Extracellular matrix materials as vaccine adjuvants for diseases associated with infectious pathogens or toxins

• US 9,308,252 B2
• Filed: 01/30/2007
• Issued: 04/12/2016
• Est. Priority Date: 10/27/2005
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated), University of Notre DAME Du Lac
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated), University of Notre DAME Du Lac
• Inventors: Suckow, Mark A., Wolter, William R., Hall, Paul
• Primary Examiner(s): Horning, Michelle S
• Application Number:
  US11/699,448
• Publication Number:
  US 20080107665A1
• Time in Patent Office: 3,360 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/55511 Organic adjuvants
• CPC Class Codes: A61K 2039/55588 Adjuvants of undefined constitution
• CPC Class Codes: A61K 39/08 Clostridium, e.g. Clostridium tetani
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 39/02 Antidotes
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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 immunogencity of an infectious pathogen antigen or biological toxin antigen of interest, as well as to enhance the survival of an immunized animal.

Claims

1. A composition suitable for use against an infectious pathogen comprising:

an immunogenic amount of an infectious pathogen or biological toxin antigen preparation of interest; and

an adjuvant of heterologous extracellular matrix, wherein the immunogenic amount of the infectious pathogen or biological toxin antigen preparation of interest in the presence of the adjuvant is less than the immunogenic amount of the infectious pathogen or biological toxin antigen preparation of interest that elicits a detectable protective response in the absence of the adjuvant, wherein the infectious pathogen antigen preparation of interest comprises an inactivated preparation of the infectious pathogen antigen of interest or toxic products thereof.

2. The adjuvant of claim 1, wherein said infectious pathogen or biological toxin is tetanus, influenza, rabies, viral hepatitis, diphtheria, anthrax, Streptococcus pneumoniae infection, malaria, leishmaniasis, ricin toxicosis, prions, or Staphylococcal enterotoxin B toxicois.

3. The composition of claim 1, wherein the infectious pathogen or-biological toxin antigen preparation of interest is tetanus toxoid.

4. The composition of claim 1, wherein the extracellular matrix is a heterologous acellular collagenous tissue preparation.

5. The composition of claim 1, prepared by a method comprising:

obtaining an adjuvant of an extracellular matrix capable of enhancing the immunogenicity of an infectious pathogen or biological toxin antigen of interest; and

combining said adjuvant with an immunogenic amount of an infectious pathogen or biological toxin antigen of interest.

6. The composition of claim 1, wherein the infectious pathogen is tetanus.

7. The composition of claim 1, wherein the extracellular matrix comprises a heterologous acellular collagenous tissue preparation.

8. The composition of claim 1, wherein the biological toxin antigen preparation of interest comprises an inactivated preparation of the biological toxin antigen of interest.

9. The composition of claim 1, wherein the extracellular matrix consists essentially of a heterologous acellular collagenous tissue preparation.

10. The composition of claim 9, wherein the adjuvant comprises a 1:

10 ratio of the extracellular matrix and a pharmaceutically acceptable carrier solution.

11. The composition of claim 1, wherein the immunogenic amount of the biological toxin antigen preparation of interest is 0.03 μ

g to 0.05 μ

g of a tetanus toxoid.

12. The composition of claim 1 comprising a vaccine.

13. A method for immunizing an animal against an infectious pathogen of interest comprising:

administering an immunogenic amount of the composition of claim 1 composition comprising an infectious pathogen antigen of interest and an infectious pathogen vaccine adjuvant sufficient to stimulate an immune response in said animal for said infectious pathogen of interest or a toxic product produced by said infectious pathogen of interest, wherein the immunogenic amount of the composition sufficient to stimulate an immune response in the animal is less than the immunogenic amount of the infectious pathogen antigen of interest in the absence of the infectious pathogen vaccine adjuvant sufficient to stimulate an immune response.

14. The method of claim 13 wherein the infectious pathogen antigen of interest comprises a tetanus toxoid preparation.

15. The method of claim 13 wherein the immunogenic amount of the composition comprises 0.03 μ

g to 0.05 μ

g of the tetanus toxoid.

16. The method of claim 13 wherein an immunized animal has an enhanced survival rate compared to a non-immunized animal.