Malaria Clinical Trial
Official title:
Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults in a Malaria Endemic Area
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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