Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Patent
1996-07-29
1999-03-16
Wax, Robert A.
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
4352523, 435477, 435480, 435909, 536 231, 536 237, 424 932, 4242001, 4242351, A61K 39106, C12N 120
Patent
active
058826530
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
Vibrio cholerae (V. cholerae) is a non-invasive enteropathogen of the small bowel that does not penetrate the mucosal surface. Local Siga mediated immunity at the mucosal surface is therefore implicated as a protective mechanism. Pathogenic V. cholerae 01 elaborate a protein enterotoxin (also know as cholera enterotoxin, or choleragen, or cholera toxin) which is responsible for induction of copious secretion by the intestine resulting in watery diarrhea, the clinical consequence of cholera infection. The genes responsible for cholera enterotoxin are the ctx genes (also known as the tox genes). Cholera diarrhea can be extraordinarily severe and result in loss of so much body water and salts that dehydration, acidosis, shock, and death ensue without prompt therapy. There is known in the region of the V. cholerae chromosome containing the ctx genes that multiples copies of a 2700 base pair sequence called RS1 (for repetitive sequence) can be found. Mekalanos, Cell 35, 253-263 (1983).
Applicants have also discovered that a second enterotoxin is produced by V. cholerae which has been named zonula occludens toxin, reported in Fasano et al, Vibrio cholerae Produces a Second enterotoxin Which Affects Intestinal Tight Junctions, Proc. Nat. Acad. Sci. (USA) 88, 5242-5246 (1991).
The cholera vaccines that have been developed can be broadly divided into two categories; those aiming to stimulate antitoxic immunity and those intending to induce antibacterial immunity. Experiments with animal models support a protective role for either or both antitoxic and antibacterial immunity. It has been suggested that when both types of immunity work in Dis. 136 Suppl., S105-S1122 (1977); Peterson, J. W. Infect. Immun. 26, 594 (1979); Resnick, I. G. et al. Infect. Immun. 13, 375 (1980); Svennerholm, A.-M. et al. Infect. Immun. 13, 735 (1976)!. However, it appears that protective immunity in humans can be conferred without such synergistic effect, that is by either antitoxic immunity or antibacterial immunity Infect. Dis. 125, 647 (1972); Holmgren, J., J. Infect. Dis., supra; Lange, S. et al. Acta Path. Microbiol. Scand Sect. C 86, 145 (1978); Peterson, J. W., supra (1979); Pierce, N. F. et al. Infect Immun. 37, 687 (1982); Pierce, N. F. et al. Infect. Immun. 21, 185 (1978); Pierce, N. F. et al. J. Infect. Dis. 135, 888 (1977); Resnick, I. G. et al., supra; Svennerholm, A.-M. et al, supra!.
KILLED WHOLE CELL VACCINES
For almost a century, killed whole V. cholerae have been employed as parenteral vaccines; these vaccines are still commercially available. Experience with the parenteral whole cell vaccines has been reviewed in Joo, I. "Cholera Vaccines." In Cholera. (Barua D. and Burrows W., eds.), Saunders, Philadelphia, pp. 333-355 (1974) and in Feeley, J. D. et al. In Cholera and Related Diarrheas. 43rd Nobel Symp., Stockholm 1978. (O. Oucherlong, J. Holmgren, eds.) Karger, Basel, pp. 204-210 (1980). Such vaccines stimulate high titers of serum vibriocidal antibodies. They also stimulate increases in intestinal Siga antibody to V. cholerae somatic 0 al. Infect. Immun. 30., 427 (1980); Svennerholm, A.-M. et al. Scan. J. Immun. 6, 1345 (1977)!. It has been suggested that the Pakistani vaccine recipients respond in this way because they are already immunologically primed from prior antigenic contact, while persons living in a non-endemic area (e.g., Sweden) are not. In field trials parenteral killed whole cell vaccines have been shown to confer significant protection against the homologous V. cholerae serotype, but usually for a period of less than one (1980); Svennerholm, A.-M. et al. supra, (1977); Mosley, W. H. et al. Bull. Wld. Hlth. Org. 49, 13 (1973); Philippines Cholera Committee, Bull. Wld. Hlth. Org. 49, 381 (1973)!. There is some evidence to suggest that parenteral whole cell Inaba vaccine provides good, short term protection against Ogawa, as well as against Inaba cholera, while Ogawa vaccine is effective only against Ogawa.
By use of adjuvants, it has been possible to maintain a vaccine effic
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Levine, M. et al., "Volunteer Studies In Development of Vac
Kaper James B.
Levine Myron M.
Nashed Nashaat T.
The University of Maryland System
Wax Robert A.
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