# US 10,765,736 B2 · Vaccine composition containing synthetic adjuvant > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,736 B2 - Document ID: US10765736B2 - Status: Granted - Kind: B2 - Application number: 15/823,852 - Filed: 2017-11-28 - Published: 2018-08-09 - Granted: 2020-09-08 - Earliest claimed: 2006-09-26 - Assignees: Infectious Disease Research Institute - Applicants: Infectious Disease Research Institute - Inventors: Steven G. Reed; Darrick Carter - Web page: https://patentgrep.com/patent/US10765736B2 ## CPC - A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants - A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)} - A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53) - A61K 39/0011: {Cancer antigens} - A61K 39/008: Leishmania antigens - A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis - A61K 39/145: Orthomyxoviridae, e.g. influenza virus - A61K 39/35: Allergens - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics - A61P 31/06: for tuberculosis - A61P 31/08: for leprosy - A61P 31/16: for influenza or rhinoviruses - A61P 33/02: Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis - A61P 35/00: Antineoplastic agents - A61P 37/00: Drugs for immunological or allergic disorders - 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 2039/55511: {Organic adjuvants} - A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A} - Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change - 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 - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract Compositions and methods, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response are disclosed based on the discovery of useful immunological adjuvant properties in a synthetic, glucopyranosyl lipid adjuvant (GLA) that is provided in substantially homogeneous form. Chemically defined, synthetic GLA offers a consistent vaccine component from lot to lot without the fluctuations in contaminants or activity that compromise natural-product adjuvants. Also provided are vaccines and pharmaceutical compositions that include GLA and one or more of an antigen, a Toll-like receptor (TLR) agonist, a co-adjuvant and a carrier such as a pharmaceutical carrier. ## Claims ### Claim 1 A pharmaceutical composition comprising a glucopyranosyl lipid adjuvant (GLA) having the formula: where: R1, R3, R5 and R6 are C11-C20 alkyl; and R2 and R4 are C12-C20 alkyl; or a pharmaceutically acceptable salt thereof; at least one of a surfactant and a biodegradable oil; and a pharmaceutically acceptable carrier, excipient or diluent. ### Claim 2 (depends on 1) The composition of claim 1 in an emulsion form. ### Claim 3 (depends on 1) The composition of claim 1 in an oil-in-water emulsion form. ### Claim 4 (depends on 3) The composition of claim 3 comprising squalene. ### Claim 5 (depends on 1, 2, 3, 4) The composition of any one of claims 1-4 further comprising at least one additional component selected from the group consisting of: a toll-like receptor (TLR) agonist; a saponin or saponin mimetic; a co-adjuvant; and a carrier that comprises at least one of an oil and an immunostimulatory complex. ### Claim 6 (depends on 5) The composition of claim 5 wherein the saponin comprises QS21. ### Claim 7 (depends on 1, 2, 3, 4) The composition of any one of claims 1-4 comprising oil droplets having a size of less than 1 micron in diameter. ### Claim 8 (depends on 1) The composition of claim 1 in a liquid form. ### Claim 9 (depends on 1, 8) The composition of claim 1 or 8 in a solution form or in a suspension form. ### Claim 10 (depends on 1, 8) The composition of claim 1 or 8 comprising a stable aqueous suspension of particles of less than 0.2 μm diameter and at least one component selected from the group consisting of phospholipid, fatty acid, surfactant, detergent, saponin, and fluoridated lipid. ### Claim 11 (depends on 1, 8) The composition of claim 1 or 8 comprising liposomes. ### Claim 12 (depends on 1, 8) The composition of claim 1 or 8 comprising microspheres. ### Claim 13 (depends on 1) The composition of claim 1 in an aerosol form. ### Claim 14 (depends on 1) The composition of claim 1 in a lyophilizate form. ### Claim 15 (depends on 1, 2, 3, 4, 6, 8, 13, 14) The composition of any one of claims 1-4, 6, 8, 13 and 14 comprising a preservative, an antibacterial agent, or an antioxidant, or any combination of the foregoing. ### Claim 16 (depends on 1) The composition of claim 1 comprising a dispersing agent and/or a suspending agent. ### Claim 17 (depends on 1) The composition of claim 1 comprising a buffer. ### Claim 18 (depends on 1) The composition of claim 1 comprising sterile water. ### Claim 19 (depends on 1) The composition of claim 1 comprising alpha tocopherol. ### Claim 20 (depends on 1) The composition of claim 1 comprising a synthetic mono or diglyceride. ### Claim 21 (depends on 1) The composition of claim 1 comprising an aluminum salt. ### Claim 22 (depends on 1) The composition of claim 1 comprising a recombinant viral vector. ### Claim 23 (depends on 1) The composition of claim 1 comprising at least one of petrolatum, lanolin, polyethylene glycol, beeswax, and mineral oil. ### Claim 24 (depends on 1) The composition of claim 1 formulated for injection. ### Claim 25 (depends on 1, 2, 3, 4, 6, 8, 13, 14) The composition of any one of claims 1-4, 6, 8, 13 and 14, and 16-24 wherein: R1, R3, R5 and R6 are undecyl; and R2 and R4 are tridecyl. ### Claim 26 (depends on 1) The composition of claim 1 wherein the GLA is a pharmaceutically acceptable salt. ### Claim 27 (depends on 25) The composition of claim 25 wherein the GLA is a pharmaceutically acceptable salt.