Correlates of protective immunity for Ebola vaccines: Implications for regulatory approval by the animal rule

Nancy J. Sullivan, Julie E. Martin, Barney S. Graham, Gary J. Nabel

Research output: Contribution to journalArticle

Abstract

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. The Food and Drug Administration has introduced the 'animal rule', to allow laboratory animal data to be used to show efficacy when human trials are not logistically feasible. 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.

Original languageEnglish (US)
Pages (from-to)393-400
Number of pages8
JournalNature Reviews Microbiology
Volume7
Issue number5
DOIs
StatePublished - 2009
Externally publishedYes

Fingerprint

Ebola Vaccines
Immunity
Vaccines
Laboratory Animals
Ebola Hemorrhagic Fever
Ebolavirus
United States Food and Drug Administration
Licensure
Research
Disease Outbreaks

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Medicine(all)

Cite this

Correlates of protective immunity for Ebola vaccines : Implications for regulatory approval by the animal rule. / Sullivan, Nancy J.; Martin, Julie E.; Graham, Barney S.; Nabel, Gary J.

In: Nature Reviews Microbiology, Vol. 7, No. 5, 2009, p. 393-400.

Research output: Contribution to journalArticle

Sullivan, Nancy J. ; Martin, Julie E. ; Graham, Barney S. ; Nabel, Gary J. / Correlates of protective immunity for Ebola vaccines : Implications for regulatory approval by the animal rule. In: Nature Reviews Microbiology. 2009 ; Vol. 7, No. 5. pp. 393-400.
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