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

Malaria Clinical Trial

Official title: 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

Clinical Trial 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.

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 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) ;

Study Design

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

• NCT number: NCT00374998
• Study type: Interventional
• Source: European Malaria Vaccine Initiative
• Status: Completed
• Phase: Phase 1
• Start date: April 2006
• Completion date: January 2007