drugset / Trial / NCT03503058
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
Phase 2
Completed
345 enrolled
Sanaria Inc.
Congressionally Directed Medical Research Programs · collabIndonesia University · collabOxford University Clinical Research Unit Indonesia · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring malaria in healthy Indonesian soldiers deployed to eastern Indonesia.
Timeline
- Start
- 2022-05-07
- Primary completion
- 2024-02-27
- Completion
- 2024-02-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Chloroquine | Small molecule | 5 mg/kg | Oral |
| Subject | PfSPZ Challenge | Vaccine | 200000 unknown | Other |
| Subject | PfSPZ Vaccine | Vaccine | 900000 unknown | Other |