Oral vaccinia formulation

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Virus or component thereof

Reexamination Certificate

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C424S199100, C424S400000

Reexamination Certificate

active

06960345

ABSTRACT:
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 formulation 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.

REFERENCES:
patent: 5676950 (1997-10-01), Small et al.
patent: 6090925 (2000-07-01), Woiszwillo et al.
patent: 2003/0059471 (2003-03-01), Compton et al.
patent: 2003/0059474 (2003-03-01), Scott et al.
patent: 2003/0068385 (2003-04-01), Moyer et al.
patent: WO99/07869 (1999-02-01), None
Wyatt et al. (PNAS 101:4590-4595, 2004).
Earl et al. (Nature 428:182-185, 2004).
Belyakov et al. (PNAS 100:9458-9463, 2003).
Nechaeva (Expert Review of Vaccines 1(3):385-97, 2002).

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