Title:  Helicobacter pylori proteins useful for vaccines and diagnostics

United States Patent:  6,130,059

Inventors:  Covacci; Antonello (Vc.Provenzano, 8, 53100, Siena, IT); Bugnoli; Massimo (V. del Pozzo, 38, 53035, Monteriggioni, IT); Telford; John (Via Sambuco, 43, 53010, Monteriggioni, IT); Macchia; Giovanni (Via Monte Velino 57, 67051 Avezzano (AQ), IT); Rappuoli; Rino (Via Calamandrei, 39, 53010 Quercegrossa (SI), IT)

Filed:  June 6, 1995

Helicobacter pylori is known to cause or be a cofactor in type B gastritis, peptic ulcers, and gastric tumors. In both developed and developing countries, a high percentage of people are infected with this bacterium. The present invention relates generally to certain H. pylori proteins, to the genes which express these proteins, and to the use of these proteins for diagnostic and vaccine applications. Specifically, molecular cloning, nucteotide, and amino acid sequences for the H. pylori cytotoxin (CT), the "Cytotoxin Associated Immunodominant" (CAI) antigen, and the heat shock protein (hsp60). are described herein.

SUMMARY OF THE INVENTION

The present invention describes nucleotide and amino acid sequences for three major H. pylori proteins. Specifically, these are the cytotoxin, the "Cytotoxin Associated Immunodominant" (CAI) antigen, and the heat shock protein. None of the complete amino acid sequences for these proteins has been known, nor have their genes been identified. The present invention pertains to not only these purified proteins and their genes, but also recombinant materials associated therewith, such as vectors and host cells. The understanding at the molecular level of the nature and the role of these proteins and the availability of recombinant production has important implications for the development of new diagnostics for H. pylori and for the design of vaccines that may prevent H. pylori infection and treat disease.

As such, these proteins can be used in both vaccine and diagnostic applications. The present invention includes methods for treating and diagnosing those diseases associated with H. pylori. As H. pylori has been associated with type B gastritis, peptic ulcers, and gastric adenocarcinoma, it is hoped that the present invention will assist in early detection and alleviation of these disease states. Currently, diagnosis relies mostly on endoscopy and histological staining of biopsies; existing immunoassays are based on H. pylori lysates or semi-purified antigens. Given the heterogeneity found in such assays, correlation with disease state is not yet well established. Thus, the potential for recombinant antigen-based immunoassays, as well as nucleic acid assays for disease detection, is great. At present, there is no commercial vaccine for H. pylori infection or treatment. A recombinant vaccine is thus an object of the present invention.

Claim 1 of 6 Claims

What is claimed is:

1. A recombinant polynucleotide encoding a Helicobacter pylori cytotoxin, wherein said polynucleotide consists of SEQ ID NO:2.

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