# US 2014/0193481 A1 · Stabilised vaccine composition > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0193481 A1 - Document ID: US20140193481A1 - Status: Published application - Kind: A1 - Application number: 14/086,038 - Filed: 2013-11-21 - Published: 2014-07-10 - Earliest claimed: 2007-12-21 - Assignees: Glaxosmithkline Biologicals SA - Applicants: GlaxoSmithKline Biologicals, s.a. - Inventors: Dominique Ingrid LEMOINE; Sophie Valerie Anne Ponsard - Web page: https://patentgrep.com/patent/US20140193481A1 ## CPC - A61K 31/713: Double-stranded nucleic acids or oligonucleotides - 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 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)} - A61K 39/12: Viral antigens - A61K 39/21: Retroviridae, e.g. equine infectious anemia virus - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids - A61P 31/18: for HIV - A61K 2039/5555: {Muramyl dipeptides} - A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A} - A61K 2039/55577: {Saponins; Quil A; QS21; ISCOMS} - A61K 2039/60: {characteristics by the carrier linked to the antigen} - C12N 2740/16034: 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 A component for a HIV vaccine comprising: a) an immunogenic fusion protein comprising Nef or an immunogenic fragment or derivative thereof, and p17 Gag and/or p24 Gag or immunogenic fragments or derivatives thereof, wherein when both p17 and p24 Gag are present there is at least one HIV antigen or immunogenic fragment between them, and b) a stabilising agent selected from the group comprising or consisting of monothioglycerol, cysteine, N-acetyl cysteine or mixtures thereof. The invention also extends to HIV vaccines comprising the same and use in treatment/prevention of HIV. ## Claims ### Claim 1 An immunogenic composition comprising: a) an immunogenic fusion protein a Nef polypeptide or immunogenic fragment thereof, a Gag polypeptide or immunogenic fragment thereof, and a reverse transcriptase (RT) polypeptide or immunogenic fragment thereof, and b) an antioxidant selected from the group consisting of monothioglycerol, cysteine, N-acetyl cysteine or mixtures thereof. ### Claim 2 (depends on 1) The immunogenic composition of claim 1, wherein the antioxidant is present in a concentration to provide a concentration in the final formulation of about 0.5% w/v. ### Claim 3 (depends on 1) The immunogenic composition of claim 1, which further comprises saccharose, dextrose, mannitol or fructose. ### Claim 4 (depends on 3) The immunogenic composition of claim 3, wherein the saccharose, dextrose, mannitol or fructose is present as 1 to 10% by weight of the final formulation. ### Claim 5 (depends on 1) The immunogenic composition of claim 1, which further comprises arginine. ### Claim 6 (depends on 5) The immunogenic composition of claim 5, wherein the arginine is present in a concentration of 200 to 400 mM. ### Claim 7 (depends on 1) The immunogenic composition of claim 1, which further comprises a chelating agent. ### Claim 8 (depends on 7) The immunogenic composition of claim 7, wherein the chelating agent is selected from the group consisting of citric acid trisodium salt, malic acid sodium salt, dextrose, L-methionine and EDTA disodium. ### Claim 9 (depends on 1) The immunogenic composition of claim 1, which further comprises a non-ionic surfactant. ### Claim 10 (depends on 9) The immunogenic composition of claim 9, wherein the non-ionic surfactant is polysorbate 80. ### Claim 11 (depends on 9) The immunogenic composition of claim 9, wherein the non-ionic surfactant is present at a concentration from about 0.005 to about 0.05% w/v in a final dose. ### Claim 12 (depends on 1) The immunogenic composition of claim 1, which further comprises a buffer. ### Claim 13 (depends on 12) The immunogenic composition of claim 12 wherein the buffer is a phosphate (PO4) buffer. ### Claim 14 (depends on 1) The immunogenic composition of claim 1 which further comprises a preservative. ### Claim 15 (depends on 14) The immunogenic composition of claim 14, wherein the preservative is thiomersal. ### Claim 16 An immunogenic composition comprising: a) an immunogenic fusion protein comprising a Nef polypeptide or immunogenic fragment thereof, a Gag polypeptide or immunogenic fragment thereof, and a reverse transcriptase (RT) polypeptide or immunogenic fragment thereof, b) a stabilising agent which is an antioxidant selected from the group consisting of monothioglycerol, cysteine, N-acetyl cysteine and mixtures thereof, c) 1% w/v or less of a non-ionic surfactant, d) 200 to 450 mM of arginine, e) 0.5 to 2.0 mM of a chelating agent, and f) 1 to 50 mM of a buffer. ### Claim 17 (depends on 1) A pharmaceutical composition comprising the immunogenic composition of claim 1. ### Claim 18 (depends on 17) The pharmaceutical composition of claim 17, which further comprises an adjuvant. ### Claim 19 (depends on 18) The pharmaceutical composition of claim 18, wherein the adjuvant comprises a TLR 4 agonist. ### Claim 20 (depends on 19) The pharmaceutical composition of claim 19, wherein the TRL 4 agonist is MPL. ### Claim 21 (depends on 18) The pharmaceutical composition of claim 18, wherein the adjuvant further comprises a saponin. ### Claim 22 (depends on 21) The pharmaceutical composition of claim 21, wherein the saponin is QS21. ### Claim 23 (depends on 18) The pharmaceutical composition of claim 18, wherein the adjuvant is provided as a liposomal formulation. ### Claim 24 (depends on 17) A method of treatment comprising administering a therapeutically effective amount of the pharmaceutical composition of claim 17 for the treatment or prophylaxis of HIV or AIDS. ### Claim 25 (depends on 1) A kit comprising a lyophilized component as defined in claim 1 and a separate container of adjuvant. ### Claim 26 (depends on 1) The immunogenic composition of claim 1, wherein the antioxidant is a stabilizing agent. ### Claim 27 (depends on 1) The immunogenic composition of claim 1, wherein the fusion polypeptide contains at least one HIV antigen between the p17 and the p24 polypeptides of Gag. ### Claim 28 (depends on 1) The fusion polypeptide of claim 1, wherein the RT polypeptide is p66. ### Claim 29 (depends on 1) The fusion polypeptide of claim 1, wherein the RT polypeptide is truncated at the C terminus such that it lacks the carboxy terminal RNase H domain. ### Claim 30 (depends on 1) The fusion polypeptide of claim 1, wherein the RT polypeptide is p51. ### Claim 31 (depends on 1) The fusion polypeptide of claim 1, wherein the RT polypeptide comprises a mutation at the amino acid position corresponding to position 592 in SEQ ID NO:2 where methionine is replaced by another amino acid residue.