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

Sponsor

European Malaria Vaccine Initiative (Other)

Overall Status

Completed

CT.gov ID

NCT00374998

Collaborator

University of Oxford (Other), Wellcome Trust (Other)

Enrollment

Location

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria, Falciparum Malaria	Biological: FP9-PP (FP9 polyprotein) Biological: MVA-PP (Modified Virus Ankara polyprotein)	Phase 1

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:

Examine safety
Examine immunogenicity
Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study (VAC027.2)

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Apr 1, 2006

Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

T-cell immunogenicity (prime-boost groups) []
Humoral immunogenicity (prime-boost groups) []
Gene expression (prime-boost groups) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford	Oxford		United Kingdom	OX3 7LJ

Sponsors and Collaborators

European Malaria Vaccine Initiative
University of Oxford
Wellcome Trust

Investigators

Principal Investigator: Adrian VS Hill, MA, BM BCh, DPhil, DM, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00374998

Other Study ID Numbers:

VAC027.1
EudraCT number: 2004-002424-17
EMVI trial identifier: PP_1_04

First Posted:

Sep 12, 2006

Last Update Posted:

Mar 1, 2007

Last Verified:

Feb 1, 2007

Keywords provided by , ,

Malaria

Vaccine

Prime-boost

Additional relevant MeSH terms:

Malaria

Malaria, Falciparum

Study Results

No Results Posted as of Mar 1, 2007