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ISRCTN
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ISRCTN88335123
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ClinicalTrials.gov identifier
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Public title
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Safety, immunogenicity and efficacy against febrile malaria of the candidate vaccines FP9 ME-TRAP and MVA ME-TRAP for children in an endemic area
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Scientific title
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Safety, immunogenicity and efficacy against febrile malaria of the candidate vaccines FP9 ME-TRAP and MVA ME-TRAP for children in an endemic area: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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073597
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Study hypothesis
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To compare the following outcome measures in children immunised with a control immunisation (rabies vaccine) or FP9:ME-TRAP MVA:ME-TRAP during two three to four month surveillance periods spanning the malaria transmission seasons:
1. Rates of development of febrile malaria and proportions of children with episodes of febrile malaria
2. The incidence of solicited local side-effects at the site of injection and systemic side-effects in the days following immunisation
3. The immediate effector T cell response and long-term memory T cell response after vaccination
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Lay summary
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Ethics approval
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1. Kenyan Medical Research Institute National Ethical Review Committee gave approval on 23rd November 2004 (ref: SSC Protocol 915)
2. Central Office for Research Ethics Committees (COREC) gave approval on 9th February 2005 (ref: 05/Q1604/9)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Kenya
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Disease/condition/study domain
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Febrile malaria
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Participants - inclusion criteria
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1. Aged one to six years old, either sex
2. Resident in the study area
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Participants - exclusion criteria
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1. Clinically significant skin disorder, allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, severe malnutrition (mid-upper arm circumference less than 11 cm)
2. History of splenectomy
3. Serum creatinine concentration above the age related normal range in Kilifi
4. Serum alanine aminotransferase (ALT) concentration above the normal range in Kilifi
5. Clinically significant anaemia (i.e. with symptoms of limited exercise capacity, or signs of a high cardiac output state; large volume pulse, heaving cardiac apex beat, resting tachycardia)
6. Blood transfusion within one month of the beginning of the study
7. History of vaccination with previous experimental malaria vaccines
8. Administration of any other vaccine or immunoglobulin within two weeks before vaccination
9. Current participation in another clinical trial, or within 12 weeks of this study
10. Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial
11. Likelihood of travel away from the study area
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Anticipated start date
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01/02/2005
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Anticipated end date
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01/11/2006
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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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410 - recruitment ends on the 21st March 2005
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Interventions
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This study will evaluate the efficacy of the regime of FP9:ME-TRAP (attenuated Fowlpox virus recombinant for ME-TRAP) followed by MVA:ME-TRAP (modified Vaccinia Ankara recombinant for ME-TRAP) in one to six year old children in Kilifi District, Kenya, during two three to four month surveillance periods spanning the malaria transmission seasons. The trial will be randomised and double blind, using rabies vaccine as control. We will screen 450 children, aiming to recruit 410 children to be randomised in a 1:1 ratio to active or control vaccinations.
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Primary outcome measure(s)
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1. Safety and immunogenicity data will be evaluated by clinical assessments and blood tests
2. Subsequent weekly follow up will allow blood film examinations for all febrile children
3. Rates of development of febrile malaria and proportions of children with episodes of febrile malaria will be compared between groups to determine efficacy
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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. London School of Hygiene and Tropical Medicine (UK)
2. The Wellcome Trust (UK) (grant ref: 073597)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17053830
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Contact name
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Mr
Philip
Bejon
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Address
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Wellcome Trust Laboratories
Kilifi KEMRI-Wellcome Trust Collaborative Programme
PO Box 80108 - 230
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City/town
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Kilifi
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Zip/Postcode
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-
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Country
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Kenya
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Tel
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+254 (0)41 522063/522535/435/044
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Email
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pbejon@kilifi.kemri-wellcome.org
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Sponsor
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University of Oxford (UK)
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Address
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Nuffield Department of Medicine
John Radcliffe Hospital
University of Oxford
Headley Way
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Tel
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+44 (0)1865 222604
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Email
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michael.halsey@admin.ox.ac.uk
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Sponsor website:
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http://www.ox.ac.uk/
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Date applied
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13/09/2005
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Last edited
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22/01/2009
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Date ISRCTN assigned
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14/10/2005
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