Use of the FDA Animal Rule for licensure of Ebola and Marburg virus vaccines requires a detailed understanding of vaccine-induced immune response since correlates of immunity will replace efficacy studies that would otherwise be provided to support vaccine licensure. An immune correlate of protection against infection must first be identified in an animal model that reasonably represents disease pathogenesis in humans. Vaccine efficacy is tested in animals, and the immune response that correlates best with survival is identified. Subsequent immunogenicity studies in human subjects are designed to test whether the vaccine can induce similar responses in humans.

Project Start
Project End
Budget Start
Budget End
Support Year
8
Fiscal Year
2012
Total Cost
$901,608
Indirect Cost
City
State
Country
Zip Code
Fausther-Bovendo, Hugues; Mulangu, Sabue; Sullivan, Nancy J (2012) Ebolavirus vaccines for humans and apes. Curr Opin Virol 2:324-9
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Hensley, Lisa E; Mulangu, Sabue; Asiedu, Clement et al. (2010) Demonstration of cross-protective vaccine immunity against an emerging pathogenic Ebolavirus Species. PLoS Pathog 6:e1000904
Geisbert, Thomas W; Bailey, Michael; Geisbert, Joan B et al. (2010) Vector choice determines immunogenicity and potency of genetic vaccines against Angola Marburg virus in nonhuman primates. J Virol 84:10386-94