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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety and Tolerability: frequency of local and systemic reactogenicity events
Timeframe: 7 days post-vaccination
Safety and Tolerability: frequency of unsolicited adverse events
Timeframe: 28 days post-vaccination
Safety and Tolerability: frequency of vaccine-related Serious Adverse Events
Timeframe: 23 months
Safety and Tolerability: frequency of clinical safety laboratory adverse events
Timeframe: 7 days post-vaccination
Safety and Tolerability: frequency of new-onset chronic medical conditions
Timeframe: 23 months
Efficacy: proportion of subjects with detectable S. mansoni eggs
Timeframe: 12 and 23 months
Efficacy: mean S. mansoni eggs per gram of feces
Timeframe: 12 and 23 months
Efficacy: Proportion of subjects with a positive CAA test
Timeframe: 12 and 23 months