Vaccine Comprising an Oil in Water Emulsion Adjuvant

Abstract

The present invention provides an immunogenic composition comprising an antigen or antigen composition and an adjuvant composition comprising an oil in water emulsion, wherein said oil in water emulsion comprises 0.5-10 mg metabolisable oil, 0.5-11 mg tocol and 0.1-4 mg emulsifying agent, per human dose.

1 . An immunogenic composition comprising an antigen or antigen composition and an adjuvant composition comprising an oil in water emulsion, wherein said oil in water emulsion comprises 0.5-10 mg metabolisable oil, 0.5-11 mg tocol and 0.1-4 mg emulsifying agent, per human dose. 
     
     
         2 . An immunogenic composition comprising an antigen or antigen composition and an adjuvant composition consisting of an oil in water emulsion, wherein said oil in water emulsion comprises 0.5-10 mg metabolisable oil, 0.5-11 mg tocol and 0.1-4 mg emulsifying agent, per human dose. 
     
     
         3 . An immunogenic composition comprising an antigen or antigen composition and an adjuvant composition comprising an oil in water emulsion comprising one or more further immunostimulants, wherein said oil in water emulsion comprises 0.5-10 mg metabolisable oil, 0.5-11 mg tocol and 0.1-4 mg emulsifying agent, per human dose. 
     
     
         4 . A vaccine composition comprising an antigen or antigen composition and an adjuvant composition comprising an oil in water emulsion, wherein said oil in water emulsion comprises 0.5-10 mg metabolisable oil, 0.5-11 mg tocol and 0.1-4 mg emulsifying agent, per human dose. 
     
     
         5 . An immunogenic composition according to  claims 1 - 4  wherein the oil in water emulsion comprises 1-10, 2-10, 3-9, 4-8. 5-7, or 5-6 mg (e.g. 2-3, 5-6, or 9-10 mg) metabolisable oil, per human dose. 
     
     
         6 . An immunogenic composition according to  claims 1 - 5  wherein the oil in water emulsion comprises 0.5-11, 1-11, 2-10, 3-9, 4-8, 5-7, 5-6 (e.g. 10-11, 5-6, 2.5-3.5 or 1-3 mg) tocol, per human dose. 
     
     
         7 . An immunogenic composition according to  claims 1 - 6  wherein the oil in water emulsion comprises 0.1-5, 0.2-5, 0.3-4, 0.4-3 or 2-3 mg (e.g. 0.4-1.2, 2-3 or 4-5 mg) emulsifying agent, per human dose. 
     
     
         8 . An immunogenic composition according to  claims 1 - 7  wherein the amount of metabolisable oil is 5.35 mg, per human dose. 
     
     
         9 . An immunogenic composition according to  claims 1 - 8  wherein the amount of metabolisable oil is 2.14 mg, per human dose. 
     
     
         10 . An immunogenic composition according to  claims 1 - 9  wherein the amount of tocol is 5.94 mg, per human dose. 
     
     
         11 . An immunogenic composition according to  claims 1 - 10  wherein the amount of tocol is 2.38 mg, per human dose. 
     
     
         12 . An immunogenic composition according to  claims 1 - 11  wherein the amount of emulsifying agent is 2.425 mg, per human dose. 
     
     
         13 . An immunogenic composition according to  claims 1 - 12  wherein the amount of emulsifying agent is 0.97 mg, per human dose. 
     
     
         14 . An immunogenic composition according to  claims 1 - 13  wherein the metabolisable oil is squalene. 
     
     
         15 . An immunogenic composition as claimed in any of  claims 1 - 14  wherein the tocol is alpha-tocopherol. 
     
     
         16 . An immunogenic composition as claimed in any of  claims 1 - 15  wherein the emulsifying agent is polyoxyethylene sorbitan monooleate. 
     
     
         17 . An immunogenic composition as claimed in  claim 16  wherein the polyoxyethylene sorbitan monooleate is selected from the group comprising: Polysorbate® 80 or Tween® 80. 
     
     
         18 . An immunogenic composition according to any of the preceding claims wherein the vaccine composition volume is between 0.4 and 1.5 ml 
     
     
         19 . An immunogenic composition according to  claim 18  wherein said dose volume is 0.5 ml. 
     
     
         20 . An immunogenic composition according to  claim 18  wherein said dose volume is 0.7 ml. 
     
     
         21 . An immunogenic composition according to  claim 18  wherein said dose volume is 1.0 ml. 
     
     
         22 . An immunogenic composition according to any of the preceding claims wherein the antigen or antigenic composition is prepared from one or more antigens selected from the group comprising: HIV-1, human herpes viruses, cytomegalovirus, SARS coronavirus, Rotavirus, Epstein Barr virus (such as gp350 or derivatives thereof), Varicella Zoster Virus, hepatitis B virus, hepatitis A virus, hepatitis C virus and hepatitis E virus, paramyxoviruses: Respiratory Syncytial virus, parainfluenza virus, measles virus, mumps virus, human papilloma viruses, flaviviruses, Influenza virus (whole live or inactivated virus, split influenza virus, grown in eggs or MDCK cells, or whole flu virosomes (as described by R. Gluck, Vaccine, 1992, 10, 915-920) or purified or recombinant proteins thereof, such as HA, NP, NA, or M proteins, or combinations thereof), or derived from bacterial pathogens such as  Neisseria  spp;  S. pyogenes, S. agalactiae, S. mutans; H. ducreyi; Moraxella  spp;  Bordetella  spp;  Mycobacterium  spp.;  Legionella  spp;  Escherichia  spp;  Vibrio  spp;  Shigella  spp;  Yersinia  spp;  Campylobacter  spp.;  Salmonella  spp;  Listeria  spp.;  Helicobacter  spp.;  Pseudomonas  spp.;  Staphylococcus  spp.;  Enterococcus  spp.;  Clostridium  spp;  Bacillus  spp;  Corynebacterium  spp.;  Borrelia  spp.;  Rickettsia  spp;  Chlamydia  spp.;  Leptospira  spp.;  Treponema  spp.;  Plasmodium  spp.;  Toxoplasma; Entamoeba  spp.;  Babesia  sppi;  Trypanosoma  spp.i;  Giardia  spp.;  Leshmania  spp.;  Pneumocystis  spp;  Trichomonas  spp.;  Schisostoma spp, Candida  spp;  Cryptococcus  spp, allergen specific and allergen non-specific antigens, tumour antigens such as prostrate, breast, colorectal, lung, pancreatic, renal, ovarian or melanoma cancer antigens. 
     
     
         23 . A method of treating or preventing disease comprising administering to a patient suffering from or susceptible to disease an immunogenic composition according to any one of  claims 1 - 22 . 
     
     
         24 . An immunogenic composition according to any one of  claims 1  to  23  for use in the prophylactic therapy or therapy of a condition or disease. 
     
     
         25 . Use of an immunogenic composition according to any of  claims 1  to  22  in the manufacture of a medicament for use in prophylactic therapy or therapy of a condition or disease. 
     
     
         26 . Use of  claim 24  or  25  wherein the adjuvant composition further comprises one or more immunostimulants. 
     
     
         27 . An adjuvant composition comprising of an oil in water emulsion, wherein said oil in water emulsion comprises 0.5-10 mg metabolisable oil, 0.5-11 mg tocol and 0.1-4 mg emulsifying agent, per human dose. 
     
     
         28 . An adjuvant composition consisting of an oil in water emulsion, wherein said oil in water emulsion comprises 0.5-10 mg metabolisable oil, 0.5-11 mg tocol and 0.1-4 mg emulsifying agent, per human dose. 
     
     
         29 . An adjuvant composition comprising an oil in water emulsion comprising one or more further immunostimulants, wherein said oil in water emulsion comprises 0.5-10 mg metabolisable oil, 0.5-11 mg tocol and 0.1-4 mg emulsifying agent, per human dose. 
     
     
         30 . An adjuvant composition according to  claims 27 - 29  wherein the oil in water emulsion comprises 1-10, 2-10, 3-9, 4-8. 5-7, or 5-6 mg (e.g. 2-3, 5-6, or 9-10 mg) metabolisable oil, per human dose. 
     
     
         31 . An adjuvant composition according to  claims 27 - 30  wherein the oil in water emulsion comprises 0.5-11, 1-11, 2-10, 3-9, 4-8, 5-7, 5-6 (e.g. 10-11, 5-6, 2.5-3.5 or 1-3 mg) tocol, per human dose. 
     
     
         32 . An adjuvant composition according to  claims 27 - 31  wherein the oil in water emulsion comprises 0.1-5, 0.2-5, 0.3-4, 0.4-3 or 2-3 mg (e.g. 0.4-1.2, 2-3 or 4-5 mg) emulsifying agent, per human dose. 
     
     
         33 . A adjuvant composition according to  claims 27 - 32  wherein the amount of metabolisable oil is 5.35 mg, per human dose. 
     
     
         34 . An adjuvant composition according to  claims 27 - 33  wherein the amount of metabolisable oil is 2.14 mg, per human dose. 
     
     
         35 . An adjuvant composition according to  claims 27 - 34  wherein the amount of tocol is 5.94 mg, per human dose. 
     
     
         36 . A adjuvant composition according to  claims 27 - 35  wherein the amount of tocol is 2.38 mg, per human dose. 
     
     
         37 . A adjuvant composition according to  claims 27 - 36  wherein the amount of emulsifying agent is 2.425 mg, per human dose. 
     
     
         38 . An adjuvant composition according to  claims 27 - 37  wherein the amount of emulsifying agent is 0.97 mg, per human dose. 
     
     
         39 . An adjuvant composition according to  claims 27 - 38  wherein the metabolisable oil is squalene. 
     
     
         40 . An adjuvant composition as claimed in any of  claims 27 - 39  wherein the tocol is alpha-tocopherol. 
     
     
         41 . An adjuvant composition as claimed in any of  claims 27 - 40  wherein the emulsifying agent is polyoxyethylene sorbitan monooleate. 
     
     
         42 . An adjuvant composition as claimed in  claim 41  wherein the polyoxyethylene sorbitan monooleate is selected from the group comprising: Polysorbate® 80 or Tween® 80.