# US 9,750,692 B2 · Liposomal vaccine compositions comprising a polysaccharide antigen and a protein adjuvant > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,750,692 B2 - Document ID: US9750692B2 - Status: Granted - Kind: B2 - Application number: 14/272,313 - Filed: 2014-05-07 - Published: 2014-09-04 - Granted: 2017-09-05 - Earliest claimed: 2005-09-30 - Assignees: Lipoxen Technologies Limited - Applicants: Lipoxen Technologies Limited - Inventors: Andrew David Bacon; Gregory Gregoriadis; Peter Laing - Web page: https://patentgrep.com/patent/US9750692B2 ## CPC - A61K 9/127: Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant - A61K 9/1272: comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers (lipids as modifying agents {A61K47/543}) - A61K 39/02: Bacterial antigens - A61K 39/092: {Streptococcus} - A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants - A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants - A61P 11/00: Drugs for disorders of the respiratory system - A61P 25/00: Drugs for disorders of the nervous system - A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics - A61P 31/04: Antibacterial agents - A61P 37/02: Immunomodulators - A61P 37/04: Immunostimulants - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61K 2039/55544: {Bacterial toxins} - A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers} - 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 A liposomal composition, preferably a vaccine, comprising liposomes formed of liposome forming compounds, containing coentrapped polysaccharide antigen and T-cell dependent protein carrier, such as tetanus toxoid or diphtheria toxin modified to render it non-toxic. The invention is of use in the production of vaccines against Haemophilus influenzae, Streptococcus pneumoniae or Neisseria meningitidis. ## Claims ### Claim 1 A liposomal composition comprising one or more polysaccharide antigens and a protein carrier coentrapped within liposomes; wherein the one or more polysaccharide antigens are water-soluble; wherein the protein carrier has at least one T-cell epitope, a molecular weight in the range of 75 kDa to 400 kDa, and is non-toxic; wherein the polysaccharide antigen and protein carrier are non-conjugated; and wherein the liposomes have an average diameter in the range of 50 nm to 700 nm and are formed from liposome forming compounds that have, in combination, no overall ionic charge and comprise at least one phospholipid. ### Claim 2 (depends on 1) The composition according to claim 1, wherein the liposome forming compounds comprise cholesterol, at least one cationically charged compound, or both. ### Claim 3 (depends on 2) The composition according to claim 2, wherein the at least one phospholipid includes phosphatidylcholine optionally in combination with phosphatidylethanolamine. ### Claim 4 (depends on 1) The composition according to claim 1, wherein the liposomes have an average diameter in the range 80-500 nm. ### Claim 5 (depends on 1) The composition according to claim 1, wherein the ratio of polysaccharide antigen to protein carrier is in the range 6:1 to 1:6. ### Claim 6 (depends on 1) The composition according to claim 1, wherein the protein is selected from ovalbumin, tetanus toxoid and diphtheria toxoid. ### Claim 7 (depends on 1) The composition according to claim 1, wherein the one or more polysaccharide antigens have no overall ionic charge. ### Claim 8 (depends on 1) The composition according to claim 1, wherein the one or more polysaccharide antigens are derived from an infectious agent. ### Claim 9 (depends on 1) The composition according to claim 1, which comprises more than one polysaccharide antigens. ### Claim 10 (depends on 9) The composition according to claim 9, wherein the more than one polysaccharide antigens are derived from the same bacterial species. ### Claim 11 (depends on 9) The composition according to claim 9, wherein each of the more than one polysaccharide antigens is encapsulated in a separate population of liposomes or are co-encapsulated in the same liposomes of the population. ### Claim 12 (depends on 1) The composition according to claim 1, additionally comprising one or more sugars. ### Claim 13 (depends on 1) The composition according to claim 1, which is a pharmaceutical composition and comprises a pharmaceutically acceptable diluent or excipient. ### Claim 14 (depends on 1) The composition according to claim 1, wherein the one or more polysaccharide antigens are entrapped in the intravesicular space of the liposomes. ### Claim 15 (depends on 1) The composition according to claim 1, wherein the protein carrier is entrapped in the intravesicular space. ### Claim 16 (depends on 1) A method for forming a liposomal composition as defined in claim 1, the method comprising the steps of: (i) mixing empty liposomes with one or more polysaccharide antigens and protein carrier; and (ii) drying the mixture from step (i). ### Claim 17 (depends on 16) The method according to claim 16, which further comprises the step of rehydrating the mixture from step (ii) to form a suspension of dehydration-rehydration vesicles (DRV). ### Claim 18 (depends on 17) The method according to claim 17, in which non-entrapped material is at least partially removed from the DRVs. ### Claim 19 (depends on 16) The method according to claim 16, wherein in step (i), a sugar is present in the mixture of empty liposomes, protein and polysaccharide antigen.