Status:
COMPLETED
Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children
Lead Sponsor:
Oswaldo Cruz Foundation
Collaborating Sponsors:
Orygen Biotecnologia SA
Biomedical Research Center EPLS
Conditions:
Schistosomiasis
Eligibility:
All Genders
8-11 years
Phase:
PHASE2
Brief 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...
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) injecti...
Eligibility Criteria
Inclusion
- School children, of public schools in villages of Saint Louis region (Senegal), female or male, 8 to 11 years old (inclusive) at the time of inclusion.
- Residence in the area during the period of the study.
- Free of obvious/severe health problems except schistosomiasis, as established by clinical examination.
- Written informed consent to participate obtained from subject's parents or legal guardian.
- Free of obvious/severe health problems except schistosomiasis, established by blood analysis, i.e. hematological exams, liver and renal function tests.
- Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-2 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium
- Children of Group 1: not infected, no schistosomiasis history and living in area/village free of Sm and Sh transmission.
- Children Groups 2 \& 3: infected with mansoni or/and haematobium schistosomiasis.
Exclusion
- School child who does not respond to one of the inclusion criteria
- Child under 20kg of body weight
- Vaccination within 90 days preceding the first dose of Sm14 vaccine candidate, or planned use during the study period.
- Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs.
- Known hypersensitivity to any component in the Sm14 vaccine or history of allergic disease.
- Knowledge of non-infectious chronic disease
- Known acute disease.
- Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled.
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2019
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03799510
Start Date
December 13 2018
End Date
August 7 2019
Last Update
December 9 2019
Active Locations (1)
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1
Biomedical Research Center EPLS
Saint-Louis, Senegal, BP226