drugset / Trial / NCT02071758
Phase 1 LEISH-F3 + SLA-SE Vaccine Trial in Healthy Adult Volunteers
Phase 1
Completed
39 enrolled
Access to Advanced Health Institute (AAHI)
Bill and Melinda Gates Foundation · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of visceral leishmaniasis.
Timeline
- Start
- 2014-04
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLA-SE | Other / unclassified | 10 ug | Intramuscular |
| Subject | LEISH-F3 | Protein / enzyme biologic | 5 ug | Intramuscular |
| Subject | LEISH-F3 | Protein / enzyme biologic | 20 ug | Intramuscular |
| Subject | SLA-SE | Unknown | 5 ug | Intramuscular |
| Subject | SLA-SE | Unknown | 10 ug | Intramuscular |