Condition category
Infections and Infestations
Date applied
13/09/2005
Date assigned
14/10/2005
Last edited
20/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ox.ac.uk/

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

  1. 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.

Additional files

Editorial Notes