NCT03799510

Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children

Safety and Immunogenicity Evaluation of the Vaccine Candidate Sm14 Against Schistosomiasis in Senegalese School Children Healthy or Infected With S. Mansoni and/or S. Haematobium. A Comparative, Randomized, Controlled, Open-label Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Oswaldo Cruz Foundation · Academic / Other
• Sex: All
• Age: 8 Years – 11 Years
• Healthy volunteers: Accepted

Summary

The clinical trial phase 2b is designed to assess the safety and the specific immune response of the active ingredient (protein + adjuvant) in healthy and then in infected school children from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis.

Detailed description

A phase 2b trial, self-contained, open-label, controlled, randomized study in three parallel arms, two of them formed by groups of healthy or infected school children, both receiving three (3) injections at D0, W4 (Week 4), W8; 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 W9 and W21 during the follow-up. Blood samples for immune response analysis at D0, W12 and W21.

Conditions

• Schistosomiasis

Interventions

Type	Name	Description
BIOLOGICAL	Sm14	Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week).
DRUG	GLA-SE solution	The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection.

Timeline

• Start date: 2018-12-13
• Primary completion: 2019-07-01
• Completion: 2019-08-07
• First posted: 2019-01-10
• Last updated: 2019-12-09

Locations

1 site across 1 country: Senegal