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:
Participant gender:
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
Details
Lead Sponsor:
Oswaldo Cruz Foundation
Collaborators:
Biomedical Research Center EPLS IDRI Orygen Biotecnologia SA