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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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