NCT00375128

Sporozoite Challenge of Polyprotein Vaccinees

Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With the Polyprotein Malaria Vaccines 'FP9-PP, MVA-PP' and Control Non-Vaccinated Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (planned)
• Sponsor: European Vaccine Initiative · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study examines the ability of two new malaria vaccines (FP9-PP and MVA-PP) to prevent the development of malaria infection after controlled exposure to the parasite. Volunteers for this trial will have received these vaccines in the preceding trial VAC027.1.

Detailed description

Malaria infection kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is clearly a great need for a safe effective malaria vaccine. The purpose of this study is to test the clinical efficacy of two candidate malaria vaccines (FP9-PP and MVA-PP). These live viral vector vaccines were administered in a 'prime boost' regime in the preceding trial VAC027.1. Volunteers will now be exposed to 5 infective bites from mosquitoes carrying P. falciparum malaria. This trial will: 1. Measure efficacy as the time in hours from malaria exposure to blood film positive for malaria parasites 2. Examine immunogenicity before and after malaria infection 3. Measure longer term vaccine efficacy by re-challenging any protected volunteers 6 - 12 months later

Conditions

• Malaria, Falciparum
• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	FP9-PP (FP9 polyprotein)
BIOLOGICAL	MVA-PP (Modified Virus Ankara polyprotein)

Timeline

• Start date: 2006-09-01
• Completion: 2007-04-01
• First posted: 2006-09-12
• Last updated: 2007-10-19

Locations

2 sites across 1 country: United Kingdom