Extracellular Matrix Materials as Vaccine Adjuvants for Diseases Associated with Infectious Pathogens or Toxins

Abstract

Disclosed are vaccines and vaccine adjuvants useful in the treatment and/or prevention of infection and diseases associated with infectious pathogens, such as tetanus, as well as diseases associated with biological toxins. Also provided are methods of preparing an adjuvant and the vaccine containing the adjuvant. Methods are also provided for vaccinating/immunizing an animal against infection and diseases associated with infectious pathogens, such as tetanus, and other diseases associated with biological toxins. Adjuvant materials are presented that are prepared from an extracellular matrix material. The adjuvants are demonstrated to enhance the immunogenicity of an infectious pathogen antigen or biological toxin antigen of interest, as well as to enhance the survival of an immunized animal.

1 . A method for immunizing an animal against an infectious pathogen of interest comprising:
 administering to an animal an immunogenic amount of a composition comprising an antigen of an infectious pathogen of interest and an adjuvant, wherein said adjuvant comprises an extracellular matrix and is essentially free of alum, to provide an immunized animal; and   eliciting an immunologically detectable titer of antibodies specific for the infectious pathogen in said animal.   
     
     
         2 . The method of  claim 1  wherein the infectious pathogen antigen of interest comprises a tetanus toxoid preparation. 
     
     
         3 . The method of  claim 2  wherein the immunogenic amount of the composition comprises 0.03 μg to 0.05 μg of the tetanus toxoid. 
     
     
         4 . The method of  claim 1  wherein the immunized animal has an enhanced survival rate upon exposure to the infectious pathogen of interest compared to an animal not receiving the 
     
     
         5 . The method of  claim 1  wherein the composition comprises an antigen of interest for immunizing an animal against tetanus, influenza, rabies, viral hepatitis, diphtheria, anthrax,  Streptococcus pneumoniae  infection, malaria, leishmaniasis, ricin toxicosis, prions, or Staphylococcal enterotoxin B toxicosis. 
     
     
         6 . The method of  claim 1  wherein the extracellular matrix comprises small intestinal submucosa (SIS). 
     
     
         7 . The method of  claim 1  wherein the extracellular matrix comprising renal capsule tissue. 
     
     
         8 . The method of  claim 1  wherein the extracellular matrix comprises fascial extracellular matrix. 
     
     
         9 . The method of  claim 1  wherein the antigen preparation of interest comprises an inactivated preparation of the antigen of interest. 
     
     
         10 . The method of  claim 1  wherein the extracellular matrix comprises porcine small intestinal submucosa. 
     
     
         11 . The method of  claim 1  wherein the adjuvant comprises a 1:10 ratio of the extracellular matrix and a pharmaceutically acceptable carrier solution. 
     
     
         12 . The method of  claim 11  wherein the pharmaceutically acceptable carrier solution is sterile saline. 
     
     
         13 . The method of  claim 1  wherein the animal is immunized by oral administration or injection of the composition. 
     
     
         14 . The method of  claim 1  wherein the composition is administered by intramuscular injection or by subcutaneous injection. 
     
     
         15 . A method for protecting an animal against infection from an infectious pathogen of interest comprising:
 preparing a composition comprising an antigen or toxin from an infectious pathogen of interest and an extracellular matrix, wherein said composition is essentially free of alum; and   administering the composition to an animal to provide a treated animal,   
       wherein survival rate to a lethal dose of the infectious pathogen of interest is essentially the same in the treated animal and an animal receiving a composition consisting of the antigen or toxin from an infectious pathogen of interest with alum. 
     
     
         16 . The method of  claim 15  wherein the toxin is tetanus toxoid. 
     
     
         17 . The method of  claim 16  wherein the extracellular matrix comprises small intestinal submucosal tissue (SIS). 
     
     
         18 . The method of  claim 17  comprising a particulate small intestinal submucosal tissue (SIS). 
     
     
         19 . The method of  claim 15  wherein the animal is a human. 
     
     
         20 . The method of claim wherein the composition comprises a pharmaceutically acceptable carrier solution.