# US 5,186,933 A · Synthesis and immunogenicity of rotavirus genes using a baculovirus expression system

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- Number: US 5,186,933 A
- Document ID: US5186933A
- Status: Granted
- Kind: A
- Application number: 06/947,773
- Filed: 1986-12-30
- Granted: 1993-02-16
- Earliest claimed: 1986-12-30
- Assignees: Baylor College of Medicine
- Inventors: Mary K. Estes
- Web page: https://patentgrep.com/patent/US5186933A

## CPC

- C12N 15/86: Viral vectors
- C07K 14/005: from viruses
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- C12N 2710/14143: viral genome or elements thereof as genetic vector
- C12N 2720/12122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2720/12322: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2720/12334: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- Y10S 530/826: Viruses
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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)
- 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)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

A method to express rotavirus genes in a baculovirus system. Different clones are used to express rotavirus genes for all of the viral proteins. These proteins are isolated in their native conformation. Some of these proteins show antigenic properties and are used to vaccinate human, agricultural animals and pet animals against diarrheal disease. The antigenic proteins are also used to detect the presence of the viral infectious agent either by themselves or in conjunction with antibodies produced against the antigenic proteins.

## Claims

### Claim 1

A vaccine for rotavirus, comprising:
a rotavirus antigen synthesized from recombinant molecules comprising a baculovirus gene promoter and at least one rotavirus gene, said promoter spatially positioned in relation to said gene effective to regulate the expression of said gene, wherein said antigen is selected from the group consisting of VP1, VP2, VP3, VP4, VP7, VP9, NS35, NS34, NS28 and any combination thereof.

### Claim 2 (depends on 1)

The vaccine of claim 1, wherein
said antigen is VP7.

### Claim 3 (depends on 1)

The vaccine of claim 1, wherein
said antigen is VP3.

### Claim 4 (depends on 1)

A method of immunizing humans or animals against rotavirus gastrointestinal disease comprising the step of
orally or parenterally administering an immunological effective dose of the vaccine of claim 1.

### Claim 5 (depends on 1)

A method of prophylaxis of rotavirus infection in humans or animals which comprises the step of
orally administering a pharmacologically effective dose of the vaccine of claim 1.

### Claim 6 (depends on 1)

A method for passively immunizing human or animal infants against rotavirus infection comprising the step of actively immunizing a mother with the vaccine of claim 1 prior to her infant's birth.

### Claim 7

A vaccine for rotavirus, comprising:
a rotavirus antigen synthesized from recombinant molecules comprising a baculovirus gene promoter and at least one rotavirus gene, said promoter spatially positioned in relation to said gene effective to regulate the expression of said gene, wherein said antigen is a mixed antigen formed by co-expressed genes of recombinant molecules.

### Claim 8

A vaccine for rotavirus, comprising:
a rotavirus antigen synthesized from recombinant molecules comprising a baculovirus gene promoter and at least one rotavirus gene, said promoter spatially positioned in relation to said gene effective to regulate the expression of said gene, wherein said antigen is a mixed antigen formed by separately synthesizing an antigen selected from the group consisting of VP1, VP2, VP3, VP4, VP6, VP7, VP9, NS35, NS34, NS28 and any combination thereof, and subsequently mixing the synthesizing antigens in vitro.
