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 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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific titleSafety, 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 objectivesTo 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) studiedFebrile malaria
InterventionThis 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 typeBiological/Vaccine
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/02/2005
Completion date01/11/2006

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit6 Years
SexBoth
Target number of participants410
Key inclusion criteria1. Aged one to six years old, either sex
2. Resident in the study area
Key exclusion criteria1. 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 enrolment01/02/2005
Date of final enrolment21/03/2005

Locations

Countries of recruitment

  • Kenya

Study participating centre

Wellcome Trust Laboratories
Kilifi
-
Kenya

Sponsor information

University of Oxford (UK)
University/education

Nuffield Department of Medicine
John Radcliffe Hospital
University of Oxford
Headley Way
Oxford
OX3 9DU
England
United Kingdom

+44 (0)1865 222604
michael.halsey@admin.ox.ac.uk
http://www.ox.ac.uk/
ROR logo 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
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.

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