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 and adult volunteers 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
52
AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later
AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later
AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 1 x 10\^8 pfu IM 8 weeks later
Dr Kalifa Bojang
Banjul, The Gambia
Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP
To assess the safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia 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 a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP
To assess the immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia 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
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AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later
HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 1 x 10\^8 pfu IM 8 weeks later
AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later
HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later