drugset / Trial / NCT01450293
AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area
Phase 1
Completed
72 enrolled
University of Oxford
European and Developing Countries Clinical Trials Partnership (EDCTP) · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the Gambia. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.
Timeline
- Start
- 2011-10
- Primary completion
- 2013-03
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AdCh63 ME-TRAP | Vaccine | 1e+10 vg | Intramuscular |
| Subject | AdCh63 ME-TRAP | Vaccine | 5e+10 vg | Intramuscular |
| Subject | MVA ME-TRAP | Vaccine | 1e+08 unknown | Intramuscular |