# US 8,784,843 B2 · Stabilizers for freeze-dried vaccines > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,784,843 B2 - Document ID: US8784843B2 - Status: Granted - Kind: B2 - Application number: 11/522,211 - Filed: 2006-09-15 - Published: 2010-10-14 - Granted: 2014-07-22 - Earliest claimed: 2005-09-16 - Assignees: Merial Limited - Applicants: Delphine Magali Belin-Poput; Noel Yves Henri Jean Genin - Inventors: Delphine Magali Belin-Poput; Noel Yves Henri Jean Genin - Web page: https://patentgrep.com/patent/US8784843B2 ## CPC - A61K 39/12: Viral antigens - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 39/155: Paramyxoviridae, e.g. parainfluenza virus - A61K 39/175: Canine distemper virus - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin - A61P 31/12: Antivirals - A61K 2039/5254: {avirulent or attenuated} - A61K 2039/552: {Veterinary vaccine} - C12N 2710/10334: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein - C12N 2750/14334: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein - C12N 2760/18434: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein - C12N 2760/18734: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein - 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 - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract The present invention relates generally to the fields of immunology and vaccine technology. More specifically, the present invention relates to stabilizers for freeze-dried live attenuated immunogenic and/or vaccine compositions, which may comprise, inter alia, canine paramyxovirus. The invention further relates to stabilized, freeze-dried live attenuated immunogenic and/or vaccine compositions of, for example, canine paramyxovirus, which may contain these stabilizers. Other aspects of the invention are described in or are obvious from the following disclosure, and are within the ambit of the invention. ## Claims ### Claim 1 A stabilizer for a freeze-dried live attenuated canine distemper (CDV) and canine parainfluenza type 2 (cPi2) immunogenic composition comprising at least one reducing monosaccharide and at least one acid antioxidant compound, wherein the at least one acid antioxidant compound consists of aspartic acid; and wherein the at least one reducing monosaccharide consists of glucose, galactose, fructose, mannose, sorbose, or combinations thereof; wherein the at least one reducing monosaccharide is at a concentration from 20% to 50% w/w and the at least one acid antioxidant is at a concentration from 1.5% to 6% w/w; and wherein the stabilizer further consists of: (a) a bulking agent selected from dextran, maltodextrin, polyvinylpymolidone, hydroxyethyl starch, and combinations thereof, or (b) a sugar alcohol selected from sorbitol, mannitol, xylitol, maltitol and combinations thereof, or (c) a combination thereof; and wherein the stabilizer is capable of reducing the amount of CDV and cPi2 titer lost during the freezing process by at least 0.5 logs. ### Claim 2 (depends on 1) The stabilizer of claim 1 wherein the reducing monosaccharide consists of glucose, galactose, or glucose combined with any one of galactose, fructose, mannose, or sorbose. ### Claim 3 (depends on 2) The stabilizer of claim 2 wherein the bulking agent is dextran present in an amount from about 10% to about 70% w/w. ### Claim 4 (depends on 3) The stabilizer of claim 3 wherein no sugar alcohol is present. ### Claim 5 (depends on 4) The stabilizer of claim 4 wherein and the reducing monosaccharide consists of glucose. ### Claim 6 (depends on 5) The stabilizer of claim 5 further comprising a non-reducing oligosaccharide, which consists of either raffinose or sucrose. ### Claim 7 (depends on 2) The stabilizer of claim 2 wherein the at least one reducing monosaccharide is glucose. ### Claim 8 (depends on 7) The stabilizer of claim 7 wherein the sugar alcohol consists of mannitol, sorbitol, or a combination thereof. ### Claim 9 (depends on 1) A liquid immunogenic composition comprising live attenuated paramyxoviruses comprising CDV and cPi2, mixed with the stabilizer of claim 1. ### Claim 10 (depends on 9) The immunogenic composition of claim 9, which further comprises at least one active immunogenic component derived from a pathogen other than paramyxovirus. ### Claim 11 (depends on 10) The immunogenic composition of claim 10, wherein (a) the at least one active immunogenic component is derived from a pathogen selected from Adenoviridae, Parvoviridae, Coronaviridae, Herpesviridae, Poxviridae, Rhabdoviridae, and combinations thereof; or (b) the at least one active immunogenic component is selected from live attenuated canine adenovirus type 2 (CAV2), live attenuated canine parvovirus (CPV), and combinations thereof; or (c) the at least one active immunogenic component is a viral vector comprising nucleotides encoding one or more heterologous, non-paramyxovirus immunogen(s); or (d) the at least one active immunogenic component is a plasmid vector comprising nucleotides encoding one or more heterologous non-paramyxovirus immunogen(s). ### Claim 12 (depends on 9) The immunogenic composition of claim 9, wherein the stabilizer components are present in the following w/v amounts, relative to the final liquid composition, prior to freeze-drying: (a) the reducing monosaccharide is present from about 1% to about 5% (w/v); (b) the aspartic acid is present from about 0.1% to about 0.2.5% or about 0.5% to about 7.5% (w/v); and (c) the bulking agent is present from about 1.5% to about 5% (w/v). ### Claim 13 (depends on 9) The immunogenic composition of claim 9, wherein the stabilizer components are present in the following w/v amounts, relative to the final liquid composition, prior to freeze-drying: (a) the reducing monosaccharide is present from about 1.5% to about 4% w/v; (b) the aspartic acid is present from about 0.5% to 7.5%; and (c) the sugar alcohol is present from about 0.5% to 5.0%. ### Claim 14 (depends on 9, 10, 11, 12, 13) A freeze-dried stabilized live attenuated CDV and cPi2 immunogenic composition produced by freeze-drying the liquid composition of any one of claims 9 to 13.