Method of producing meningococcal meningitis vaccine for...

Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Preparing compound containing saccharide radical

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C435S084000, C435S101000, C435S252100, C435S253600, C424S250100

Reexamination Certificate

active

07491517

ABSTRACT:
Methods for producing quadrivalent meningococcal meningitis polysaccharide and conjugate vaccines for serotypes A, C, Y and W-135 disclosed.Neisseria meningitidisfastidious medium was designed to maximize the yield of capsular polysaccharides and generate minimal cellular biomass and endotoxin in a short duration of fermentation. The crude polysaccharides are isolated, purified, and mechanically depolymerized by sonication. These purified polysaccharides were found in human clinical trials to be safe and immunogenic against meningococcal disease caused byN. meningitidisA, C, Y and W-135 serogroups in sub-Saharan Africa. In the preferred embodiment, the polysaccharides are conjugated to carrier proteins of diphtheria or tetanus toxiod to an average molecular size of 5100 to 9900 Daltons and provide broad spectrum protection to humans of all ages. Accelerated polysaccharide production and the efficacy of the resulting vaccine are demonstrated.

REFERENCES:
patent: 2844515 (1958-07-01), Sobotka et al.
patent: 4123520 (1978-10-01), Hagopian et al.
patent: 4182751 (1980-01-01), Ayme
patent: 5494808 (1996-02-01), Fu
patent: 6642017 (2003-11-01), Weiser
patent: 6933137 (2005-08-01), Egen et al.
patent: 2005/0002957 (2005-01-01), Bordner
patent: 2006/0088554 (2006-04-01), Ryall
patent: WO03007985 (2003-01-01), None
patent: WO2005004909 (2005-01-01), None
Atlas et al in Handbook of Microbiological Media 2nd edition, 1997, p. 1, p. 4-7.
Clementi et al. Enzyme and Microbial Technology 17: 983-988, 1995.
Duta et al. Electron. J. Biotechnol. V. 9 No. 4 Jul. 2006.
Maccio et al Soil Biology and Biochemistry, Feb. 2002, vol. 34, No. 2, p. 201-208.
Goebel et al J. Exp. Med. May 1, 1956;103(5):577-88, see p. 577, second paragraph.
Ajello et al (Journal of Clinical Microbiology, Jul. 1984, p. 55-58.
Jennings 1990. Microbial. Immunol. 150, 97-127.
Artenstein, M. S., et al., (1970) New Engl. J. Med. 282, pp. 417-420.
Peltola, H., et al., (1997) New Engl. J. Med 297, pp. 686-691.
Reingold, A. L., et al., (1985) Lancet 2, pp. 114-118.
Brandt, B. L. and Artenstein, M. S. (1975) J. Infect. Diseases. 131, pp. S69-S72.
Kyhty, H., et al., (1980) J. Infect. Diseases. 142, pp. 861-868.
Cessey, S. J., et al., (1993) J. Infect. Diseases. 167, pp. 1212-1216.
Nahm, M. H., M. A. Apicella, and D. E. Briles. 1999. Immunity to extracellular bacteria, p. 1373-1386. In W. E. Paul (ed.), Fundamental immunology, 4th ed. Lippincott-Raven Publishers, Philadelphia, PA.
Mond, J. J., A. Lees, and C. M. Snapper. 1995. T cell-independent antigens type 2. Annu. Rev. Immunol. 13:655-692.
Dick, W. E., Jr., and M. Beurret. 1989. Glycoconjugates of bacterial carbohydrate antigens. A survey and consideration of design and preparation factors. Contrib. Microbiol. Immunol. 10:48-114.
Robbins, J. B., R. Schneerson, P. Anderson, and D. H. Smith. 1996. The 1996 Albert Lasker Medical Research Awards. Prevention of systemic infections, especially meningitis, caused byHaemophilus influenzaetype b. Impact on public health and implications for other polysaccharide-based vaccines. JAMA 276:1181-1185.
Fu et al., 1995 Biotechnology., vol. 13, pp. 170-174.
Romero, D and Outschoorn I.M. (1994) Clin. Microb. Rev. 7: 559-575.
Frantz, I.D. Jr. Growth Requirements of the Meningococcus. J. Bact., 43: 757-761, 1942.
Catlin, B.W. Nutritional profiles ofNeisseria lactamica, gonorrhoeaeandmeningitidis, in chemically defined media. J. Inf. Dis., 128(2): 178-194, 1973.
Watson RG, et al. The specific hapten of group C (group IIa) meningococcus, II. Chemical nature. J Immunol 1958; 81:337-44.
Marcelo Fossa Da Paz; Julia Baruque-Ramos; Harolda Hiss; Marcio Alberto Vicentin; Maria Betania Batista Leal; Isaias Raw. Polysaccharide production in batch process ofNeisseria meningitidisserogroup C comparing Frantz, modified Frantz and Catlin 6 cultivation media, Braz. J. Microbiol. vol. 34., No. 1. São Paulo Jan./Apr. 2003.
Cox et.al., (Andrew D Cox, J Claire Wright , Jianjun Li, Derek W Hood , E Richard Moxon, James C Richardes 2003. Phosphorylation of the lipid A region of meningococcal lipopolysaccharide: identification of a family of transferases that add phosphoethanolamine to lipopolysaccharide J Bacteriol. Jun. 2003 ;185 (11):3270-7 12754224.
Gotschlich E.C.; Liu, T.Y.; Artenstein, M.D. Human immunity to the meningococcal—III. preparation and immunochemical properties of the group A, group B, and group C meningococcal polysaccharides. J. Exp. Med., 129 (2): 1349-1365, 1969.
Carty, C.E. et al. Cultivation studies ofNeisseria meningitidisserogroups A, C, W-135 and Y. Developments in Industrial Microbiology (edited by Merck Laboratories), 25:695-700, 1984.
P Van Der Ley, J E Heckels, M Virji, P Hoogerhout, and J T Poolman Infect Immun. Sep. 1991; 59 (9): 2963-2971.
Aldert Bart et. al., Infection and Immunity, 1999, vol. 67 (8) p. 3842-3846.
Costantino, P., F. Norelli, A. Giannozzi, S. D'Ascenzi, A. Bartoloni, S. Kaur, D. Tang, R. Seid, S. Viti, R. Paffetti, M. Bigio, C. Pennatini, G. Averani, V. Guarnieri, E. Gallo, N. Ravenscroft, C. Lazzeroni, R. Rappuoli, and C. Ceccarini. 1999. Size fractionation of bacterial capsular polysaccharides for their use in conjugate vaccines. Vaccine 17:1251-1263.
Costantino, P., S. Viti, A. Podda, M. A. Velmonte, L. Nencioni, and R. Rappuoli, 1992. Development and phase 1 clinical testing of a conjugate vaccine against meningococcus A and C. Vaccine 10:691-698.
Ravenscroft, N., G. Averani, A. Bartoloni, S. Berti, M. Bigio, V. Carinci, P. Costantino, S. D'Ascenzi, A. Giannozzi, F. Norelli, C. Pennatini, D. Proietti, C. Ceccarini, and P. Cescutti. 1999. Size determination of bacterial capsular oligosaccharides used to prepare conjugate vaccines. Vaccine 17:2802-2816.
Jennings, H.J., and Lugowski, C. 1981. Immunochemistry of group A,B, and C meningococcal polysaccharide-tetanus toxoid conjugates. J. Immunol. 127, 1011-1018.
Svennerholm, L. 1957. Quantitative estimation of sialic acids. II. A colorimetric resorcinol-hydrochloric acid method. Biochim. Biophys. Acta 24:604-611.
Ricci, S., A. Bardotti, S. D'Ascenzi, and N. Ravenscroft. 2001. Development of a new method for the quantitative analysis of the extracellular polysaccharide ofNeisseria meningitidisserogroup A by use of high-performance anion-exchange chromatography with pulsed-amperometric detection. Vaccine 19:1989-1997.
Giannini, G., R. Rappuoli, and G. Ratti. 1984. The amino-acid sequence of two non-toxic mutants of diphtheria toxin: CRM45 and CRM197. Nucleic Acids Res. 12:4063-4069.
Reddy Jr, Kwang J, Varthakavi V,Lechtenberg KF, Minocha HC. Semiliki forest virus vector carrying the bovine viral diarrhea virus NS3 (p80) cDNA induced immune responses in mice and expressed BVDV protein in mammalian cells. Comp. Immunol. Microbiol. Infect. Dis. Oct. 1999; 22(4):231-46.
Granoff, D. M., and S. L. Harris. 2004. Protective activity of group C anticapsular antibodies elicited in two-year-olds by an investigational quadrivalentNeisseria meningitidis-diphtheria toxoid conjugate vaccine. Pediatr. Infect. Dis. J. 23:490-497.

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Method of producing meningococcal meningitis vaccine for... does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Method of producing meningococcal meningitis vaccine for..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method of producing meningococcal meningitis vaccine for... will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-4064600

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.