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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
ISRCTN ISRCTN88335123
DOI 10.1186/ISRCTN88335123
ClinicalTrials.gov identifier
EudraCT number
Public title Safety, immunogenicity and efficacy against febrile malaria of the candidate vaccines FP9 ME-TRAP and MVA ME-TRAP for children in an endemic area
Scientific title 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
Acronym N/A
Serial number at source 073597
Study hypothesis 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
Lay summary Not provided at time of registration
Ethics approval 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)
Study design Randomised controlled trial
Countries of recruitment Kenya
Disease/condition/study domain Febrile malaria
Participants - inclusion criteria 1. Aged one to six years old, either sex
2. Resident in the study area
Participants - exclusion criteria 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
Anticipated start date 01/02/2005
Anticipated end date 01/11/2006
Status of trial Completed
Patient information material
Target number of participants 410 - recruitment ends on the 21st March 2005
Interventions 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.
Primary outcome measure(s) 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
Secondary outcome measure(s) No secondary outcome measures
Sources of funding 1. London School of Hygiene and Tropical Medicine (UK)
2. The Wellcome Trust (UK) (grant ref: 073597)
Trial website
Publications 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17053830
Contact name Mr  Philip  Bejon
  Address Wellcome Trust Laboratories
Kilifi KEMRI-Wellcome Trust Collaborative Programme
PO Box 80108 - 230
  City/town Kilifi
  Zip/Postcode -
  Country Kenya
  Tel +254 (0)41 522063/522535/435/044
  Email pbejon@kilifi.kemri-wellcome.org
Sponsor University of Oxford (UK)
  Address Nuffield Department of Medicine
John Radcliffe Hospital
University of Oxford
Headley Way
  City/town Oxford
  Zip/Postcode OX3 9DU
  Country United Kingdom
  Tel +44 (0)1865 222604
  Email michael.halsey@admin.ox.ac.uk
  Sponsor website: http://www.ox.ac.uk/
Date applied 13/09/2005
Last edited 20/03/2013
Date ISRCTN assigned 14/10/2005
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