Major Neutralization Site of Hepatitis E Virus and Use of this Neutralization Site in Methods of Vaccination

Hepatitis E is endemic in many countries throughout the developing world, in particular on the continents of Africa and Asia. The disease generally affects young adults and has a very high mortality rate, up to 20%, in pregnant women. This invention relates to the identification of a neutralization site of hepatitis E virus (HEV) and neutralizing antibodies that react with it. The neutralization site is located on a polypeptide from the ORF2 gene (capsid gene) of HEV. This neutralization site was identified using a panel of chimpanzee monoclonal antibodies that are virtually identical to human antibodies. Since this neutralization site is conserved among genetically divergent strains of HEV, the neutralizing monoclonal antibodies may be useful in the diagnosis, treatment and/or prevention of hepatitis E. Furthermore, immunogens that encompass this neutralization site may be used in vaccination to effectively prevent, and/or reduce the incidence of HEV infection. Polypeptides containing this neutralization site may be useful in evaluating vaccine candidates for the production of neutralizing antibodies to HEV.


Suzanne Emerson (NIAID)  ➽ more inventions...

Robert Purcell (NIAID)  ➽ more inventions...

Intellectual Property:
U.S. Pat: 6,930,176 issued 2005-08-16
U.S. Pat: 1235862 issued 2007-06-13
US Application No. 60/167,490
US Application No. PCT/US00/32614

YH Zhou et al. A truncated ORF2 protein contains the most immunogenic site on ORF2: antibody responses to non-vaccine sequences following challenge of vaccinated and non-vaccinated macaques with HEV. Vaccine 2005 May 2;23(24):3157-3165. PubMed abs
DJ Schofield et al. Monoclonal antibodies that neutralize HEV recognize an antigenic site at the carboxyterminus of an ORF2 protein vaccine. Vaccine 2003 Dec 12;22(2):257-267. PubMed abs
YH Zhou et al. An ELISA for putative neutralizing antibodies to hepatitis E virus detects antibodies to genotypes 1,2,3,and 4. Vaccine 2004 Jun 30;22(20):2578-2585. PubMed abs

Collaboration Opportunity:

The NIAID Laboratory of Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize these antibodies or structures they interact with. For more information, please contact Robert H. Purcell, M.D., Co-chief, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 50 South Drive, Bldg. 50, Rm. 6523, Bethesda, MD 20892-8009; Phone (301) 496-5090; Fax (301) 402-0524.

Licensing Contact:
Peter Soukas, J.D.
Phone: 301-496-2644

OTT Reference No: E-043-2000-0
Updated: Jul 6, 2020