The clinical trial phase 2a is designed to assess the safety of the active ingredient (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49 years of age with a history of infection with intestinal and urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in adults is considered to be a preliminary step in safety before starting trials in children in endemic areas to S. mansoni or S. haematobium, target population of the vaccine.
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Timeframe: within 7 days of the administration of the first dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: D30-D37: within 7 days of the administration of the second dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: D60-67 : within 7 days of the administration of the third dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: D90 : three months after the first injection
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: D120 : four months after the first injection