drugset / Trial / NCT01031524
Trial to Assess the Efficacy of Malaria Vaccine PfCS 102
Phase 1/2
Completed
16 enrolled
Swiss Tropical & Public Health Institute
Centre Hospitalier Universitaire Vaudois · collabRadboud University Medical Center · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.
Timeline
- Start
- 2004-03
- Primary completion
- 2004-07
- Completion
- 2004-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PfCS102 | Vaccine | 30 ug | — |
| Comparator | Montanide ISA 720 | Unknown | — | — |