Malaria Clinical Trial
Official title:
Efficacy Study of ChAd63-MVA ME-TRAP Prime-boost Vaccination Against Plasmodium Falciparum Infection
Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials
become more widely available. However, transmission still persists and it appears that
additional control measures are required. The leading malaria vaccine candidate in
development is RTS,S which has efficacy against clinical malaria measured at 30-50% in the
field. This partial protection might be enhanced by combination with other components. The
other vaccination approach that has produced repeatable efficacy in humans is the use of
viral vectors to induce T cell responses. Previous attempts with this vaccine approach have
been effective in challenge studies in Oxford, but ineffective in the field, probably
because of reduced immunogenicity with previous vector platforms.
Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity
by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified
vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with
thrombospondin- related adhesion protein (ME-TRAP).
The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and
partial protection in 5 out of 14 volunteers in challenge studies.
The investigators propose a Phase 2b study of 120 healthy adult men in Senegal. The
investigators will assess the efficacy and further evaluate the immunogenicity and safety
profile of the vaccine regimen. The investigators also intend to assess the correlates of
efficacy and natural immunity.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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