Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions

• Status: Completed
• Trial end date: 2017-06-02
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

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

Criteria

Inclusion Criteria:

• Adults, male, 18 to 49 years old (inclusive) at the time of inclusion.

• Living in one of selected villages in Saint-Louis Region (Senegal).

• Free of obvious/severe health problems except schistosomiasis, as established by clinical examination and blood analysis, i.e. hematological exams, liver and renal function tests.

• Written informed consent to participate obtained

• Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-5 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium

• Residence in the area during the period of the study.

Exclusion Criteria:

• Adult who does not respond to one of the inclusion criteria

• 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

• Acute disease at time of enrollment.

• Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled.

• Non residence in the study area or intent to move during the study period