Human adenovirus 5-vectored Plasmodium falciparum NMRC-M3V-Ad-PfCA vaccine encoding CSP and AMA1 is safe, well-tolerated and immunogenic but does not protect against controlled human malaria infection.

In contrast to these Ad-alone studies, the first clinical assessment of a DNA prime/Ad boost regimen using CSP and AMA1 16 induced sterile immunity in four of 15 research subjects (27% protection overall, 40% protection in the ten Ad5 seronegative research subjects) that was statistically significantly associated with IFN-γ ELISpot and CD8 + T cell responses to one of the vaccine antigens, AMA1, and showed a trend for CSP.

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Moreover, despite their lack of greater magnitude, the IFN-γ responses in DNA/Ad were statistically significantly associated with sterile protection (AMA1) or showed a strong trend (CSP).

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