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

NCT ID: NCT00374998

Last Updated: 2007-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-01-31

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)

Conditions

Malaria, Falciparum; Malaria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

FP9-PP (FP9 polyprotein)

Intervention Type: BIOLOGICAL

MVA-PP (Modified Virus Ankara polyprotein)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

Wellcome Trust

OTHER

Sponsor Role: collaborator

European Vaccine Initiative

OTHER

Sponsor Role: lead

Principal Investigators

Adrian VS Hill, MA, BM BCh, DPhil, DM

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

EudraCT number: 2004-002424-17

Identifier Type: -

Identifier Source: secondary_id

EMVI trial identifier: PP_1_04

Identifier Type: -

Identifier Source: secondary_id

VAC027.1

Identifier Type: -

Identifier Source: org_study_id