drugset / Trial / NCT05658614

Anti-Schistosomiasis Sm14-vaccine in Senegal

NCT05658614

Phase 2 Unknown 120 enrolled Oswaldo Cruz Foundation
RandomizedParallel-groupOpen-labelPrevention

Summary

Previous clinical trials have already demonstrated the safety of the candidate vaccine in adults as well as in children, in good health or infected with schistosomiasis. Regarding the induced immune response, more than 80% of vaccinated subjects were seroconverted after three vaccine injections. The induced immune response was substantial but transient. In order to obtain a more lasting immune response, the investigator will experiment with a new vaccination schedule (2 injections 1-month interval and the 3rd injection 5 months after the first dose), versus the vaccine schedule initially used (3 injections at 1-month interval). This trial will be the last phase 2 before testing the efficacy of the rSm14 vaccine candidate.

Timeline

Start
2022-07-01
Primary completion
2023-09-15
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject rSm14 Protein / enzyme biologic 50 ug Intramuscular
Background GLA-SE Other / unclassified 2.5 ug Intramuscular