NCT01031524

Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

Randomized Double-blind Controlled Phase I/IIa Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (282-383) to Protect Against Artificial Challenge With P. Falciparum

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Swiss Tropical & Public Health Institute · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
BIOLOGICAL	PfCS102	Antigen of the sporozoite protein
BIOLOGICAL	Montanide ISA 720	adjuvant alone

Timeline

• Start date: 2004-03-01
• Primary completion: 2004-07-01
• Completion: 2004-11-01
• First posted: 2009-12-14
• Last updated: 2009-12-14

Locations

1 site across 1 country: Switzerland