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

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.

Study Overview

• Status: Completed
• Conditions: Malaria; Malaria, Falciparum
• Intervention / Treatment: Biological: FP9-PP (FP9 polyprotein); Biological: MVA-PP (Modified Virus Ankara polyprotein)

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 Type: Interventional
• Enrollment: 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 7LJ
    • Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Immediate reactogenicity
Adverse events occurring before the end of the trial
Biological safety (haematological and biochemical indices)

Secondary Outcome Measures

Outcome Measure
T-cell immunogenicity (prime-boost groups)
Humoral immunogenicity (prime-boost groups)
Gene expression (prime-boost groups)

Collaborators and Investigators

• Sponsor: European Malaria Vaccine Initiative
• Collaborators: University of Oxford; Wellcome Trust

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Study Completion: January 1, 2007

Study Registration Dates

• First Submitted: September 10, 2006
• First Submitted That Met QC Criteria: September 10, 2006
• First Posted (ESTIMATE): September 12, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): March 1, 2007
• Last Update Submitted That Met QC Criteria: February 28, 2007
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Keywords: Malaria; Vaccine; Prime-boost
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Malaria, Falciparum
• Other Study ID Numbers: VAC027.1; EudraCT number: 2004-002424-17; EMVI trial identifier: PP_1_04