Approach to Strain Selection and the Propagation of Viral Stocks for Venezuelan Equine Encephalitis Virus Vaccine Efficacy Testing under the Animal Rule

Janice M. Rusnak, Pamela J. Glass, Scott Weaver, Carol L. Sabourin, Andrew M. Glenn, William Klimstra, Christopher S. Badorrek, Farooq Nasar, Lucy A. Ward

Research output: Contribution to journalArticle

Abstract

Licensure of a vaccine to protect against aerosolized Venezuelan equine encephalitis virus (VEEV) requires use of the U.S. Food and Drug Administration (FDA) Animal Rule to assess vaccine efficacy as human studies are not feasible or ethical. An approach to selecting VEEV challenge strains for use under the Animal Rule was developed, taking into account Department of Defense (DOD) vaccine requirements, FDA Animal Rule guidelines, strain availability, and lessons learned from the generation of filovirus challenge agents within the Filovirus Animal Nonclinical Group (FANG). Initial down-selection to VEEV IAB and IC epizootic varieties was based on the DOD objective for vaccine protection in a bioterrorism event. The subsequent down-selection of VEEV IAB and IC isolates was based on isolate availability, origin, virulence, culture and animal passage history, known disease progression in animal models, relevancy to human disease, and ability to generate sufficient challenge material. Methods for the propagation of viral stocks (use of uncloned (wild-type), plaque-cloned, versus cDNA-cloned virus) to minimize variability in the potency of the resulting challenge materials were also reviewed. The presented processes for VEEV strain selection and the propagation of viral stocks may serve as a template for animal model development product testing under the Animal Rule to other viral vaccine programs. This manuscript is based on the culmination of work presented at the "Alphavirus Workshop" organized and hosted by the Joint Vaccine Acquisition Program (JVAP) on 15 December 2014 at Fort Detrick, Maryland, USA.

Original languageEnglish (US)
JournalViruses
Volume11
Issue number9
DOIs
StatePublished - Aug 31 2019

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Venezuelan Equine Encephalitis Viruses
Vaccines
United States Food and Drug Administration
Animal Models
Viral Vaccines
Alphavirus
Bioterrorism
Licensure
Virulence
Disease Progression
Complementary DNA
Joints
History
Guidelines
Viruses
Education

Keywords

  • Animal Rule
  • cDNA cloned virus
  • strain selection
  • vaccine
  • Venezuelan equine encephalitis virus
  • virus stock propagation

ASJC Scopus subject areas

  • Infectious Diseases
  • Virology

Cite this

Approach to Strain Selection and the Propagation of Viral Stocks for Venezuelan Equine Encephalitis Virus Vaccine Efficacy Testing under the Animal Rule. / Rusnak, Janice M.; Glass, Pamela J.; Weaver, Scott; Sabourin, Carol L.; Glenn, Andrew M.; Klimstra, William; Badorrek, Christopher S.; Nasar, Farooq; Ward, Lucy A.

In: Viruses, Vol. 11, No. 9, 31.08.2019.

Research output: Contribution to journalArticle

Rusnak, Janice M. ; Glass, Pamela J. ; Weaver, Scott ; Sabourin, Carol L. ; Glenn, Andrew M. ; Klimstra, William ; Badorrek, Christopher S. ; Nasar, Farooq ; Ward, Lucy A. / Approach to Strain Selection and the Propagation of Viral Stocks for Venezuelan Equine Encephalitis Virus Vaccine Efficacy Testing under the Animal Rule. In: Viruses. 2019 ; Vol. 11, No. 9.
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