Schistosomiasis Clinical Trial
Official title:
Safety and Immunogenicity Evaluation of the Vaccine Candidate Sm14 in Combination With the Adjuvant Glucopyranosyl Lipid A (GLA-SE) in Adults Living in Endemic Regions for S. Mansoni and S. Haematobium in Senegal. A Comparative, Randomized, Open-label Trial
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.
A phase 2a trial, self-contained, open-label, randomized, dose-escalation study in two
parallel arms receiving three (3) injections at D0, D28, D56; both groups receiving 50 μg
Sm14 vaccine candidate solution, either combined with 2.5µg GLA-SE for the first group and
5µg for the second one in adults living in a S. mansoni and S. haematobium endemic area.
Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP)
conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted
with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration.
Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a
safety evaluation at 24 hrs and 48 hrs, after each injection.
Blood analysis: Liver function tests - renal function tests - blood counts, at W-1 before
inclusion, and then 7 days after each injections and at W13 and W21 during the follow-up.
Blood samples for immune response analysis at time of each injection, and then W12 and W20.
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