Recombinant proteins of a Pakistani strain of hepatitis E and their use in diagnostic methods and vaccines
AssigneeThe United States of America as represented by the Department of Health and Human Services
InventorsSergei A. Tsarev, Suzanne U. Emerson, Robert H. Purcell
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Abstract
A strain of hepatitis E virus from Pakistan (SAR-55) implicated in an epidemic of enterically transmitted non-A, non-B hepatitis, now called hepatitis E, is disclosed. The invention relates to the expression of the whole structural region of SAR-55, designated open reading frame 2 (ORF-2), in a eukaryotic expression system. The expressed protein is capable of forming HEV virus-like particles which can serve as an antigen in diagnostic immunoassays and as an immunogen or vaccine to protect against infection by hepatitis E.
Claims6
A method of detecting antibodies to hepatitis E virus in a biological sample, said method comprising:
- (a) contacting the sample with a purified recombinant hepatitis E virus open reading frame 2 protein having a molecular weight of approximately 55 kilodaltons as determined by polyacrylamide gel electrophoresis to form an immune complex with the antibodies;
- said protein being obtainable from the expression product of insect cells containing a recombinant baculovirus vector comprising a complete HEV ORF2 coding sequence;
- and
- (b) detecting the presence of the immune complex.
Dependencies are inferred from the claim text.