Drug – bio-affecting and body treating compositions – Nonspecific immunoeffector – per se ; or nonspecific...
Reexamination Certificate
1998-06-01
2002-05-21
Scheiner, Laurie (Department: 1648)
Drug, bio-affecting and body treating compositions
Nonspecific immunoeffector, per se ; or nonspecific...
C424S206100, C424S240100, C514S055000
Reexamination Certificate
active
06391318
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention is generally in the field of vaccine compositions, and specifically those for intranasal administration.
Vaccines are preparations of antigenic materials, administered to recipients with a view to enhancing resistance to infection by inducing active immunity to specific microorganisms, for example bacteria or viruses.
Vaccines, which may be as single or mixed component vaccines, are presented in a variety of forms. For example, current influenza vaccines consist of either inactivated whole virus, disrupted virus (split vaccines) or purified preparations of antigenic proteins.
Vaccines are typically administered parenterally via injections. Traditional parenteral immunisation regimes are known to have a number of drawbacks. For example, many individuals possess a natural fear of injections and may experience psychological discomfort as a result. Furthermore, many individuals find injections physically uncomfortable. Moreover, parenteral vaccination (e.g. intramuscular, sub-cutaneous etc.) is not an effective means of eliciting local antibody production if there has been no previous local exposure (e.g. by way of infection).
An effective local and/or topical administration regime is therefore desirable.
In the case of some diseases, it would be advantageous to stimulate the mucosal immune system. In order to do this, the vaccine must be applied topically to a mucosal surface. Thus, in certain cases (e.g. in the case of infections of the upper respiratory tract), it would be beneficial to obtain more effective stimulation of the local mucosal immune system of the respiratory tract.
Accordingly, a number of attempts have been made to develop mucosal vaccines. One drawback, however, is that inactivated vaccines are often poorly immunogenic when given mucosally. In order to overcome this problem, different approaches to improving the immunogenicity of vaccines given orally or intranasally have included the use of adjuvants (see below), encapsulation of the vaccine in a variety of microspheres, and the use of live attenuated strains.
Certain adjuvants have been shown, when co-administered with vaccine antigens, to further boost the effectiveness of vaccine compositions by stimulating the immune response (see e.g. Hibberd et al,
Ann. Intern. Med
., 110, 955 (1989)). Examples of adjuvants which have been shown to be effective include interferon alpha,
Klebsiella pneumoniae
, glycoprotein and interleukin-2.
Chitosans are derivatives of chitin or poly-N-acetyl-D-glucosamine in which the greater proportion of the N-acetyl groups have been removed through hydrolysis.
European Patent Application 460 020 discloses pharmaceutical formulations including chitosans as mucosal absorption enhancers. That the chitosan could provide an adjuvant effect when administered in a vaccine composition is neither disclosed nor suggested.
SUMMARY OF THE INVENTION
Provided are vaccine compositions for intranasal administration, which compositions include one or more antigen and an effective adjuvant. Also provided are methods of immunizing a mammal against diseases by administering such compositions to the mammal, methods of enhancing the immunogenicity of intranasally administered antigens, and uses of antigens in combination with an adjuvant for the manufacture of a vaccine composition for intranasal administration to immunize a mammal against specific diseases.
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Aspden, T.J., et al., 1995, “Chitosan as a nasal delivery system: Evaluation of the effect of chitosan on mucociliary clearance rate in the frog palate model”, Internat. J. Pharmaceut. 122:69-78.*
Polk, A.E., et al., 1994, “Oral delivery in aquaculture: controlled release of proteins from chitosan-alginate microcapsules”, Aquacult. Engineer. 13:311-323.*
Illum, L., et al., 1994, “Chitosan as a novel nasal delivery system for peptide drugs”, Pharmaceut. Res. 11(8):1186-1189.*
Cahill, et al., “Mice are protected againstBordetella pertussisinfection by intra-nasal immunization with filamentous haemagglutinin,”FEMS Microbiology Letters107:211-16 (1993).
de Haan, et al., “Mucosal immunoadjuvant activity of liposomes: induction of systemic IgG and secretory IgA responses in mice by intranasal immunization with an influenza subunit vaccine and coadministered liposomes,”Vaccine13(2):155-62 (1995).
Hibberd, et al., “Immunization Strategies for the Immunocompromised Host: The Need for Immunoadjuvants,”Ann. Intern. Med.110:995-56 (1989).
Nishimura, et al., “Adjuvant activity of chitin derivatives in mice and guinea-pigs,”Vaccine3(5):379-84 (1985).
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Chatfield Steven Neville
Illum Lisbeth
Akin Gump Strauss Hauer & Feld L.L.P.
Parkin Jeffrey S.
Scheiner Laurie
West Pharmaceutical Services Drug Delivery & Clinical Research C
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