Claims
- 1. An immunogenic composition, which comprises:
a genetically-detoxified pertussis holotoxin, and at least one other, non-Bordetella, antigen, wherein said genetically-detoxified pertussis holotoxin is present in an amount sufficient to modulate an immune response to said other antigen in the absence of an extrinsic adjuvant.
- 2. The composition of claim 1 wherein said immune response is selected from a humoral response, a cellular response and both a humoral and a cellular response.
- 3. The composition of claim 1 wherein said modulated immune response to said other antigen is selected from an enhanced IgG response, a cellular response and both an enhanced IgG and a cellular response.
- 4. The composition of claim 1 wherein said other antigen provides a protective immune response to at least one pathogen.
- 5. The composition of claim 4 wherein said pathogen is selected from the group consisting of bacterial, viral and parasitic pathogens.
- 6. The composition of claim 5 wherein said at least one pathogen is selected from the group consisting of Corynebacterium diphtheria, Clostridium tetani, paramyxoviridae, haemophilus, influenza, hepatitis, meningococci, streptococci, schistosoma and trypanosoma.
- 7. The composition of claim 6 wherein said genetically-detoxified pertussis holotoxin is immunoprotective.
- 8. The composition of claim 4 wherein said other antigen is a cancer-associated antigen.
- 9. The composition of claim a wherein said cancer is selected from melanoma, bladder, lung, cervical and prostate cancer.
- 10. The composition of claim 1 wherein such other antigen comprises inactivated tumor cells or membrane fraction thereof.
- 11. The composition of claim 10 wherein said cells are inactivated by irradiation.
- 12. The composition of claim 1 wherein at least one amino acid is removed or replaced in said genetically-detoxified pertussis holotoxin.
- 13. The composition of claim 12 wherein multiple amino acids are removed and replaced in said genetically-detoxified pertussis holotoxin.
- 14. The composition of claim 12 or 13 wherein said at least one amino acid is selected from the group consisting of (S1) ARG9, ARG13, TRP26, ARG58 and GLU129.
- 15. The composition of claim 13 wherein said multiple amino acids are (S1) ARG9, GLU129.
- 16. The composition of claim 15 wherein said multiple amino acids are replaced (S1) ARG9 to LYS9 and GLU129 to GLY129.
- 17. The composition of claim 1 wherein said genetically-detoxified pertussis holotoxin is selected from those listed in Tables 1a, 2 and 3.
- 18. The composition of claim 1 containing at least one additional Bordetella antigen.
- 19. The composition of claim 18 wherein said Bordetella antigen is selected from the group consisting of agglutinogens, FHA and pertactin.
- 20. The immunogenic composition of claim 1 which is formulated in the substantial absence of an extrinsic adjuvant as a vaccine for human or animal administration.
- 21. The immunogenic composition of claim 20 wherein said composition exhibits a decreased IgE response.
- 22. The immunogenic composition of claim 1 which is formulated in the substantial absence of alum as a multivalent vaccine comprising said genetically-detoxified pertussis holotoxin in an immunoprotective form and amount and diphtheria toxoid and tetanus toxoid as said at least one other, non-Bordetella, antigen.
- 23. The immunogenic composition of claim 22 which further comprises at least an additional Bordetella antigen.
- 24. The immunogenic composition of claim 23 wherein said additional Bordetella antigen is selected from the group consisting of agglutinogens, FHA and pertactin.
- 25. A method of obtaining a modulated immune response to an antigen in a host, which comprises:
administering at least one non-Bordetella antigen to said host, and coadministering to said host a genetically-detoxified holotoxin in an amount sufficient to modulate an immune response to said other antigen in the absence of an extrinsic adjuvant.
- 26. The method of claim 25 wherein said immune response is selected from a humoral response, a cellular response and both a humoral and a cellular response.
- 27. The method of claim 25 wherein said modulated immune response to said non-Bordetella antigen is selected from an enhanced IgG response, a cellular response and both an enhanced IgG and a cellular response.
- 28. The method of claim 25 wherein said administration and coadministration are effected by administering a composition as claimed in claim 1 to 22 to said host in the absence of an extrinsic adjuvant.
- 29. The method of claim 25 wherein said host is a human.
REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of copending U.S. patent application Ser. No. 08/258,228 filed Jun. 10, 1994.
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
08258228 |
Jun 1994 |
US |
Child |
08481878 |
Jun 1995 |
US |