drugset / Trial / NCT05658614
Anti-Schistosomiasis Sm14-vaccine in Senegal
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rSm14 | Protein / enzyme biologic | 50 ug | Intramuscular |
| Background | GLA-SE | Other / unclassified | 2.5 ug | Intramuscular |