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Use of cross-protection to identify novel vaccine candidates for infectious agents

Use of cross-protection to identify novel vaccine candidates for infectious agents description/claims

The present application is a divisional of Ser. No. 10/762,241, filed Jan. 23, 2004 (allowed), which claims benefit of U.S. Provisional Application No. 60/442,072, filed Jan. 24, 2003, the entire contents of each of which is hereby incorporated by reference.

The general field of the invention is the development of sub-cellular vaccines that induce immunity to infectious agents. More particularly, the invention relates to the identification of novel vaccine candidates (with logical extensions to other infectious agents such as other bacteria, fungi, yeast, viruses or parasites), quality assurance for vaccine batches, assessment of protection in vaccinated animals and the identification of the infecting agent in vaccinates.

Stewart, S. J. 1991. Francisella. In: Balows, A., W. J. Hausler, Jr., K. L. Herrmann, H. D. Isenberg, and H. J. Shadomy (ed.). Manual of Clinical Microbiology. Am. Society for Microbiology, pp. 454-456. Franz, D. R., P. B. Jahrling, A. M. Friedlander, D. J. McClain, D. L. Hoover, W. R. Bryne, J. A. Pavlin, G. W. Christopher and E. M. Eitzen, Jr. 1997. Clinical recognition and management of patients exposed to biological warfare agents. JAMA, 278:399-411. Evans, M. E., and A. M. Friedlander. Tularemia. In: F. R. Sidell, E. T. Takafuji and D. R. Franz (ed.) Medical Aspects of Chemical and Biological Warfare. 1997. Published by the Office of the Surgeon General at TMM Publications. pp. 503-512. Cherwonogrodzky, J. W., M. H. Knodel, and M. R. Spence. 1994. Increased encapsulation and virulence of Francisella tularensis live vaccine strain (LVS) by subculturing on synthetic medium. Vaccine. 2:773-775. Corbel, M. J. Recent advances in the study of Brucella antigens and their serological cross-reactions. 1985. Veterinary Bulletin. 55: 927-942. Sjostedt, A. 1997. Host-parasite interactions during tularemia. (Introductory remarks to the presentation, given at the Medical Protection B Conference, Munich, Germany). Golovliov, I., M. Ericsson, L. Akerblom, G. Sandstrom, A. Tarnvik and A. Sjostedt. 1995. Adjuvanicity of ISCOMS incorporating a T-cell reactive lipoprotein of the facultative intracellular pathogen Francisella tularensis. Vaccine. 13:261-267. Hood, A. M. 1977. Virulence factors of Francisella tularensis. J. Hyg. Camb. 79: 47-60 Ancuta, P., T. Pedron, R. Girard, G. Sandstrom and R. Chaby. 1996. Inability of the Francisella tularensis lipopolysaccharide to mimic or to antagonize the induction of cell activation by endotoxins. Infect. Immun. 64: 2041-2046. Conlan, J. W., H. Shen, A. Webb, M. B. Perry. 2002. Mice vaccinated with the O-antigen of Francisella tularensis LVS lipopolysaccharide conjugated to bovine serum albumin develop varying degrees of protective immunity against systemic or aerosol challenge with virulent type A and type B strains of the pathogen. Vaccine 20: 3465-3471. Cherwonogrodzky, J. W. 1983. Factors controlling haemolysin production in Vibrio parahaemolyticus. Ph.D. thesis, University of Toronto, pages 161-162.

Tularemia is primarily a disease of wildlife that spreads to humans incidentally such as by insect or tick bites, handling infected carcasses or by drinking contaminated water. The disease usually progresses from an ulcer (at the site of infection or within the bowel if ingested) to oculoglandular infections (eyes are stressed and ‘flu’-like symptoms such as chills, fever, headache and general aches and pains becoming progressively worse) then systemic gastrointestinal or pleuropneumonia tularemia that causes severe illness with a high mortality rate (30-60%) unless antibiotic therapy is given. Although the incidence of tularemia has declined with the decline of market hunting and trapping, it is still widespread around the globe, infecting wildlife, domestic animals and humans (Stewart, 1991). The bacterium is readily grown on simple medium with a cysteine supplement, and it is highly virulent when delivered as an aerosol or in contaminated water. It is a potential threat agent for biological warfare or terrorist programs (Franz et al., 1997).

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