Norovirus vaccine formulations

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Virus or component thereof

Reexamination Certificate

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C424S093100

Reexamination Certificate

active

07955603

ABSTRACT:
The present invention relates to antigenic and vaccine compositions comprising Norovirus antigens and adjuvants, in particular, mixtures of monovalent VLPs and mixtures of multivalent VLPs, and to a process for the production of both monovalent and multivalent VLPs, the VLPs comprising capsid proteins from one or more Norovirus genogroups.

REFERENCES:
patent: 5645051 (1997-07-01), Schultz et al.
patent: 5861241 (1999-01-01), Herrmann et al.
patent: 6391318 (2002-05-01), Illum et al.
patent: 6491919 (2002-12-01), Crane
patent: 6572862 (2003-06-01), Estes et al.
patent: 6602697 (2003-08-01), Cook, III
patent: 6942865 (2005-09-01), Estes et al.
patent: 7481997 (2009-01-01), Hardy
patent: 7527801 (2009-05-01), Coit et al.
patent: 2004/0063188 (2004-04-01), Robinson et al.
patent: 2004/0265377 (2004-12-01), Seager
patent: 2005/0154053 (2005-07-01), Rhijn et al.
patent: 2005/0155113 (2005-07-01), Hamilton et al.
patent: 2005/0215501 (2005-09-01), Lipford et al.
patent: 2005/0260225 (2005-11-01), Goldberg et al.
patent: 2007/0207526 (2007-09-01), Coit et al.
patent: 1186890 (2002-03-01), None
patent: WO 92/16543 (1992-10-01), None
patent: WO 2006/136566 (2006-12-01), None
patent: WO 2007/081447 (2007-07-01), None
patent: WO 2009/039229 (2009-03-01), None
Pelosi et al. J. Medical Virology, 1999, vol. 58, pp. 93-99.
Ball et al., Oral Immunization with Recombinant Norwalk Virus-Like Particles Induces a Systemic and Mucosal Immune Response in Mice.Journal of Virology1998; vol. 72(2): 1345-1353.
Estes et al., Norwalk Virus Vaccines: Challenges and Progress.Journal of Infectious Disease2000; vol. 181(Suppl 2): S367-373.
Guerrero et al., Recombinant Norwalk Virus-Like Particles Administered Intranasally to Mice Induce Systemic and Mucosal (Fecal and Vaginal) Immune Responses.Journal of Virology2001; vol. 75:9713-9722.
Hansman et al., Genetic and antigenic diversity among Noroviruses.Journal of General Virology2006; vol. 87: 909-919.
Hutson et al., Norovirus disease: changing epidemiology and host susceptibility factors.TRENDS in Microbiology2004; vol. 12(6):279-287.
Johnson et al., Multiple Challenge Study of Host Susceptibility to Norwalk Gastroenteritis in U.S. Adults.The Journal of Infectious Disease1990; vol. 161: 18-21.
Lindesmith et al., Human susceptibility and resistance to Norwalk infection.Nature Medicine2003; vol. 9(5): 548-553.
Lindesmith et al., Cellular and humoral immunity following Snow Mountain virus challenge.Journal of Virology2005; vol. 79(5): 2900-2909.
Lobue et al., Multivalent Norovirus vaccines induce strong mucosal and systemic blocking antibodies against multiple strains.Vaccine2006; vol. 24(24): 5220-5234.
Matsui et al., Immunity to Calicivirus infection.The Journal of Infectious Diseases2000; vol. 181(S2): S331-335.
Mead et al., Food Related Illness and Death in the U.S.Emerging Infectious Diseases1999; vol. 5(5): 607-635.
Nicollier-Jamot et al., Recombinant Virus-like Particles of a Norovirus (Genogroup II Strain) Administered Intranasally and Orally with Mucosal Adjuvants LT and LT(R192G) in BALB/c Mice Induce Specific Humoral and Cellular Th1/Th2-like Immune Responses.Vaccine2004; vol. 22:1079-1086.
Periwal et al., A Modified Cholera Holotoxin CT-E29H Enhances Systemic and Mucosal Immune Responses to Recombinant Norwalk Virus-like Particle Vaccine.Vaccine2003; vol. 21:376-385.
Tacket et al., Humoral, mucosal, and cellular immune response to oral Norwalk virus-like particles in volunteers.Clinical Immunology2003; vol. 108: 241-247.
Ball et al., Recombinant Norwalk virus-like particles given orally to volunteers: phase I study.Gastroenterology1999; vol. 117:40-48.
Parrino et al., Clinical immunity in acute gastroenteritis caused by Norwalk agent.New England Journal of Medicine1977; vol. 297:86-89.
Wyatt et al., Comparison of three agents of acute infectious nonbacterial gastroenteritis by cross-challenge in volunteers.Journal of Infecious. Diseases1974.; vol. 129:709-714.
Baldridge et al., Monophosphoryl lipid A enhances mucosal and systemic immunity to vaccine antigens following intranasal administration.Vaccine2000; vol. 18:2416-2425.
Baldrick et al., Safety evaluation of monophosphoryl lipid A (MPL): an immunostimulatory adjuvant.Regulatory Toxicology and Pharmacology2002; vol. 35:398-413.
Illum et al., Chitosan as a novel nasal delivery system for peptide drugs.Pharmaceutical Research1994.; vol. 11:1186-1189.
Gray et al., Detection of immunoglobulin M (IgM), IgA, and IgG Norwalk virus-specific antibodies by indirect enzyme-linked immunosorbent assay with baculovirus-expressed Norwalk virus capsid antigen in adult volunteers challenged with Norwalk virus.Journal of Clinical Microbiology1994; vol. 32:3059-3063.
Noel et al., Correlation of patient immune responses with genetically characterized small round-structured viruses involved in outbreaks of nonbacterial acute gastroenteritis in the United States, 1990 to 1995.Journal of Medical Virology1997; vol. 53:372-383.
Illum et al., Chitosan as a novel nasal delivery system for vaccines.Advanced Drug Delivery Reviews2001; vol. 51:81-96.
Davis and Illum, Absorption enhancers for nasal drug delivery.Clinical Pharmacokinetics2003; vol. 42:1107-1128.
Illum et al., Nasal drug delivery—possibilities, problems and solutions.Journal of Controlled Release2003; vol. 87:187-198.
Han et al., Immune responses to bovine norovirus-like particles with various adjuvants and analysis of protection in gnotobiotic calves.Vaccine2006; vol. 24:317-326.
Childers et al., “Adjuvant activity of monophosphoryl lipid A for nasal and oral immunization with soluble or liposome-associated antigen,” Infection and Immunity, vol. 68: 5509-5516, 2000.
Carpenter et al., Rational design of stable lyophilized protein formulations: some practical advice, Pharmaceutical Research, vol. 14: 969-975, 1997.
Malcolmson and Embleton, “Dry powder formulations for pulmonary delivery,” Pharmaceutical Science and Technology Today, vol. 1:394-398, 1998.
Angioni, C.F., “Supplementary European Search Report,” 9 pages, from European Patent Appl. No. 07853688.5, European Patent Office, The Hague, Netherlands (mailed Sep. 22, 2010).
Baric et al., “Expression and Self-Assembly of Norwalk Virus Capsid Protein from Venezuelan Equine Encephalitis Virus Replicons,” J. Virol. 76(6):3023-3030 (2002).
Bertolotti-Ciarlet et al., “Structural Requirements for the Assembly of Norwalk Virus-Like Particles,” J. Virol. 76(8):4044-4055 (2002).
Cao et al., “Structural Basis for the Recognition of Blood Group Trisaccharides by Norovirus,” J. Virol. 81(11):5949-5957 (2007).
Chen et al., “X-ray structure of a native calicivirus: Structural insights into antigenic diversity and host specificity,” Proc. Natl Acad. Sci. USA 103(21):8048-8053 (2006).
Fankhauser et al., “Molecular Epidemiology of “Norwalk-like viruses” in Outbreaks of Gastroenteritis in the United States,” J. Infect. Dis. 178(6):1571-1578 (1998).
Harrington et al., “Systemic, Mucosal, and Heterotypic Immune Induction in Mice Inoculated with Venezuelan Equine Encephalitis Replicons Expressing Norwalk Virus-Like Particles,” J. Virol. 76(2):730-742 (2002).
Herbst-Kralovetz et al., “Norwalk virus-like particles as vaccines,” Exp. Rev. Vaccines 9(3):299-307 (2010).
Huang et al., “Noroviruses Bind to Human ABO, Lewis, and Secretor Histo-Blood Group Antigens: Identification of 4 Distinct Strain-Specific Patterns,” J. Infect. Dis. 188(1):19-31 (2003).
Hutson et al., “Norwalk Virus-Like Particle Hemagglutination by Binding to H Histo-Blood Group Antigens,” J. Virol. 77(1):405-415 (2003).
Jiang et al., “Expression, Self-Assembly, and Antigenicity of the Norwalk Virus Capsid Protein,” J. Virol. 66(11):6527-6532 (1992).
Mason et al., “Expression of Norwalk virus capsid protein in transgenic tobacco and potato and its oral immunogenicity in mice,” Proc. Natl Acad. Sci. USA 93(11):5335-5340 (1996).
Richardson et al., “

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