Use of GM-CSF as a vaccine adjuvant

Details Use of GM-CSF as a vaccine adjuvant Use of GM-CSF as a vaccine adjuvant

1995-01-05

1997-10-21

Budens, Robert D.

Drug, bio-affecting and body treating compositions

Nonspecific immunoeffector, per se ; or nonspecific...

4242091, 4242271, A61K 3819, A61K 39145, A61K 3929, A61K 4500

Patent

active

056793561

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

The present invention relates to the use of granulocyte-macrophage-colony stimulating factor (GM-CSF), particularly human GM-CSF, as a vaccine adjuvant.


BACKGROUND OF THE INVENTION

Active immunization is the administration of an antigen to an animal to bring about an immune response in the animal. A vaccine against a microorganism is an antigenic preparation which when inoculated into a non-immune individual will confer active immunity to the microorganism but will not cause disease. Specificity and memory, the two key elements of the adaptive immune system, are exploited in vaccination, since the adaptive immune system mounts a much stronger response on second encounter with an antigen. This secondary immune response is both faster to appear and more effective than the primary response. The principle of vaccine development is to alter a microorganism or its toxins (natural antigens) in such a way that they become innocuous without losing antigenicity. Alternatively, antigenic polypeptides of the organism in question can be produced by recombinant methods or by synthetic chemistry to produce an effective vaccine.
One problem that frequently is encountered in the course of active immunization is that the antigens used in the vaccine are not sufficiently immunogenic to raise an antibody titer to sufficient levels to provide protection against subsequent challenge, or to maintain the potential for mounting these levels over extended time periods. Another problem is that the vaccine may be deficient in inducing cell-mediated immunity which is a primary immune defense against bacterial and viral infection. Still another problem is that an individual patient might be immunosuppressed.
To obtain a stronger humoral and/or cellular response, it is common to administer a vaccine in a formulation containing an adjuvant. An adjuvant is a substance that enhances, nonspecifically, the immune response to an antigen, or which causes an individual to respond to an antigen who would otherwise without the adjuvant not respond to the antigen. An adjuvant is usually administered with an antigen, but may also be given before or after antigen administration. Suitable adjuvants for the vaccination of mammals include but are not limited to Adjuvant 65 (containing peanut oil, mannide monooleate and aluminum monostearate); Freund's complete or incomplete adjuvant; mineral gels such as aluminum hydroxide, aluminum phosphate and alum; surfactants such as hexadecylamine, octadecylamine, lysolecithin, dimethyldioctadecyl-ammonium bromide, N,N-dioctadecyl-N',N'-bis(2-hydroxymethyl) propanediamine, methoxyhexadecylglycerol and pluronic polyols; polyanions such as pyran, dextran sulfate, poly IC, polyacrylic acid and carbopol; peptides such as muramyl dipeptide, dimethylglycine and tuftsin; and oil emulsions. The antigens could also be administered following incorporation into liposomes or other microcarriers.


SUMMARY OF THE INVENTION

It has been surprisingly discovered that granulocyte-macrophage-colony stimulating factor (GM-CSF) is an effective vaccine adjuvant.
Accordingly, the present invention provides a method for enhancing the immune response of a mammal to a vaccine comprising administering to a mammal in need of vaccination an effective amount of GM-CSF in conjunction with a vaccine.
Preferably, the mammals treated will be humans and the GM-CSF utilized will be one of the human allotypes. Preferably, the GM-CSF will be administered from 1 to 14 days prior to or after the administration of the vaccine in an amount of about 0.1 to 100 micrograms (.mu.g) per kilogram of body weight.
The present invention further provides for a pharmaceutical composition comprising an effective amount of GM-CSF, a natural, synthetic or recombinant antigen, and a pharmaceutically acceptable carrier.
Also claimed is a kit for enhancing an immunogenic response of a mammal to antigens in a vaccine comprising a first container having a pharmaceutical composition of GM-CSF contained therein; and a second container having a pha

REFERENCES:
patent: 5100664 (1992-03-01), Doyle et al.
Morrissey et al., Journal of immunology, vol. 139 issue 4, pp. 1113-1119. "Granulocyte-macrophage colony-stimulating factor augments the primary antibody response by enhancing the function of antigen-presenting cells, " Aug. 15, 1987.
Schrader, 1991, Molecular Immunology 28 (3):295-299.
Patent abstracts of Japan, 1988, vol. 12 No. 30: (C485) (2950).

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