Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP - Full Text View

Purpose

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	Intervention	Phase
Malaria, Falciparum Malaria	Biological: FP9-PP (FP9 polyprotein) Biological: MVA-PP (Modified Virus Ankara polyprotein)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria

U.S. FDA Resources

Further study details as provided by European Malaria Vaccine Initiative:

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)

Estimated Enrollment:	35
Study Start Date:	April 2006
Estimated Study Completion Date:	January 2007

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)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374998

Locations

United Kingdom
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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00374998 History of Changes
Other Study ID Numbers:	VAC027.1, EudraCT number: 2004-002424-17, EMVI trial identifier: PP_1_04
Study First Received:	September 10, 2006
Last Updated:	February 28, 2007
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by European Malaria Vaccine Initiative:

Malaria
Vaccine
Prime-boost

Additional relevant MeSH terms:

Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 22, 2013