# US 7,238,481 B2 · Recombinant parainfluenza virus expression systems and vaccines

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- Number: US 7,238,481 B2
- Document ID: US7238481B2
- Status: Granted
- Kind: B2
- Application number: 10/825,355
- Filed: 2004-04-14
- Published: 2004-10-21
- Granted: 2007-07-03
- Earliest claimed: 2000-03-21
- Assignees: MedImmune Vaccines, Inc.
- Inventors: Aurelia Haller; Kathleen L. Coelingh
- Web page: https://patentgrep.com/patent/US7238481B2

## CPC

- C12N 15/86: Viral vectors
- A61K 39/12: Viral antigens
- A61K 39/155: Paramyxoviridae, e.g. parainfluenza virus
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/14: for RNA viruses
- A61P 31/16: for influenza or rhinoviruses
- A61P 37/04: Immunostimulants
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/5256: {expressing foreign proteins}
- A61K 2039/53: {DNA (RNA) vaccination}
- C12N 2760/18621: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2760/18634: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/18643: viral genome or elements thereof as genetic vector
- C12N 2760/18661: Methods of inactivation or attenuation
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to recombinant bovine parainfluenza virus (bPIV) cDNA or RNA which may be used to express heterologous gene products in appropriate host cell systems and/or to rescue negative strand RNA recombinant viruses that express, package, and/or present the heterologous gene product. The chimeric viruses and expression products may advantageously be used in vaccine formulations including vaccines against a broad range of pathogens and antigens.

## Claims

### Claim 1

A method of administration of a recombinant parainfluenza virus to a subject comprising:
administering to the subject a recombinant parainfluenza virus, said virus comprising:
(i) nucleotide sequences of a Kansas-strain bovine parainfluenza virus type 3 genome; and
(ii) one or more heterologous sequences, wherein said one or more heterologous sequences have been added to said virus genome or have been substituted for nucleotide sequences of said virus genome, wherein said heterologous sequence is added at a nucleotide position of Kansas-strain bovine parainfluenza virus type 3 selected from the group consisting of nucleotide position 5041, the HN gene, and nucleotide position 8529.

### Claim 2 (depends on 1)

The method of claim 1 wherein the heterologous sequence is derived from RSV, PIV, New Castle Disease virus, Sendai virus, Infectious Laryngotracheitis virus or influenza.

### Claim 3

A method of administration of a recombinant parainfluenza virus to a subject comprising:
administering to the subject a recombinant parainfluenza virus, said virus comprising:
(i) nucleotide sequences of Kansas-strain bovine parainfluenza virus type 3 genome comprising nucleotides 1–5041 and nucleotides 8529–15,456 of the genome of Kansas strain bovine parainfluenza virus type 3; and
(ii) F and FIN gene sequences of human parainfluenza virus type 3.

### Claim 4

A method of administration of a recombinant parainfluenza virus to a subject comprising:
administering to the subject a recombinant parainfluenza virus, said virus comprising:
(i) nucleotide sequences of Kansas-strain bovine parainfluenza virus type 3 genome; and
(ii) the F and UN gene sequences of human parainfluenza virus type 3, wherein (i) PCR amplification of nucleotide 5,255 to 6,255 of the chimeric parainfluenza virus results in a DNA fragment that is recognized by restriction endonucleases Sac I and Bgl II; and (ii) PCR amplification of nucleotide 9,075 to 10,469 of the chimeric parainfluenza virus results in a DNA fragment that is recognized by restriction endonucleases Pvu II and Bam HI.

### Claim 5

A method of administration of a recombinant parainfluenza virus to a subject comprising:
administering to the subject a recombinant parainfluenza virus, said virus comprising:
(i) nucleotide sequences of Kansas-strain bovine parainfluenza virus type 3 genome comprising nucleotides 1–5041 and nucleotides 8529–15,456 of the genome of Kansas strain bovine parainfluenza virus type 3; and
(ii) one or more sequences derived from RSV, PIV, New Castle Disease virus, Sendai virus, Infectious Laryngotracheitis virus or influenza.

### Claim 6

A method of administration of a recombinant parainfluenza virus to a subject comprising:
administering to the subject a recombinant parainfluenza virus, said virus comprising:
(i) nucleotide sequences of Kansas-strain bovine parainfluenza virus type 3 genome comprising nucleotides 1–5041 of the genome of Kansas-strain bovine parainfluenza virus type 3; and
(ii) one or more sequences derived from RSV, PIV, New Castle Disease virus, Sendai virus, Infectious Laryngotracheitis virus or influenza.

### Claim 7

A method of administration of a recombinant parainfluenza virus to a subject comprising:
administering to the subject a recombinant parainfluenza virus, said virus comprising:
(i) nucleotide sequences of Kansas-strain bovine parainfluenza virus type 3 genome; and
(ii) one or more sequences derived from RSV, PIV, New Castle Disease virus, Sendai virus, Infectious Laryngotracheitis virus or influenza, and wherein said sequences have been added at a nucleotide position of Kansas-strain bovine parainfluenza virus type 3 selected from the group consisting of nucleotide position 5041, the HN gene, and nucleotide position 8529.

### Claim 8

A method of administration of a recombinant parainfluenza virus to a subject comprising:
administering to the subject a recombinant parainfluenza virus, said virus comprising:
(i) nucleotide sequences of Kansas-strain bovine parainfluenza virus type 3 genome comprising nucleotides 8,529–15,456 of the genome of Kansas-strain bovine parainfluenza virus type 3; and
(ii) one or more sequences derived from RSV, PIV, New Castle Disease virus, Sendai virus, Infectious Laryngotracheitis virus or influenza.

### Claim 9 (depends on 2, 5, 6, 7, 8)

The method of claim 2, 5, 6, 7 or 8, wherein the one or more sequences are derived from RSV, PIV, or influenza.

### Claim 10 (depends on 2, 5, 6, 7, 8)

The method of claim 2, 5, 6, 7 or 8, wherein the one or more sequences are derived from human RSV, human PIV, or human influenza.

### Claim 11 (depends on 2, 5, 6, 7, 8)

The method of claim 2, 5, 6, 7 or 8, wherein the one or more sequences are derived from both human RSV and human PIV.

### Claim 12 (depends on 5, 6, 7, 8)

The method of claim 5, 6, 7 or 8, wherein the one or more sequences are the F and HN gene sequences of human PIV type 3.

### Claim 13 (depends on 5, 6, 7, 8)

The method of claim 5, 6, 7 or 8, wherein the one or more sequences are the F and FIN gene sequences of human RSV.

### Claim 14 (depends on 1, 2, 3, 4, 5)

The method of any one of claims 1, 2, 3, 4, 5 6 or 8, further comprising administering an adjuvant.

### Claim 15 (depends on 14)

The method of claim 14, wherein the adjuvant is a mineral gel, a surface active substance, a peptide, or an oil emulsion.

### Claim 16 (depends on 15)

The method of claim 15, wherein the adjuvant is aluminum hydroxide, lysolecithin, a pluronic polyoi, a polyanion, BCG or Corynebacterium parvum.

### Claim 17 (depends on 1, 2, 3, 4, 5, 6, 8)

The method of any one of claims 1, 2, 3, 4, 5, 6 or 8, wherein the chimeric parainfluenza virus is administered orally, intradermally, intramuscularly, intraperitoneally, subcutaneously, or intranasally.