccine (using the Alhydrogel® only, and using Alhydrogel® plus GLA-AF), each at 3 different doses: 10ug, 30ug, and 100ug. The primary objective is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10ug, 30ug, or 100ug) with or without GLA-AF vaccine given as three doses administered on Days 1, 57, and 113.
Age range
18 Years – 50 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
The occurrence of new-onset chronic medical conditions (including AESI) through 12 months after the third study vaccination.
Timeframe: Through 12 months after the third study vaccination ( Day 478)
The occurrence of solicited injection site reactogenicity on the day of each study vaccination through 7 days after each study vaccination
Timeframe: Day 113-120
The occurrence of solicited injection site reactogenicity on the day of each study vaccination through 7 days after each study vaccination
Timeframe: Day 57-64
The occurrence of solicited injection site reactogenicity on the day of each study vaccination through 7 days after each study vaccination.
Timeframe: Day 1-8
The occurrence of solicited systemic reactogenicity on the day of each study vaccination through 7 days after each study vaccination.
Timeframe: Day 113-120
The occurrence of solicited systemic reactogenicity on the day of each study vaccination through 7 days after each study vaccination
Timeframe: Day 1-8
The occurrence of solicited systemic reactogenicity on the day of each study vaccination through 7 days after each study vaccination.
Timeframe: Day 57-64
The occurrence of study vaccine-related SAEs from the time of the first study vaccination through approximately 12 months after the last study vaccination
Timeframe: Day 1-12 months after the last study vaccination
The occurrence of vaccine-related clinical safety laboratory adverse events
Timeframe: Day 1-478