- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01635647
A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso
February 12, 2016 updated by: University of Oxford
A Phase 1/2b Double Blind Randomised Controlled Trial of the Efficacy, Safety and Immunogenicity of Heterologous Prime-boost Immunisation With the Candidate Malaria Vaccines ChAd63 ME-TRAP and MVA ME-TRAP in 5-17 Month Old Burkinabe Infants and Children
Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments.
It is a leading candidate vaccination strategy against malaria.
In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia.
The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown.
In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria.
With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas.
The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
730
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ouagadougou, Burkina Faso, BP 2208
- Centre for Clinical Vaccinology and 1. Centre National de Recherche et de Formation sur le Paludisme (CNRFP)/ Unité de Recherche Clinique de Banfora (URC-B)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy infant/child aged 5-17 months at the time of first study vaccination
- Informed consent of parent/guardian
- Infant / child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up
Exclusion Criteria:
- Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- Weight-for-age Z score of less than -3 or other clinical signs of malnutrition
- History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone.
- Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
- Serum Creatinine concentration greater than 70 µmol/L, where judged to be clinically significant in the opinion of the investigator
- Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
- Blood transfusion within one month of enrolment
- Previous vaccination with experimental malaria vaccines.
- Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine.
- Current participation in another clinical trial, or within 12 weeks of this study.
- Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor quality data
- Known maternal HIV infection (No testing will be done by the study team)
- Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ChAd63 ME-TRAP and MVA ME-TRAP
ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation
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ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 1 x 10^8 pfu heterologous prime-boost immunisation
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Placebo Comparator: Rabies vaccine
2 x 2.5IU Verorab
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Two doses eight weeks apart into anterolateral thigh. 2 x 2.5IU Verorab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first episode of malaria meeting the primary case definition of clinical malaria episode
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Protective efficacy against clinical malaria
Time Frame: 12 and 24 months
|
To assess the protective efficacy against clinical malaria of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 12 and 24* months after the last vaccination.
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12 and 24 months
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Efficacy against asymptomatic P. falciparum infection
Time Frame: 6, 12 and 24 months
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To assess the protective efficacy against asymptomatic P. falciparum infection of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, 6, 12 and 24* months after the last vaccination
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6, 12 and 24 months
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Efficacy against secondary case definitions of clinical malaria
Time Frame: 6, 12 and 24 months
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To assess the protective efficacy against secondary case definitions of clinical malaria of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 6, 12 and 24 months after the last vaccination
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6, 12 and 24 months
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Safety Objective
Time Frame: 6, 12 and 24 months
|
To assess the safety and reactogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 6, 12 and 24 months after the last vaccination.
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6, 12 and 24 months
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Immunogenicity Objectives
Time Frame: 24 months
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
July 3, 2012
First Submitted That Met QC Criteria
July 6, 2012
First Posted (Estimate)
July 9, 2012
Study Record Updates
Last Update Posted (Estimate)
February 15, 2016
Last Update Submitted That Met QC Criteria
February 12, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAC050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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