Appeal No. 1997-3019
Application No. 08/404,122
component of a vaccine which “facilitates or enhances the immune response to an antigen
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with which it is combined.” According to the specification (pages 1 through 3):
Materials having adjuvant activity are well known. Currently, however, [a]lum .
. . and similar aluminum gels are the only adjuvants licensed for human use . .
. Other material are also known to have adjuvant activity, and these include:
Freund’s complete adjuvant, . . . Freund’s incomplete adjuvant, . . . saponin, .
. . nonionic block copolymer surfactants, . . . and muramyl dipeptide . . .
With all of these agents toxicity, and unacceptable chronic reactions,
depending on dose, are a feature which currently limit their use as potential
alternatives to alum. Alum, on the other hand, will not stimulate cell-mediated
immunity, and although having a broad spectrum of activity, is not effective in
all potential vaccines, since in peptide vaccines, adsorption onto the alum
may be poor due to the small size of the peptide. Occasionally, alum may
induce the degradation of antigens by proteases with great efficiency. Thus
it is apparent that there is a need for new adjuvants.
NAGO, a combination of neuraminidase and galactose oxidase, is known in
the art to induce T lymphocyte proliferation by the induction of aldehydes on
cell membranes.
The present inventors have now discovered that a combination of
neuraminidase and galactose oxidase (NAGO) possesses potent adjuvant
properties. NAGO has been found to be a non-reactogenic adjuvant of
unprecedented potency in the induction of T-cell responses. In particular it
was as effective or better than Freund complete adjuvant in the induction of
cytotoxic T-cells induced with peptide by recogni[z]ing cells infected with live
virus. It was also more effective than Freund complete adjuvant in priming T-
cells to the envelope glycoprotein gp120 of human immunodeficiency virus.
Strong adjuvant effects were exemplified with peptide and protein and
polysaccharide antigens of bacterial, viral and protozoal origin. Local
reactions produced by NAGO were very mild and were no different to, or
less than, those induced by alhydrogel, the only adjuvant licensed for human
use.
3 Illustrated Dictionary of Immunology, J.M. Cruse and R.E. Lewis, CRC Press, Inc.
Boca Raton, FL, 1995, page 7 (“adjuvant”) attached.
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