Sporozoite Challenge of Polyprotein Vaccinees

Malaria Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

• NCT number: NCT00375128
• Study type: Interventional
• Source: European Malaria Vaccine Initiative
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2006
• Completion date: April 2007