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The clinical trial phase 2b is designed to assess the safety, the specific immune response and the anti-parasite effect of the active ingredient (protein + adjuvant) in healthy and then in infected school children from 8 to 11 years of age with intestinal and urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis.
A phase 2b trial, self-contained, open-label, randomized, dose-escalation study in three parallel arms, two of them formed by groups of healthy or infected school children, both receiving three (3) injections at D0, D28, D56; both groups receiving 50 μg Sm14 vaccine candidate solution, combined with 2.5μg GLA-SE. The third group is composed by non-vaccinated infected school children.
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 at W13 and W21 during the follow-up.
Blood samples for immune response analysis at W12 and W20.
Sm14, GLA-SE solution
Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS)
Active, not recruiting
Oswaldo Cruz Foundation
Published on BioPortfolio: 2019-01-16T12:32:17-0500
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Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).
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The pressure required to prevent the passage of solvent through a semipermeable membrane that separates a pure solvent from a solution of the solvent and solute or that separates different concentrations of a solution. It is proportional to the osmolality of the solution.
Solution that is usually 10 percent glucose but may be higher. An isotonic solution of glucose is 5 percent.
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