This is an open label phase I study, to assess the safety and immunogenicity of novel schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP. These vaccines have been evaluated previously in a number of clinical trials proved to be safe and capable of inducing protective cellular immune response following challenge with the parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of the seven regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
39
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, United Kingdom
Vaccine Safety
To assess the safety of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7
Time frame: Participants will be followed for the duration of the study, an expected average of 21 months
Vaccine immunogenicity
To assess the immunogenicity of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7
Time frame: Participants will be followed for the duration of the study, an expected average of 21months
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