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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201208000404131 Date registered: 2012/08/17
TRIAL DESCRIPTION
Public title Phase 1/2b study of ChAd63 /MVA ME-TRAP in 5-17 month old Burkinabe infants and children
Official scientific title 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
Brief summary describing the background
and objectives of the trial
ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation is a highly promising candidate malaria vaccination strategy. The vaccination strategy shows potent immunogenicity in malaria-endemic populations, including infants and children, and has an excellent track record of safety. This trial ims to evaluate the efficacy of this vaccination strategy in infants and children living in malaria-endemic areas of Burkina Faso where malaria incidence and mortality are high.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Malaria ,
Purpose of the trial Prevention
Anticipated trial start date 2012-11-15
Actual trial start date
Anticipated date of last follow up 2015-08-28
Actual date of last follow up
Anticipated target sample size (number of participants) 730   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID
VAC050 Sponsor

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Day 0 ChAd63 ME-TRAP and Day 56 MVA ME-TRAP Day 0 ChAd63 ME-TRAP: 5 x 10 power 10 vp and Day 56 MVA ME-TRAP: 1 x 10 power 8 pfu Single intramuscular dose for ADCh63 ME-TRAP at Day 0 followed by a Single intramuscular dose of MVA ME-TRAP at Day 56 Participants will receive AdCh63 ME-TRAP IM followed by MVA ME-TRAP 365
Control group Rabies Vaccine Two doses of 0.5 mL Intramuscular Two doses at Day 0 and Day 56 Participants will receive 2 dose of rabies vaccines given intramuscularly 365 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1.Healthy infant/child aged 5-17 months at the time of first study vaccination 2.Informed consent of parent/guardian 3.Infant/child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up 1. Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. 2. Weight-for-age Z score of less than ¿3 or other clinical signs of malnutrition 3. History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation 4. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone. 5. Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator 6. Serum Creatinine concentration greater than 70 µmol/L, where judged to be clinically significant in the opinion of the investigator 7. Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator 8. Blood transfusion within one month of enrolment 9. Previous vaccination with experimental malaria vaccines. 10. Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine. 11. Current participation in another clinical trial, or within 12 weeks of this study. 12. 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 13. Known maternal HIV infection (No testing will be done by the study team) 14. Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5mg/kg/day. Inhaled and topical steroids are allowed.) 5 Months 17 Months Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2012/06/06 Comité d'Ethique pour la Recherche en Santé du Burkina Faso
Ethics Committee Address
Street address City Postal code Country
Ouagadougou 03 BP7009 Burkina Faso

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 At 6 Months after the last dose of vaccination
Secondary Outcome Duration of Protective efficacy against clinical malaria At 12 Months after the last dose of vaccination At 24 Months after the last dose of vaccination
Secondary Outcome Efficacy against asymptomatic P. falciparum infection At 6 Months after the last dose of vaccination At 12 Months after the last dose of vaccination At 24 Months after the last dose of vaccination
Secondary Outcome Efficacy against secondary case definitions of clinical malaria At 6 Months after the last dose of vaccination At 12 Months after the last dose of vaccination At 24 Months after the last dose of vaccination
Secondary Outcome Safety and reactogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation Adverse events from Day 0 to Day 93 Any time Serious adverse event occurs throughout the study duration

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre National de Recherche et de Formation sur le Paludisme (CNRFP)/ Unité de Recherche Clinique de Banfora (URC-B) 1483 Avenue Koumdayonré Ouagadougou BP 2208 Burkina Faso

FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Laan van Nieuw Oost Indië 334 The Hague Netherlands

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Old Road Campus Research Building, Oxford University Oxford Oxford OX3 7DQ United Kingdom University

COLLABORATORS
Name Street address City Postal code Country
UCAD Université Cheikh Anta Diop- Dakar-Fann B.P 5005 Senegal
MRC-The Gambia Atlantic Road Fajara Banjul P. O. Box 273 Gambia
KEMRI/WTRP Hospital grounds-off bofa road Kilifi Po Box 230 Kenya
Okairòs Srl Via dei Castelli Romani 22 00040 Pomezia Roma Italy
VSCR Kölblgasse 10 1030 Vienna 1030 Austria
European Vaccine Initiative (EVI) Universitäts Klinikum Im Neuenheimer Feld 326 - 3. OG Heidelberg 69120 Germany

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Sirima Sodiomon B. s.sirima.cnlp@fasonet.bf +226 70200444 +22650305220
Street address City Postal code Country Position / Affiliation
1487 Avenue Koumdayonré Ouagadougou 01 BP 2208 Burkina Faso Director Centre National de Recherche et de Formation sur le Paludisme (CNRFP)
Role Name Email Phone Fax
Scientific Enquiries Dr Ouédraogo N. Issa issanebie.cnlp@fasonet.bf +22670265987 +22650305220
Street address City Postal code Country Position / Affiliation
1487 Avenue Koumdayonré Ouagadougou 01 BP 2208 Burkina Faso Head Immunology Lab
Role Name Email Phone Fax
Public Enquiries Dr Tiono Alfred B. t.alfred@fasonet.bf +22670285726 +22650305220
Street address City Postal code Country Position / Affiliation
1487 Avenue Koumdayonré Ouagadougou 01 BP 2208 Burkina Faso Head Public Health Department, CNRFP