Process for ready-to-use PCV/M.Hyo combination vaccine
The present invention describes a process for the preparation of an antigen composition, which antigen composition can be used to prepare a ready-to-use vaccine for swine, for preventing or reducing infection by M. hyo or PCV2 and associated signs of disease. The process is characterised in that it comprises a step of admixing a PCV2 antigen to a pre-formed antigen/adjuvant complex of an M. hyo antigen adsorbed to an Aluminium-hydroxide adjuvant. This way a PCV2/ M. hyo combination vaccine can be prepared that is highly effective already after a single administration, against infection and disease by M. hyo and PCV2 either when in single or in combined infections. Also the vaccine has very good safety upon administration, is ready-to-use, and is economically feasible.
1. A process for preparing an antigen composition for a ready-to-use combination vaccine for swine, wherein the antigen composition comprises a Mycoplasma hyopneumoniae ( M. hyo ) antigen and a porcine circovirus type 2 (PCV2) antigen;
wherein the process comprises a step of admixing the PCV2 antigen to a pre-formed antigen/adjuvant complex of the M. hyo antigen adsorbed to an Aluminium-hydroxide adjuvant to form the antigen mixture;
wherein the pre-formed antigen/adjuvant complex is obtained by the steps of:
a) admixing the Aluminium-hydroxide adjuvant and the M. hyo antigen, in a watery carrier at a pH at which the Aluminium-hydroxide adjuvant is positively charged to form a mixture; and
b) incubating said mixture to allow the adsorption of the M. hyo antigen to the Aluminium-hydroxide adjuvant to form an antigen/adjuvant complex.
2. The process of claim 1 , wherein the M. hyo antigen is an M. hyo bacterin.
3. A process for preparing a vaccine comprising a step of admixing the antigen composition of claim 1 , and an additional adjuvant.
4. A process for preparing a vaccine, comprising a step of emulsifying the antigen composition of claim 1 , and a mineral oil, into an oil-in-water emulsion.
5. The process of claim 1 , wherein the PCV2 antigen is encoded by a PCV2 ORF2 coding sequence.
6. The process of claim 5 , wherein the PCV2 ORF2 antigen is a virus-like particle.
7. The process of claim 2 , wherein the PCV2 antigen is encoded by a PCV2 ORF2 coding sequence.
8. The process of claim 1 , wherein the watery carrier is a balanced salt solution.
9. The process of claim 8 , wherein the pH of the watery carrier is between 6 and 8.
10. The process of claim 1 , wherein said mixture is essentially free of other components.
11. The process of claim 1 , wherein said incubating is performed for 10-20 hours at room temperature.
12. The process of claim 11 , wherein said incubating comprises a gentle agitation of the said mixture.
13. An antigen composition obtained by a process according to claim 1 .
14. The antigen composition according to claim 13 , characterised in that at least 50% of the M. hyo antigen is located in the antigen/adjuvant complex.
15. The antigen composition according to claim 14 , characterised in that at least 50% of the protein binding capacity of the Aluminium-hydroxide adjuvant is used by the M. hyo antigen.
16. A ready-to-use vaccine for swine, for preventing or reducing infection by M. hyo or PCV2 and associated signs of disease, the vaccine comprising the antigen composition obtained by a process according to claim 1 , and an additional adjuvant.
17. The vaccine according to claim 16 , characterised in that the vaccine is an oil-in-water emulsion and the additional adjuvant is a mineral oil.
18. A vaccine according to claim 16 , characterised in that the vaccine comprises additional antigenic material that is derived from a micro-organism pathogenic to swine.
19. The antigen composition obtained by a process according to claim 1 , for use in a vaccine for swine for preventing or reducing infection by M. hyo or PCV2 and associated signs of disease.
20. A method for preventing or reducing infection by M. hyo or PCV2 in swine and associated signs of disease, the method comprising the administration of the vaccine according to claim 16 , to swine.