Oral smallpox vaccine production and methods to evaluate safety, efficacy, and potency of orally delivered vaccine

Methods of administering the DVV to a host under circumstances that result in delivery of said vaccine via the oral cavity such that the virus can enter the alimentary tract at multiple sites, including the oral cavity and small intestine, and deliver virus that can stimulate host immunity;

Methods of packaging and delivery such that said virus will be protected from degradation and taken in the alimentary tract at multiple sites;

Methods of propagation such that a live recombinant vaccinia vaccine capable of stimulating a host immune response against the vaccinia virus and related poxviruses, including smallpox virus;

Said immune response of the host can be measured by methods and tools developed as part of this invention and comprising humoral production of antibodies, including serum IgG, as a means of host protection;

Said immune response of the host being stimulated via the mucosal immune system of the alimentary tract as part of this invention and comprising mucosal production of antibodies, including mucosal IgA, as a means of host protection;

A further means of protection of the host in which there is an immune response measured by methods, such as specific cell-mediated responses that lead to cell stimulation of DNA synthesis, cytokine production or the killing of virus-infected cells, which indicate there is cell-mediated immunity;

A method whereby the excipients used in formulation or packaging of the vaccine permits multi-site delivery down the alimentary tract and into the host circulation;

A method which allows production of a multivalent or pooled vaccine that targets smallpox and can include other infectious agents or the products of infectious agents in the vaccine;

The methods and claims of 1-25 wherein the vaccine is prepared to have a long shelf life due to the methods of manufacturing.

The methods and claims of 1-26 where a multivalent vaccine is prepared that has efficacy in protecting humans against infectious agents or immunogens in addition to smallpox.

The methods and claims of 1-27 where a multivalent vaccine is prepared that has efficacy in protecting animals against infectious agents or immunogens in addition to poxviruses.