Patent ID: 7476530
Filing Date: 2009-01-13
Classification: A61K

Abstract:
1. A method for selecting mucosa adherent strains of Mycobacterium avium subspecies paratuberculosis (MAP) in the development of an oral MAP vaccine, the steps comprising: a) screening and identifying a live wild MAP isolate with binding affinity to calf gastrointestinal mucosa in-vitro, b) altering the live wild MAP isolate to achieve a mucosal adherent, altered MAP isolate by a method selected from the group consisting of: serial passage of the isolate in-vitro, serial passage of the isolate in-vitro in the presence of mutagens, serial passage in a host animal, and genetic modification of virulence to effect genomic expression, c) re-screening and selecting an altered MAP isolate retaining the ability to bind to gastrointestinal mucosa, d) demonstrating the selected altered MAP isolate is attenuated relative to the live wild MAP isolate in-vivo, e) selecting an altered MAP isolate for oral administration that stimulates a predominant TH-1 immune response, the TH-1 immune response differing from the live wild MAP isolate, said altered MAP isolate having an adherence colony forming unit (CFU) to disintegrations per minute (DPM) ratio (CFU/DPM) that is statistically significant higher when compared with other altered isolates, f) orally administering to a host animal the selected altered MAP isolate that elicits a predominant TH-1 immune response in a dosage and frequency necessary to illicit a local MAP TH-1 response, along with a specific IgG immunoglobulin, a specific IgA immunoglobulin or cell-mediated immunity, g) testing the altered MAP strains for the ability to preclude wild-type MAP from adhering to host animal gastrointestinal mucosa against mucosal challenge with wild-type MAP in a host animal.