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

• Status: Completed
• Trial end date: 2019-08-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oswaldo Cruz Foundation
• Collaborators: Biomedical Research Center EPLS; IDRI; Orygen Biotecnologia SA
• Treatments: Pharmaceutical Solutions; Vaccines

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.