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 |
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DOI | https://doi.org/10.1186/ISRCTN88335123 |
Secondary identifying numbers | 073597 |
- Submission date
- 13/09/2005
- Registration date
- 14/10/2005
- Last edited
- 05/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Philip Bejon
Scientific
Scientific
Wellcome Trust Laboratories
Kilifi KEMRI-Wellcome Trust Collaborative Programme
PO Box 80108 - 230
Kilifi
-
Kenya
Phone | +254 (0)41 522063/522535/435/044 |
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pbejon@kilifi.kemri-wellcome.org |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
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 |
Study objectives | 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(s) | 1. Kenyan Medical Research Institute National Ethical Review Committee, 23/11/2004, ref: SSC Protocol 915 2. Central Office for Research Ethics Committees (COREC), 09/02/2005, ref: 05/Q1604/9 |
Health condition(s) or problem(s) studied | 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 | Biological/Vaccine |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | |
Primary outcome measure | 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 study start date | 01/02/2005 |
Completion date | 01/11/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 1 Year |
Upper age limit | 6 Years |
Sex | Both |
Target number of participants | 410 |
Key inclusion criteria | 1. Aged one to six years old, either sex 2. Resident in the study area |
Key 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 |
Date of first enrolment | 01/02/2005 |
Date of final enrolment | 21/03/2005 |
Locations
Countries of recruitment
- Kenya
Study participating centre
Wellcome Trust Laboratories
Kilifi
-
Kenya
-
Kenya
Sponsor information
University of Oxford (UK)
University/education
University/education
Nuffield Department of Medicine
John Radcliffe Hospital
University of Oxford
Headley Way
Oxford
OX3 9DU
England
United Kingdom
Phone | +44 (0)1865 222604 |
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michael.halsey@admin.ox.ac.uk | |
Website | http://www.ox.ac.uk/ |
https://ror.org/052gg0110 |
Funders
Funder type
University/education
London School of Hygiene and Tropical Medicine (UK)
No information available
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 20/10/2006 | Yes | No |
Editorial Notes
05/03/2019: Internal review.