Rotavirus subunit vaccines and methods of making and use thereof

Patent metadata

Field	Value
Publication number	US-9446117-B2
Application number	US-201313767569-A
Country	US
Kind code	B2
Filing date	Feb 14, 2013
Priority date	Feb 14, 2012
Publication date	Sep 20, 2016
Grant date	Sep 20, 2016

Abstract

The present invention provides Rotavirus antigenic polypeptides or antigens that elicit an immune response in animal or human against rotavirus, compositions comprising said rotavirus polypeptides, methods of vaccination against rotavirus, and kits for use with such methods and compositions. The invention further provide novel expression vectors for producing the vaccine antigenic polypeptides.

First claim

What is claimed is:

1. A safe and effective immunological composition comprising:
a) a recombinant, non-naturally-occurring fusion polypeptide, comprising an NSP4, a VP4 and a VP6 porcine rotavirus C polypeptide; and
b) a pharmaceutically or veterinary acceptable vehicle, diluent or excipient;

wherein the composition is effective in eliciting in a porcine animal a protective immune response against a subsequent virulent rotavirus challenge;
wherein the polypeptide has at least 95% sequence identity to the sequence set forth in Seq. Id. No.: 95; and
wherein the NSP4 polypeptide has at least 90% identity to the sequence set forth in Seq. Id. No.: 18, the VP4 polypeptide has at least 90% identity to the sequence set forth in Seq. Id. No.: 42, and the VP4 polypeptide has at least 90% identity to the sequence set forth in Seq. Id. No.: 52.

2. The composition of claim 1 further comprising an adjuvant.

3. The composition of claim 2 wherein the adjuvant is an oil-in-water adjuvant.

4. A safe and effective immunological composition comprising:
a) a recombinant, non-naturally-occurring triple polypeptide, consisting essentially of a rotavirus C NSP4-VP4-VP6 triple fusion protein having the sequence set forth in SEQ ID NO:95; and
b) a pharmaceutically or veterinary acceptable vehicle, diluent or excipient;
c) an adjuvant comprising mineral oil and surfactants; and

wherein the composition is effective in eliciting in a porcine animal in need thereof a protective immune response that is protective against a subsequent virulent rotavirus challenge.

5. The composition of claim 4 , further comprising at least one additional antigen associated with a pathogen other than rotavirus.

6. The composition of claim 5 , wherein the at least one additional antigen elicits in a porcine an immune response against Mycoplasma hyopneumoniae ( M. hyo ), Porcine Circovirus Type 2 (PCV2), Porcine reproductive and respiratory syndrome virus (PRRSV), Swine influenza virus (SIV) or other pathogen capable of infecting and causing illness or susceptibility to illness in a porcine.

7. A method of vaccinating a procine animal, comprising administering to the animal at least one dose of the composition of claim 4 .

8. The method of claim 7 , wherein the porcine is a sow from about 3 weeks to about 6 weeks prefarrowing.

9. The method of 8 , wherein the resulting piglets have a reduced morbidity and/or mortality as compared to piglets coming from unvaccinated sows.

Assignees

• Bey Russell F
• Simonson Randy S
• Sirigireddy Kamesh Reddy
• Hause Benjamin Matthew
• Merial Inc

Inventors

• Bey Russell F
• Simonson Randy S
• Sirigireddy Kamesh Reddy
• Hause Benjamin Matthew

Classifications

• A61P37/00

  Drugs for immunological or allergic disorders · CPC title

• A61P37/04

  Immunostimulants · CPC title

• A61P31/14

  for RNA viruses · CPC title

• A61K2039/5258

  Virus-like particles · CPC title

• A61K39/21

  Retroviridae, e.g. equine infectious anemia virus · CPC title