Vaccine compositions and methods

Abstract

The present invention relates to pharmaceutical vaccine compositions comprising at least one vaccine antigen together with living immune cells. These immune cells include at least a portion of activated T-cells and act as an adjuvant. Methods for using these pharmaceutical compositions to prevent or treat diseases, such as cancer, infectious diseases and autoimmune disease are also included.

1 . A pharmaceutical composition comprising an adjuvant combined with one or more antigens, wherein the adjuvant comprises living immune cells where at least a portion are activated T-cells and administration of the composition to a host generates a Th-1 response. 
     
     
         2 . The composition of  claim 1  wherein the T-cells are memory T-cells of the Th-1 phenotype. 
     
     
         3 . The composition of  claim 1  wherein the T-cells are activated by the cross-linking of CD3 and CD28 surface molecules on the T-cells. 
     
     
         4 . The composition of  claim 1  wherein the activated T-cells express CD40L. 
     
     
         5 . The composition of  claim 1  wherein the T-cells are allogeneic to the host. 
     
     
         6 . The composition of  claim 1  wherein at least two antigens are combined with the adjuvant. 
     
     
         7 . The composition of  claim 1  wherein the one or more antigens are from an antigen source selected from whole cells, organisms, lysates of whole cells or organisms, naked DNA or RNA, nuclear materials, peptides or proteins, antibodies, antigen pulsed or transfected dendritic cells. 
     
     
         8 . The composition of  claim 1  wherein the one or more antigens comprises one or more tumor associated antigens. 
     
     
         9 . The composition of  claim 1  wherein the one or more antigens comprises one or more heat shock proteins. 
     
     
         10 . The composition of  claim 1  wherein the source of one or more antigens is a malignant tumor. 
     
     
         11 . The composition of  claim 1  wherein the source of the one or more antigens is from a pathogen. 
     
     
         12 . An adjuvant composition comprising living immune cells wherein at least a portion of the immune cells are activated T-cells and wherein the administration of the adjuvant composition to a host elicits a Th-1 immune response. 
     
     
         13 . The composition of  claim 12  wherein the T-cells are activated by cross-linking of the CD3 and CD28 surface molecules on the T-cells. 
     
     
         14 . The composition of  claim 12  wherein the T-cells express CD40L. 
     
     
         15 . A method of making a pharmaceutical composition comprising:
 preparing an adjuvant comprising living immune cells wherein the immune cells comprise at least a portion of T-cells; and   combining one or more antigens with the adjuvant, wherein the pharmaceutical composition, upon administration to a host, stimulates an immune response in the host.   
     
     
         16 . The method of  claim 15  wherein the adjuvant and the one or more antigens are combined prior to administration to the host. 
     
     
         17 . The method of  claim 15  wherein the immune response generated is a Th1 response. 
     
     
         18 . The method of  claim 15  wherein the T-cells are memory T-cells of the Th-1 phenotype. 
     
     
         19 . The method of  claim 15  wherein the T-cells are activated T-cells. 
     
     
         20 . The method of  claim 15  wherein the T-cells are activated by the cross-linking of CD3 and CD28 surface molecules on the T-cells. 
     
     
         21 . The method of  claim 15  wherein the activated T-cells express CD40L. 
     
     
         22 . The method of  claim 15  wherein the T-cells are allogeneic to the host. 
     
     
         23 . The method of  claim 15  wherein at least two antigens are combined with the adjuvant. 
     
     
         24 . The method of  claim 15  wherein the one more antigens are selected from one or more antigenic sources. 
     
     
         25 . The method of  claim 15  wherein the antigenic sources are selected from whole cells, organisms, lysates of whole cells or organisms, naked DNA or RNA, nuclear materials, antibodies, antigen pulsed or transfected dendritic cells. 
     
     
         26 . The method of  claim 15  wherein the one or more antigens are tumor associated antigens. 
     
     
         27 . The method of  claim 15  wherein the one or more antigens are heat shock proteins. 
     
     
         28 . The method of  claim 15  wherein the one or more antigens is from a malignant tumor. 
     
     
         29 . The method of  claim 15  wherein the one or more antigens are from a disease causing agent. 
     
     
         30 . A method of reducing antigens related to or causing a disease in a host comprising:
 administering a pharmaceutical composition comprising an adjuvant and one or more antigens, the adjuvant comprising living immune cells wherein the immune cells comprise at least a portion of T-cells, and wherein the pharmaceutical composition, upon administration to the host, stimulates an immune response in the host.   
     
     
         31 . The method of  claim 30  wherein the T-cells are activated T-cells. 
     
     
         32 . The method of  claim 30  wherein the activated T-cells express CD40L. 
     
     
         33 . The method of  claim 30  wherein the T-cells are allogeneic to the host. 
     
     
         34 . The method of  claim 30  wherein the pharmaceutical composition includes at least two antigens. 
     
     
         35 . The method of  claim 30  wherein the one or more antigens are tumor associated antigens. 
     
     
         36 . The method of  claim 30  wherein the one or more antigens are heat shock proteins. 
     
     
         37 . The method of  claim 30  wherein the one or more antigens are from a malignant tumor. 
     
     
         38 . The method of  claim 30  wherein the one or more antigens are from a disease causing antigen. 
     
     
         39 . The method of  claim 30  further comprising administering a booster composition. 
     
     
         40 . The method of  claim 39  wherein the booster comprises living immune cells wherein at least a portion are activated T-cells. 
     
     
         41 . The method of  claim 39  wherein the booster comprises living immune cells wherein at least a portion are activated T-cells and one or more antigens. 
     
     
         42 . The method of  claim 30  wherein the adjuvant and the one or more antigens are combined prior to administering to the host. 
     
     
         43 . The method of  claim 30  wherein the adjuvant and the one or more antigens are administered sequentially to the host. 
     
     
         44 . A method of treating a disease in a patient comprising administering a pharmaceutical composition comprising an adjuvant and one or more antigens, the adjuvant comprising living immune cells wherein the immune cells comprise at least a portion of T-cells, and wherein the pharmaceutical composition, upon administration to the patient, stimulates an immune response in the host. 
     
     
         45 . The method of  claim 44  wherein the T-cells are activated T-cells. 
     
     
         46 . The method of  claim 44  wherein the disease is a cancer. 
     
     
         47 . The method of  claim 44  wherein the disease is caused by an infectious pathogen.