NCT00374998

Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP

A Phase I Study to Assess the Safety and Immunogenicity of the Polyprotein Malaria Vaccine Candidates FP9 PP and MVA PP in Healthy Adults Using a Prime-Boost Delivery Schedule

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (planned)
• Sponsor: European Vaccine Initiative · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers to determine their safety and ability to induce a measurable immune response against malaria.

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 two candidate malaria vaccines (FP9-PP and MVA-PP) in different concentrations and combinations. These live viral vectors encode a 'polyprotein' of six fused malaria antigens expressed at liver and blood stages of the malaria parasite lifecycle. MVA-PP uses the Modified Virus Ankara vector, a weakened form of the smallpox vaccine, vaccinia. FP9-PP uses a highly attenuated avian pox virus (FP9) as the vector instead. The two vaccines will be used in combination in a 'prime boost' strategy to enhance the response of the cellular immune system. This study will: 1. Examine safety 2. Examine immunogenicity 3. Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study (VAC027.2)

Conditions

• Malaria, Falciparum
• Malaria

Interventions

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

Timeline

• Start date: 2006-04-01
• Completion: 2007-01-01
• First posted: 2006-09-12
• Last updated: 2007-03-01

Locations

1 site across 1 country: United Kingdom