This invention relates to methods and systems for generating a safe and effective oral
smallpox vaccine for humans using a genetically defective strain of
vaccinia virus to confer
immunity following oral delivery of the vaccine. This invention is one that expands on current use of
vaccinia virus propagation developed for
gene therapy applications, and pharmaceuticals and nutraceuticals packaging and formualtion technologies. The vaccine invention can be delivered as a
live virus with the ability to express viral proteins but unable to achieve complete, lytic
virus replication, or it may be derived from such a virus, contain additional immunogens, or be delivered as
viral antigens. Furthermore, the invention establishes innovative methods for formulation and packaging and for preclinical testing of the vaccine invention for safety,
efficacy and
potency with the use of human intestinal and other test cells and
diagnostic test systems and kits.