drugset / Trial / NCT05999825
Sm-p80 Schistosomiasis Challenge Study
Phase 2
Unknown
48 enrolled
Leiden University Medical Center
MRC/UVRI and LSHTM Uganda Research Unit · collabTexas Tech University Health Sciences Center · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
The goal of this clinical trial is to learn about the Sm-p80 + GLA-SE (Schistoshield®) vaccine in healthy participants who have not had schistosomiasis before. The main questions it aims to answer are: * if the vaccine is safe * if after vaccinated people start producing antibodies * if the vaccine works against schistosomiasis. Participants will receive three vaccines (or placebo) and are then exposed to 20 male Schistosoma cercariae. Afterwards they are treated with praziquantel to cure the infection. Researchers will compare the group vaccinated with Schistoshield® and placebo (fake vaccination) to see if the vaccine has worked.
Timeline
- Start
- 2024-09
- Primary completion
- 2025-04
- Completion
- 2025-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLA-SE | Other / unclassified | 5 ug | Intramuscular |
| Subject | Sm-p80 | Protein / enzyme biologic | 30 ug | Intramuscular |