Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Amino acid sequence disclosed in whole or in part; or...
Reexamination Certificate
1999-07-20
2002-01-29
Brusca, John S. (Department: 1631)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Amino acid sequence disclosed in whole or in part; or...
C530S350000
Reexamination Certificate
active
06342223
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to the fields of microbiology and vaccine technology, and concerns the development of a vaccine capable of conferring immunity to infection by group B Streptococcus.
BACKGROUND OF THE INVENTION
Bacteria of the Streptococcus genus have been implicated as causal agents of disease in humans and animals. The Streptococci have been divided into immunological groups based upon the presence of specific carbohydrate antigens on their cell surfaces. At present, groups A through O are recognized (Davis, B. D. et al., In:
Microbiology
, 3rd. Edition, page 609, (Harper & Row, 1980). Streptococci are among the most common and important bacteria causing human disease. Although Streptococci of the B group are associated with animal disease (such as mastitis in cattle),
Streptococcus agalactiae
(a group B Streptococci) has emerged as the most common cause of human neonatal sepsis in the United States and is thought to be responsible for over 6000 deaths annually (Hill, H. R. et al.,
Sexually Transmitted Diseases
, McGraw Hill, pp. 397-407). Group B Streptococcus is also an important pathogen in late-onset meningitis in infants, in postpartum endometritis, and in infections in immunocompromised adults (Patterson, M. J. et al.,
Bact. Rev
. 40:774-792 (1976)). Although the organism is sensitive to antibiotics, the high attack rate and rapid onset of sepsis in neonates and meningitis in infants results in both high morbidity (50%) and mortality (20%) (Baker, C. J. et al.,
New Eng. J. Med
. (Editorial) 314(26):1702-1704 (1986); Baker, C. J. et al.,
J. Infect. Dis
. 136:137-152 (1977)).
Group B Streptococcus is a common component of normal human vaginal and colonic flora. While the most common route of neonatal infection is intrapartum from vaginal colonization, nosocomial spread in newborn nurseries has also been described (Patterson, M. J. et al.,
Bact. Rev
. 40:774-792 (1976)). However, only a small percentage of infants colonized with group B Streptococcus develop serious infections. The role of both host factors and bacterial virulence determinants in the transition from colonization to infection is not well understood.
Several proteins from group B Streptococcus are thought to have a role in virulence and immunity (Ferrieri, P,
Rev. Infect. Dis
. 10:S363 (1988)). In 1975, Lancefield defined the C proteins of group B Streptococcus by their ability to elicit protective immunity (Lancefield, R. C, et al.,
J. Exp. Med
. 142:165-179 (1975)). This group of proteins is thought to contain several different polypeptides and antigenic determinants. In view of these findings, efforts to prevent infections with group B Streptococcus have been directed towards the use of prophylactic antibiotics and the development of a vaccine against group B Streptococcus (Baker, C. J, et al.,
Rev. of Infec. Dis
. 7:458-467 (1985), Baker, C. J. et al.,
New Eng. J. Med
. (Editorial) 314(26):1702-1704 (1986)). Polysaccharide vaccines against group B Streptococcus are described by Kasper, D. L. (U.S. Pat. No. 4,207,414 and U.S. Reissue Pat. No. RE31672, and U.S. Pat. Nos. 4,324,887, 4,356,263, 4,367,221, 4,367,222, and 4,367,223), by Carlo, D. J. (U.S. Pat. No. 4,413,057, European Patent Publication 38,265), and by Yavordios, D. et al. (European Patent Publication 71,515), all of which references are incorporated herein by reference.
Except for the small sub-population of infants in whom both maternal colonization with group B Streptococcus and other perinatal risk factors can be identified, the use of prophylactic antibiotics has not been practical or efficacious in preventing the majority of cases (Boyer, K. M, et al.,
New Eng. J. Med
. 314(26):1665-1669 (1986)). Intrapartum chemoprophylaxis has not gained wide acceptance for the following reasons: (1) It has not been possible to identify maternal colonization by group B Streptococcus in a fast, reliable and cost-effective manner; (2) About 40% of neonatal cases occur in low-risk settings; (3) It has not been considered practical to screen and/or treat all mothers or infants who are potentially at risk; and (4) antibiotic prophylaxis has not appeared to be feasible in preventing late-onset meningitis (7200 cases per year in the United States) or postpartum endometritis (45,000 cases annually) (Baker, C. J. et al.,
New Eng. J. Med
. (Editorial) 314:1702-1704 (1986)).
DEPOSIT OF MICROORGANISMS
Plasmids pJMS1 and pJMS23 are derivatives of plasmid pUX12 which contain DNA capable of encoding antigenic Streptococd proteins that may be used in accordance with the present invention. Plasmid pUX12 is a derivative of plasmid pUC12. Plasmids pJMS1 and pJMS23 were deposited on Sep. 15, 1989, at the American Type Culture Collection, Rockville, Md. and given the designations ATCC 40659 and ATCC 40660, respectively.
SUMMARY OF THE INVENTION
Streptococcus agalactiae
is the most common cause of neonatal sepsis in the United States and is responsible for between 6,000 and 10,000 deaths per year. While the type-specific polysaceharide capsule of group B Streptococcus is immunogenic and carries important protective antigens, clinical trials of a polysaccharide vaccine have shown a poor response rate (Baker, C. J. et al.,
New Engl. J. Med
. 319:1180 (1980); Insel, R. A, et al.,
New Eng. J. Med
. (Editorial) 319(18):1219-1220 (1988)).
The present invention concerns the development of a conjugate vaccine to group B Streptococcus, (i.e.
Streptococcus agalactiae
) that utilizes to a protective protein antigen expressed from a gene cloned from group B Streptococcus. This novel conjugate vaccine has the advantages both of eliciting T cell dependent protection via the adjuvant action of the carrier protein and also providing additional protective epitopes that are present on the cloned group B Streptococcus protein (Insel, R. A, et al.,
New Eng. J. Med
. (Editorial) 319(18):1219-1220 (1988); Baker, C. J, et al.,
Rev. of Infec. Dis
. 7:458-467 (1985)).
In detail, the invention provides a conjugate vaccine capable of conferring host immunity to an infection by group B Streptococcus which comprises (a) a polysaccharide conjugated to (b) a protein; wherein both the polysaccharide and the protein are characteristic molecules of the group B Streptococcus, and wherein the protein is a derivative of the C protein alpha antigen that retains the ability to elicit protective antibodies against the group B Streptococcus.
The invention also concerns a method for preventing or attenuating an infection caused by a group B Streptococcus which comprises administering to an individual, suspected of being at risk for such an infection, an effective amount of the conjugate vaccine of the invention, such that it provides host immunity against the infection.
The invention further concerns a method for preventing or attenuating infection caused by a group B Streptococcus which comprises administering to a pregnant female an effective amount of a conjugate vaccine of the invention, such that it provides immunity to the infection to an unborn offspring of the female.
The invention also provides a method for preventing or attenuating an infection caused by a group B Streptococcus which comprises administering to an individual suspected of being at risk for such an infection an effective amount of an antisera elicited from the exposure of a second individual to a conjugate vaccine of the invention, such that is provides host immunity to the infection.
REFERENCES:
patent: 4207414 (1980-06-01), Kasper
patent: 4284537 (1981-08-01), Beachey
patent: 4324887 (1982-04-01), Kasper
patent: 4356170 (1982-10-01), Jennings et al.
patent: 4356263 (1982-10-01), Kasper
patent: 4367221 (1983-01-01), Kasper
patent: 4367222 (1983-01-01), Kasper
patent: 4367223 (1983-01-01), Kasper
patent: 4425330 (1984-01-01), Norcross et al.
patent: 4619828 (1986-10-01), Gordon
patent: 4673574 (1987-06-01), Anderson
patent: 4757134 (1988-07-01), Blake et al.
patent: 4761283 (1988-08-01), Anderson
patent: 4789735 (1988-12-01), Frank et al.
patent: 4830852 (1989-05-01), Marburg et al.
patent:
Ausubel Frederick M.
Kasper Dennis L.
Madoff Lawrence C.
Michel James L.
Brusca John S.
Strerne, Kessler, Goldstein & Fox, P.L.L.C.
The General Hospital Corporation & Brigham and Women's Hosp
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