Infectious Hepatitis E Virus Genotype 3 Recombinants – Prospective Vaccine Candidates and Vector System

This technology is a recombinant, infectious genotype 3 Hepatitis E virus (HEV) that has been adapted to grow in cell culture and can potentially be used to develop vaccines against HEV or as a vector system to insert exogenous sequences into HEV. The virus (strain Kernow-C1, genotype 3) originated from a chronically infected human subject and was adapted to grow in human hepatoma cells. The adapted virus is unique in that it contains an insertion of a portion of a human ribosomal protein in Open Reading Frame 1 of the virus. Desired exogenous sequences can potentially be placed in lieu of the insert without inactivating the virus.

Infection by HEV is a relevant health issue in a number of developing countries and is also an emerging food-borne disease of industrialized countries. Genotype 1 and 2 infections are found exclusively in humans while genotype 3 and 4 viruses have been found not only in humans, but also swine, deer, mongoose, cattle, and rabbits. In particular, genotype 3 and 4 viruses are ubiquitously found in swine and undercooked pork is thought to be one of the sources of infection for cases of human infections in industrialized countries.

Potential Commercial Applications: Competitive Advantages:
  • An infectious, recombinant HEV genotype 3 cDNA clone that could potentially be developed into a vaccine candidate.
  • HEV Vector Platform – Desired exogenous sequences can be inserted into the viral genome without inactivating the virus.
  • Most of the HEV vaccines under development are subunit based while the subject technology could potentially be developed into a live, attenuated virus based vaccine.
  • Ability to insert exogenous sequences into the viral genome without inactivating the virus makes this subject technology a potential HEV based vector platform.

Priyanka Shukla (NIAID)
Suzanne Emerson (NIAID)
Robert Purcell (NIAID)
Hanh Nguyen (NIAID)

Intellectual Property:
PCT Application No. PCT/US2012/020830
US Application No. 13/978,839

Collaboration Opportunity:

The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize hepatitis E virus vaccines. For collaboration opportunities, please contact Maryann Puglielli, Ph.D., J.D. at 301-451-6863 or

Licensing Contact:
Kevin Chang , Ph.D.
NIH Office of Technology Transfer
Phone: 301-435-5018

OTT Reference No: E-074-2011/2

Updated: Mar-21-2013