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
2000-12-04
2004-03-23
Duffy, Patricia A. (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Amino acid sequence disclosed in whole or in part; or...
C424S192100, C424S250100, C530S326000, C530S350000
Reexamination Certificate
active
06709657
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to polynucleotides, (herein referred to as “BASB013 polynucleotide(s)”), polypeptides encoded by them (referred to herein as “BASB013” or “BASB013 polypeptide(s)”), recombinant materials and methods for their production. In another aspect, the invention relates to methods for using such polypeptides and polynucleotides, including vaccines against bacterial infections. In a further aspect, the invention relates to diagnostic assays for detecting infection of certain pathogens.
BACKGROUND OF THE INVENTION
Neisseria meningitidis
(meningococcus) is a Gram negative bacterium frequently isolated from the human upper respiratory tract. It occasionally causes invasive bacterial diseases such as bacteremia and meningitis. The incidence of meningococcal disease shows geographical seasonal and annual differences (Schwartz, B., Moore, P. S., Broome, C. V.; Clin. Microbiol. Rev. 2 (Supplement), S1 8-S24, 1989). Most disease in temperate countries is due to strains of serogroup B and varies in incidence from 1-10/100,000/year total population sometimes reaching higher values (Kaczrnarski, E. B. (1997), Commun. Dis. Rep. Rev. 7: R55-9, 1995; Scholten, R. J. P. M., Bijlmer, H. A., Poolman, J. T. et al. Clin. Infect. Dis. 16: 237-246, 1993; Cruz, C., Pavez, G., Aguilar, E., et al. Epidemiol. Infect. 105: 119-126, 1990).
Epidemics dominated by serogroup A meningococci, mostly in central Africa, are encountered, sometimes reaching levels up to 1000/100.000/year (Schwartz, B., Moore, P. S., Broome, C. V. Clin. Microbiol. Rev. 2 (Supplement), S18-S24, 1989). Nearly all cases as a whole of meningococcal disease are caused by serogroup A, B, C, W-135 and Y meningococci and a tetravalent A, C, W-135, Y polysaccharide vaccine is available (Armand, J., Arminjon, F., Mynard, M. C., Lafaix, C., J. Biol. Stand. 10: 335-339, 1982).
The polysaccharide vaccines are currently being improved by way of chemical conjugating them to carrier proteins (Lieberman, J. M. Chiu. S. S. Wong, V. K., et al. JAMA 275: 1499-1503, 1996).
A serogroup B vaccine is not available, since the B capsular polysaccharide was found to be nonimmunogenic, most likely because it shares structural similarity to host components (Wyle, F. A., Artenstein, M. S., Brandt, M. L. et al. J. Infect. Dis. 126: 514-522, 1972; Finne. J. M. Leinonen, M., Mdkela, P. M. Lancet ii.: 355-357, 1983).
For many years efforts have been initiated and carried out to develop meningococcal outer membrane based vaccines (de Moraes, J. C., Perkins. B., Camargo, M. C. et al. Lancet 340: 1074-1078, 1992; Bjune, G., Hoiby, E. A. Gronnesby. J. K. et al. 338: 1093-1096, 1991). Such vaccines have demonstrated efficcacies from 57%-85% in older children (>4 years) and adolescents.
Many bacterial outer membrane components are present in these vaccines, such as PorA. PorB, Rmp, Opc, Opa, FrpB and the contribution of these components to the observed protection still needs futher definition. Other bacterial outer membrane components have been defined by using animal or human antibodies to be potentially relevant to the induction of protective immunity, such as TbpB and NspA (Martin, D., Cadieux, N. Hamel, J. Brodeux. B.R., J. Exp. Med. 185: 1173-1183, 1997; Lissolo, L., Maitre-Wilmotte, C., Dumas, p. et al., Inf. Immun. 63: 884-890, 1995). The mechanisms of protective immunity will involve antibody mediated bactericidal activity and opsonophagocytosis.
A bacteremia animal model has been used to combine all antibody mediated mechanisms (Saukkonen, K., Leinonen. M., Abdillahi, H. Poolman, J. T. Vaccine 7: 325-328, 1989). It is generally accepted that the late complement component mediated bactericidal mechanism is crucial for immunity against meningococcal disease (Ross, S. C., Rosenthal P. J., Berberic, H. M., Densen, P. J. Infect. Dis. 155: 1266-1275, 1987).
The frequency of
Neisseria meningitidis
infections has risen dramatically in the past few decades. This has been attributed to the emergence of multiply antibiotic resistant strains and an increasing population of people with weakened immune systems. It is no longer uncommon to isolate
Neisseria meningitidis
strains that are resistant to some or all of the standard antibiotics. This phenomenon has created an unmet medical need and demand for new anti-microbial agents, vaccines, drug screening methods, and diagnostic tests for this organism.
SUMMARY OF THE INVENTION
The present invention relates to BASB013, in particular BASB013 polypeptides and BASB013 polynucleotides, recombinant materials and methods for their production. In another aspect, the invention relates to methods for using such polypeptides and polynucleotides, including prevention and treatment of microbial diseases, amongst others. In a further aspect, the invention relates to diagnostic assays for detecting diseases associated with microbial infections and conditions associated with such infections, such as assays for detecting expression or activity of BASB013 polynucleotides or polypeptides.
Various changes and modifications within the spirit and scope of the disclosed invention will become readily apparent to those skilled in the art from reading the following descriptions and from reading the other parts of the present disclosure.
REFERENCES:
patent: 2002/0018782 (2002-02-01), Jackson et al.
patent: 0 301 902 (1989-02-01), None
patent: WO98/ 02547 (1998-01-01), None
Martinez-Salazar, J. of Bacteriology, 178(7): 1800-1808, 1996.*
Sambrook et al, Molecular Cloning, A Laboratory Manual, 2ndEd., Cold Spring Harbor pp. 17.1-17.44, 1989.*
Plotkin, S.A et al (eds) “Vaccines”, W.B. Saunders, Phildelphia Chapter 29, p. 571, second full paragraph, 1988.*
Campbell, A.M., Monoclonal Antibody Technology, 1984 Elsevier Science Publishers B.V. pp. 1-32, 1984.*
Herbert et al, The Dictionary of Immunology, Academic Press, 1995.*
Feng et al., Infection and Immunity, 64(1): 363-365, 1996.*
Loosemore, et al., “TheHaemophilus influenzaeHtrA Protein Is a Protective Antigen”, Infection and Immunity, Mar. 1998, pp. 899-906.
Duffy Patricia A.
Meade Eric A.
SmithKline Beecham Biologicals (s.a.)
Sutton Jeffrey A.
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