Malaria
Conditions
Interventions
Day 0 ChAd63 ME-TRAP and Day 56 MVA ME-TRAP
Rabies Vaccine
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Protective efficacy against clinical malaria;Efficacy against asymptomatic P. falciparum infection;Efficacy against secondary case definitions of clinical malaria;Safety and reactogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation | — |
Countries
Burkina Faso
Contacts
Public ContactTiono Alfred B.
Head Public Health Department, CNRFP
Outcome results
None listed