The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50. The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
AdCh63 ME-TRAP 1x10\^10 vp intramuscularly, MVA ME-TRAP 2x10\^8 pfu intramuscularly
AdCh63 ME-TRAP 5x10\^10 vp intramuscularly, MVA ME-TRAP 2x10\^8 pfu intradermal
KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast
Kilifi, Kenya
Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.
To assess safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by recording local and systemic solicited and unsolicited adverse events
Time frame: Participants will be followed for the duration of the study, an expected average of 12 months
Immunogenicity of vaccines
To evaluate the immunogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by assessing induced antibody and T cell response to the vaccine insert.
Time frame: Participants will be followed for the duration of the study, an expected average of 12 months
Immunogenicity of Vaccines
To compare the use of intra-muscular and intra-dermal MVA ME-TRAP
Time frame: Participants will be followed for the duration of the study, an expected average of 12 months
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