Polyvalent venom vaccines, methods of use and making

Abstract

This disclosure relates to materials and methods useful for vaccinating mammals against the effects of envenomation by venomous organisms (including the Western Rattlesnake) by making use of venom from multiple distinct populations, subspecies or species of the organism, to make a vaccine more broadly protective against other populations, subspecies or species. This disclosure also relates to a method for determining which organisms which are capable of envenomation should be pooled for optimizing the coverage and efficacy of a vaccine which is produced from the venoms (or toxoid derivatives) in the combination.

1 - 22 . (canceled) 
     
     
         23 . A polyvalent toxoid vaccine comprising a combination of denatured venoms from populations of Western Rattlesnakes selected from the Southern Sierra Nevada Mountains, CA; the Transverse Mountains, CA; and, the San Jacinto Mountains, CA, which is protective against envenomation from Western rattlesnakes and Mojave, Speckled, Western Diamondback, and Red Diamondback rattlesnakes. 
     
     
         24 . The polyvalent toxoid vaccine of  claim 23  wherein the vaccine is prepared as a solution. 
     
     
         25 . The polyvalent toxoid vaccine of  claim 24  wherein the solution has a final concentration of 1 microgram of toxoid per milliliter of solution. 
     
     
         26 . The polyvalent toxoid vaccine of  claim 23  further including one or more members selected from the group consisting of: adjuvants, stabilizers, buffers, salts, preservatives and one or more pharmaceutically acceptable carriers. 
     
     
         27 . The polyvalent toxoid vaccine of  claim 26  wherein the adjuvant is alum. 
     
     
         28 . The polyvalent toxoid vaccine of  claim 26  wherein the preservative is thimerosal. 
     
     
         29 . The polyvalent toxoid vaccine of  claim 23  wherein the venoms are denatured by heating. 
     
     
         30 . The polyvalent toxoid vaccine of  claim 23  wherein the venoms are denatured by irradiation. 
     
     
         31 . A method of immunizing a mammal against envenomation by a rattlesnake comprising administering an effective amount of the polyvalent toxoid vaccine of claim  1  to the mammal. 
     
     
         32 . The method of  claim 31  wherein the rattlesnake is a Western rattlesnake or a Mojave, Speckled, Western Diamondback, or Red Diamondback rattlesnake. 
     
     
         33 . The method of  claim 31  wherein the administration is by intraperitoneal, intravenous, intramuscular or subcutaneous injection. 
     
     
         34 . The method of  claim 31  wherein the mammal is a dog. 
     
     
         35 . The method of  claim 31  wherein the polyvalent toxoid vaccine is administered at a concentration of 1 microgram of toxoid per milliliter of solution. 
     
     
         36 . The method of  claim 31  wherein the formulation is administered at least twice annually. 
     
     
         37 . The method of  claim 36  wherein the formulation is administered at least three times annually. 
     
     
         38 . The method of  claim 37  wherein the second administration is at least 30 days after the first administration. 
     
     
         39 . The method of  claim 31  wherein the dog weighs less than 25 or more than 100 pounds. 
     
     
         40 . A process of making a formulation of a polyvalent toxoid rattlesnake vaccine, comprising denaturing venoms from populations of Western Rattlesnakes selected from the Southern Sierra Nevada Mountains, CA; the Transverse Mountains, CA; and, the San Jacinto Mountains, CA, and combining the denatured venoms in a formulation. 
     
     
         41 . The process of  claim 40  wherein the venoms are denatured by heating or irradiation. 
     
     
         41 . The process of  claim 40  further including adding one or more members selected from the group consisting of adjuvants, stabilizers, buffers, salts, preservatives and one or more pharmaceutically acceptable carriers to the formulation. 
     
     
         42 . The process of  claim 40  wherein the adjuvant added is alum and the preservative added is thimerosal.