Contact information
Type
Scientific
Primary contact
Mr Philip Bejon
ORCID ID
Contact details
Wellcome Trust Laboratories
Kilifi KEMRI-Wellcome Trust Collaborative Programme
PO Box 80108 - 230
Kilifi
-
Kenya
+254 (0)41 522063/522535/435/044
pbejon@kilifi.kemri-wellcome.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
073597
Study information
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
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Febrile malaria
Intervention
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.
Intervention type
Drug
Phase
Phase II/III
Drug names
FP9 ME-TRAP, MVA ME-TRAP
Primary outcome measures
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 measures
No secondary outcome measures
Overall trial start date
01/02/2005
Overall trial end date
01/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged one to six years old, either sex
2. Resident in the study area
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
410 - recruitment ends on the 21st March 2005
Participant 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
Recruitment start date
01/02/2005
Recruitment end date
01/11/2006
Locations
Countries of recruitment
Kenya
Trial participating centre
Wellcome Trust Laboratories
Kilifi
-
Kenya
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Nuffield Department of Medicine
John Radcliffe Hospital
University of Oxford
Headley Way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 222604
michael.halsey@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
London School of Hygiene and Tropical Medicine (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Wellcome Trust (UK) (grant ref: 073597)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17053830
Publication citations
-
Results
Bejon P, Mwacharo J, Kai O, Mwangi T, Milligan P, Todryk S, Keating S, Lang T, Lowe B, Gikonyo C, Molyneux C, Fegan G, Gilbert SC, Peshu N, Marsh K, Hill AV, A phase 2b randomised trial of the candidate malaria vaccines FP9 ME-TRAP and MVA ME-TRAP among children in Kenya., PLoS Clin Trials, 2006, 1, 6, e29, doi: 10.1371/journal.pctr.0010029.