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ISRCTN
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ISRCTN05221133
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled double-blind trial of DNA ME-TRAP/MVA ME-TRAP against malaria infection in Gambians aged 15 to 45
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Scientific title
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Acronym
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VAC020
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Serial number at source
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060147
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Study hypothesis
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A randomised, controlled trial of Deoxyribonucleic Acid (DNA) Multiple Epitope (ME)-Thrombospondin Related Adhesion Protein (TRAP)/Modified Vaccinia virus Ankara (MVA) ME-TRAP in a rural part of Gambia to explore whether this vaccine combination could provide protection against natural P. falciparum infection.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Gambia
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Disease/condition/study domain
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Plasmodium falciparum malaria
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Participants - inclusion criteria
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1. 372 Healthy Gambian men aged 15 to 45
2. Resident in villages in the North Bank Division
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Participants - exclusion criteria
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No exclusion criteria provided at time of registration
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Anticipated start date
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01/07/2002
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Anticipated end date
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01/12/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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372
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Interventions
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Intervention: Deoxyribonucleic Acid (DNA) Multiple Epitope (ME)-Thrombospondin Related Adhesion Protein (TRAP) malaria vaccination followed by Modified Vaccinia virus Ankara (MVA) ME-TRAP malaria vaccination
Control: Chiron Rabipur rabies vaccine
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Primary outcome measure(s)
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1. Vaccine safety
2. Immunogenicity
3. Time to first P. falciparum infection
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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1. The Wellcome Trust (UK) (grant ref: 060147)
2. Gates' Partnership at London School of Hygiene and Tropical Medicine (UK)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15526058
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Contact name
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Dr
Vasee
Moorthy
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Address
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6290 Montrose Road
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City/town
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Rockville
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Zip/Postcode
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20814
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Country
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United States of America
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Sponsor
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London School of Hygiene and Tropical Medicine (UK)
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Address
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Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Date applied
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01/09/2004
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Last edited
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07/09/2007
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Date ISRCTN assigned
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05/10/2004
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