Nature reviews. Microbiology
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Nat. Rev. Microbiol. · May 2009
ReviewCorrelates of protective immunity for Ebola vaccines: implications for regulatory approval by the animal rule.
Ebola virus infection is a highly lethal disease for which there are no effective therapeutic or preventive treatments. Several vaccines have provided immune protection in laboratory animals, but because outbreaks occur unpredictably and sporadically, vaccine efficacy cannot be proven in human trials, which is required for traditional regulatory approval. ⋯ In this Review, we describe immune correlates of vaccine protection against Ebola virus in animals. This research provides a basis for bridging the gap from basic research to human vaccine responses in support of the licensing of vaccines through the animal rule.