drugset / Trial / NCT01605786
Trial for Malaria Vaccine Candidate, PfPEBS (P. Falciparum Pre-Erythrocytic and Blood Stage)
Phase 1/2
Unknown
36 enrolled
Vac4All
Centre Hospitalier Universitaire Vaudois · collabEuropean Commission · collabRadboud University Medical Center · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study intends to test the hypothesis that the malaria antigen PfPEBS, manufactured as a synthetic protein and adjuvanted with aluminium hydroxide will be well-tolerated and immunogenic (Phase 1), functionally active against the erythrocytic stages (Phase 1) and efficacious (Phase 2) against the pre-erythrocytic stages in protecting against an artificial malaria challenge using Pf sporozoites in a healthy adult population.
Timeline
- Start
- 2012-05
- Primary completion
- 2013-05
- Completion
- 2013-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PfPEBS | Vaccine | 5 ug | — |
| Subject | PfPEBS | Vaccine | 30 ug | — |
| Subject | Rehydragel™ HPA | Unknown | 0.5 ml | — |