Feline vaccine compositions and method for preventing chlamydia infections or diseases using the same

Abstract

This invention provides a feline vaccine composition comprising an immunogenically active component having inactivated mammalian chlamydial cells or antigens derived therefrom, in combination with an effective amount of an immunogencally suitable adjuvant; and a veterinary pharmaceutically acceptable carrier or diluent. The vaccine composition is useful to prevent chlamydia, e.g. C. psittaci, infections or diseases in felines, and may also be combined with other vaccine compositions or therapy. A process for producing C. psittaci suitable for use in the production of safe and effective chlamydia vaccines, and a method for preventing chlamydia infections or diseases in felines, are also provided.

1 . A vaccine composition against feline  Chlamydia psittaci  infections comprising an immunogenically active component consisting of outer membrane antigens derived from inactivated feline  Chlamydia psittaci  in a dose of at least 50-1,000 ug/dose, an adjuvant, and a veterinary pharmaceutically acceptable carrier or diluent therefor, wherein said vaccine composition is purified of toxic immunogenic egg yolk sac substances, said vaccine composition prepared by the process comprising: 
 (a) culturing the feline  Chlamydia psittaci  in egg yolk sac;    (b) subculturing said egg yolk sac culture containing the feline  Chlamydia psittaci  in a suitable cell line to remove toxic immunogenic substances present in the egg yolk sac culture;    (c) harvesting the feline  Chlamydia psittaci  from the contents of the subculture, said contents selected from the group consisting of infected cell line cells, subculture supernatant and a combination thereof;    (d) inactivating the feline  Chlamydia psittaci  with inactivating agents;    (e) extracting outer membrane antigens from the inactivated feline  Chlamydia psittaci;  and    (f) mixing the inactivated feline  Chlamydia psittaci  with the adjuvant and physiologically acceptable carrier or diluent.    
     
     
         2 . A vaccine composition of  claim 1 , wherein said feline  Chlamydia psittaci  are isolated from feline specimens selected from the group consisting of vaginal, cervical, nasal, ocular, pneumonic, gastral fluids, secretions, discharges or scrapings, and combinations of any of the foregoing.  
     
     
         3 . The vaccine of  claim 1 , wherein the cell line subculture is harvested up to six times comprising the steps of: 
 (i) adding new chlamydia propagation media to the cell line subculture following the first harvest;    (ii) incubating the cell line subculture;    (iii) harvesting the feline  Chlamydia psittaci  from the contents of the subculture, said contents selected from the group consisting of infected cell line cells, subculture supernatant and a combination thereof; and    (iv) repeating steps (i)-(iii) up to five times.    
     
     
         4 . A vaccine composition of  claim 1 , wherein said adjuvant is selected from the group consisting of surfactants, polyanions, polycations, peptides, tuftsin, mineral oil emulsions, immunomodulators, ethylene/maleic anhydride copolymer, copolymer of styrene with a mixture of acrylic acid and methylacrylic acid and combinations of any of the foregoing.  
     
     
         5 . A vaccine composition of  claim 4 , wherein said adjuvant is one of ethylene/maleic anhydride copolymer, copolymer of styrene with a mixture of acrylic acid and methylacrylic acid, mineral oil emulsion or a combination of any of the foregoing.  
     
     
         6 . A vaccine composition of  claim 1 , wherein said adjuvant is one of saponin and aluminum phosphate or a combination thereof.  
     
     
         7 . A vaccine composition of  claim 1 , wherein said adjuvant comprises from 0.01 to 50% w/v or v/v.  
     
     
         8 . A vaccine composition of  claim 1 , wherein said veterinary pharmaceutically acceptable carrier or diluent comprises saline or Eagle's minimum essential media.  
     
     
         9 . A vaccine composition of  claim 1 , wherein said immunogenically active component is incorporated into liposomes.  
     
     
         10 . A vaccine composition of  claim 1 , wherein said immunogenically active component is incorporated into sustained release polymer(s).  
     
     
         11 . A vaccine composition of  claim 1 , wherein said immunogenically active component is conjugated to a biological compound selected from the group consisting of polysaccharides, peptides, proteins, and combinations of any of the foregoing.  
     
     
         12 . A vaccine composition of  claim 1 , in a dosage unit form derived from at least 2×10 4  inactivated feline  Chlamydia psittaci.    
     
     
         13 . A vaccine composition of  claim 1 , in parenteral injectable form.  
     
     
         14 . A method of preventing feline  Chlamydia psittaci  infection in felines comprising administering to a feline in need of such prevention of effective amount of the vaccine composition of  claim 1 .  
     
     
         15 . A method of  claim 14 , wherein the vaccine composition is parenterally administered.  
     
     
         16 . A method of  claim 15 , wherein said parenteral administration is carried out subcutaneously.  
     
     
         17 . A method of  claim 15 , wherein said parenteral administration is carried out intramuscularly.  
     
     
         18 . A method according to  claim 14 , wherein said vaccine composition is administered at least two times, each administration separated by about 14 to about 30 days.  
     
     
         19 . A multi-vaccine composition comprising the vaccine composition of  claim 1 , and at least one vaccine composition directed against a pathogen selected from the group consisting of feline leukemia, panleukopenia, calici, rhinotracheitis, feline acquired immunodeficiency disease, rabies, feline infectious peritonitis, toxoplasmosis, and  Borrelia burgdorferi,  and combinations of any of the foregoing.  
     
     
         20 . A vaccine composition comprising an immunogenically active component consisting of outer membrane antigens derived from inactivated feline  Chlamydia psittaci  in a dose of at least 50-1,000 ug/dose, an adjuvant and a veterinary pharmaceutically acceptable carrier or diluent therefor, wherein said vaccine composition is purified of toxic immunogenic yolk sac substances.  
     
     
         21 . The vaccine of  claim 1 , wherein said subculturing comprises one passage in a suitable cell line.  
     
     
         22 . The vaccine of  claim 1 , wherein said suitable cell line comprises dog kidney cells.  
     
     
         23 . A vaccine composition of  claim 23 , wherein the inactivating agents are selected from the group consisting of binary ethylenimine, beta-propriolactone, formalin, merthiolate consisting of thimerosal and sodium ethyl-mercurithio-salicylate, thimerosal, glutaraldehyde, sodium dodecyl sulfate, an alkylaryl polyether alcohol surfactant, and combinations thereof.  
     
     
         24 . A vaccine composition of  claim 23 , wherein said inactivating agent is thimerosal.