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

Phase 1

Completed

• Conditions: Malaria, Falciparum; Malaria

• Registration Number: NCT00374998
• Lead Sponsor: European Vaccine Initiative

Brief 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)

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-09-10
• Study First Submitted QC: 2006-09-10
• Study First Posted: 2006-09-12
• Study Completion: 2007-01
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-28
• Last Update Posted: 2007-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Healthy adults aged 18 to 50 years
• Resident in or near Oxford, UK for the duration of the vaccination study
• Willingness to allow the investigators to access hospital and General Practitioner medical notes
• For females only, willingness to practice continuous effective contraception during the study and if participating, during the subsequent challenge study.
• Agreement to refrain from blood donation during the course of the study
• Written informed consent
• Willingness to undergo an HIV test

Exclusion Criteria

• Any deviation from the protocol-defined normal range in biochemistry or haematology blood tests or in urine analysis
• Prior receipt of an investigational malaria vaccine
• Use of any investigational or non-registered drug, vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
• Administration of chronic immunosuppressive drugs or other immune modifying drugs within six months of vaccination
• History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet within 2 weeks prior to the challenge
• Any history of malaria
• Travel to a malaria endemic country within the previous 6 months prior to the planned challenge
• Planned travel to malarious areas during the study period
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
• Evidence of cardiovascular disease
• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• History of haemoglobinopathies
• History of diabetes mellitus
• Chronic or active neurological disease
• Chronic gastrointestinal disease
• History of more than 2 hospitalisations for invasive bacterial infections
• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• Seropositive for hepatitis B surface antigen (HBsAg)
• Seropositive for hepatitis C virus (antibodies to HCV)
• Hepatomegaly, right upper quadrant abdominal pain or tenderness
• Evidence of serious psychiatric condition
• Any other on-going chronic illness requiring hospital specialist supervision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immediate reactogenicity
Adverse events occurring before the end of the trial
Biological safety (haematological and biochemical indices)

Secondary Outcome Measures

Name	Time	Method
T-cell immunogenicity (prime-boost groups)
Humoral immunogenicity (prime-boost groups)
Gene expression (prime-boost groups)

Trial Locations

Locations (1)

Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford; 🇬🇧 Oxford, United Kingdom