ISOLATED AND PURIFIED PEPTIDE, RECOMBINANT FUSION PROTEIN, VECTOR, HOST CELL, METHOD FOR GENERATING PEPTIDE, VACCINE COMPOSITION, METHOD FOR DETERMINING THE PRESENCE OR ABSENCE OF HEV ANTIBODIES, DIAGNOSTIC TEST KIT, AND DIAGNOSTIC REAGENT.

摘要

"New hev antigenic peptide and methods". The present invention relates to a highly immunoreactive viral peptide, pe2, which is derived from the carboxy terminal regions of the hepatitis virus genome (hev) orf2 region. A unique feature of the new pe2 peptide is that it has conformational antigenic determinants that are only exposed when the peptide monomer associates with one another through non-covalent interactions to naturally form homodimers. The new pe2 peptide has been proven to be highly reactive with sera from patients with past and current hev infection, suggesting that the homodimer may mimic certain structural characteristics of the hev capsid protein. In addition, the antigenic activity of the pe2 peptide is strictly conformational in nature and thus exhibits immunochemical reactivity only when the peptide exists in dimeric form. consequently, antigenic activity is lost upon dissociation of dimers, but activity is restored when monomers reassociate to form dimers. In addition, the diagnostic methods useful in detecting and diagnosing hev infection, and the use of an effective vaccine composition in preventing hepatitis virus infection and in which the new pe2 peptide is used, are also described.