Immunodulatory complex and use thereof in helicobacter diseases

Details Immunodulatory complex and use thereof in helicobacter diseases Immunodulatory complex and use thereof in helicobacter diseases

1998-08-25

2004-10-19

Swartz, Rodney P (Department: 1645)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

C424S180100, C424S184100, C424S190100, C424S193100, C424S203100, C424S234100, C424S282100, C435S007320, C530S323000

Reexamination Certificate

active

06806253

ABSTRACT:

TECHNICAL FIELD OF THE INVENTION
The present invention relates to a therapeutic and preventive anti-bacterial vaccine complex which possesses a vaccinating power linked to the presence of specific antigens against
Helicobacter pylori
(previously called
Campylobacter pylori
),
Helicobacter hepaticus, Helicobacter coronari
, and nonspecific antigens providing immunomodulation.
BACKGROUND OF THE INVENTION
(MARSHALL B. J., WARREN Jr., Unidentified curved
bacilli
in the stomach of the patients with gastritis and peptic ulceration
Lancer
1984: i:1311-4)).
(MÉGRAUD F.,
Helicobacter pylori
, the most important bacterium among the mucus bacteria.
La letter de l'infectiologue
1993; 8 (suppl. 4): 151-9).
It is well known, in bacteriology, that the surface antigens of the walls, membranes or capsules (combined or free in soluble form in the culture medium) are of a glycoprotein, polypeptide or polysaccharide nature.
Vaccines combining associative factors, such as membrane proteoglycan or polysaccharide substances, extracted from pathogenic microbes, with ribonucleic acid of ribosomal origin (RNA) can be used in the production of acellular vaccines (cf. Inf. and Immunity, 1, 574-82, 1970 and PCT WO 94/22462).
These vaccines use specific antigens corresponding to specifically determined microbial diseases.
However, the antigenicity is essentially linked to the level of RNA (of the ribosomes in particular) in microbial cells, inter alia. Immunocompetent cells (ICC) directly use these RNAs as active carriers.
SUMMARY OF THE INVENTION
To produce the complex of the invention, with the
Helicobacter
bacterial serotype antigen, we coupled preferably by means of covalent bonds, RNA, preferably of ribosomal origin, with an amino acid sequence of glycoprotein nature, preferably present in type III collagen. In humans, collagen represents approximately a third of the proteins in the body. The type III was chosen for its amino acid sequence and its presence in the dermis, the vascular wall and the digestive epithelial mucous membranes.
In our complex, we have used, as stabilizer, cell membrane fractions derived from the same microbes as those which served for the production of the ribosomal RNA. These membrane fractions contain all of the peptidoglycan substances and are known, in addition, as immunity adjuvants.
It is, in addition to
Helicobacter pylori, hepaticus
and
coronari
, useful to have—glucopolysaccharide or proteoglycan—membrane fractions derived from various microbial organisms which have served to provide the RNA by extraction of their ribosomes, which microbes are known for their immunogenesis (recruitment of macrophages, activation of T lymphocytes, potentiation of the synthesis of immunoglobulins, secretory IgA's in particular (11 S), increase in phagocytosis and stimulation of dependent T cells and the like).
This was thus thought of because, in the precise case of the pathogenesis induced by
Helicobacter pylori, hepaticus
or
helmannii, coronari
, the body must produce, in addition to the specific humoral immune response, a cellular response in order to make up for the inefficacy of the antibodies in protecting the individual.
It is known that cell-mediated response does not give rise to the production of antibodies, but only to the generation of sensitized lymphoid cells specific for the antigen involved.
The T lymphocytes act by themselves and/or through the cytokines, and either an inflammatory type response or a cytotoxic response is observed.
The pathogenic power of
Helicobacter
lies in its ability to colonize the gastric mucous membrane, to survive in the gastric juice and to multiply therein in spite of the host's immune response, and to generate lesions which are sometimes irreversible (adenocarcinoma, gastric lymphoma or MALT “mucous associated lymphoid tissue” lymphomas),
(PARSONNET J:
Helicobacter pylori
and gastric cancer. Gastroenterol Clin North Am 1993, 22:89-104.
WORTHERSPOON A. C., DOGLIONI C., DISS T. C. et al.: Regression of primary low-grade B-cell gastric lymphoma of mucosa associated lymphoid tissue type after eradication of
Helicobacter pylori
. Lancet 1993; 342:575-7.
MOHANDAS,
Helicobacter pylori
and lymphoma, N Eng J Med 1994: 331:746-7).
when it is insufficient during injection: resistance to phagocytosis, induction of apoptosis and the like.
(PETERSON P. K., VERHOEF J., SCHMELING D. & QUIE P. G.: Kinetics of phagocytosis and bacterial killing by human polymorphonuclear leucocytes and monocytes, J. Infec. Dis. 136:502-509, 1977.
KIEHLBAUCH J. A., ALBACH R. A., BAUM I. K., CHANG K. P. Phagocytosis of
Campylobacter jejuni
and its intracellular survival in mononuclear phagocytes, Infect Immun 1985; 48:446-51).


REFERENCES:
patent: 4460575 (1984-07-01), d'Hinterland
Rappuoli et al Development of a vaccine against Helicobacter pylori : a short overview, European Journal of Gastroenterology and Hepatology, vol. 5, (suppl. 2) pp. 576-578, 1993.*
Yokota et al. “Low Antigenicity of the Polysaccharide Region of Helicobacter pylori” Infection and Immunity vol. 65, No. 9, pp. 3509-3512, 1997.*
HP World-Wide, a publication from Brocades Pharma BV Leiderdorp, The Netherlands, Feb. 1992.*
Buck et al. “Relation of Campylobacter pyloridis to Gastric and Peptic Ulcer”, The Journal of Infectious Diseases, vol. 153, No. 4, pp. 664-669, 1986.*
U.S. patent application Ser. No. 08/347,322, Torossian, filed Jan. 30, 1995.
Use of Bacterial Ribosomal Immunostimulators in Respiratory Tract.

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