# US 5,352,450 A · Method for preparing vaccine for dental caries and vaccinal compositions for dental caries used as nasal drop

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- Number: US 5,352,450 A
- Document ID: US5352450A
- Status: Granted
- Kind: A
- Application number: 07/529,602
- Filed: 1990-05-29
- Granted: 1994-10-04
- Earliest claimed: 1989-05-29
- Assignees: Lion Corporation; National Institute of Health
- Inventors: Toshihiko Koga; Nobuo Okahashi; Ichiro Takahashi; Koji Shibuya; Hirotaka Ohta
- Web page: https://patentgrep.com/patent/US5352450A

## CPC

- A61K 9/0043: {Nose}
- C07K 14/315: from Streptococcus (G), e.g. Enterococci
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

A method for preparing a vaccine for dental caries comprises the step of culturing a variant which is obtained by integrating a protein antigen (PAc)-expressing gene into the chromosomal gene of a Streptococcus mutans GS-5 strain to obtain the protein antigen, the protein antigen being produced on the surface of cells of oral Streptococcus mutans or it being extracellularly produced by the microorganism and having a molecular weight ranging from about 170,000 to 220,000. Streptococcus mutans GS-5 (K-3), in which a protein antigen-expressing gene is integrated into the chromosomal gene thereof, has an ability of producing the protein antigen on the surface of the cells or extracellularly. A preventive vaccine composition for dental caries for nasal drops comprises the protein antigen thus produced by the strain: Streptcoccus mutans, the vaccine being intranasally administered. The method makes it possible to enhance the yield of PAc and to simplify processes for purifying PAc. The vaccine composition makes-it possible to internally easily absorb the protein antigen, PAc, in high efficiency and it also makes it possible to effectively increase the antibody titer observed after the administration thereof.

## Claims

### Claim 1

A method for preparing a vaccine against dental caries comprising integrating a protein antigen-expressing gene (Pac-expressing gene) into a Streptococcus mutans GS-5 strain to produce a variant bacterial strain; culturing the variant bacterial strain; the variant Streptococcus mutans GS-5 strain encoding a protein antigen to produce the protein antigen on the surface of cells of Streptococcus mutans or to extracellularly produce the protein antigen, wherein the protein antigen produced has a molecular weight ranging from about 170,000 to 220,000; and recovering the protein antigen produced by the variant bacterial strain.

### Claim 2 (depends on 1)

The method of claim 1 wherein the protein antigen has a molecular weight of about 190,000.

### Claim 3 (depends on 1)

The method of claim 1 wherein the Streptococcus mutans GS-5 strain is GERM BP-2436.

### Claim 4 (depends on 1)

The method of claim 1 wherein a Streptococcus mutans GS-5 (K-3) strain, FERM BP-2437, is cultured.