US2015157703A1PendingUtilityA1

Method of rapidly producing improved vaccines for animals

Assignee: HARRISVACCINES INCPriority: Oct 27, 2010Filed: Feb 17, 2015Published: Jun 11, 2015
Est. expiryOct 27, 2030(~4.3 yrs left)· nominal 20-yr term from priority
C12N 2770/32122A61K 39/12C12N 2770/10022C12N 2320/32C12N 2770/32134C12N 2720/00034C12N 2770/10034C12N 7/00A61K 39/135C12N 2720/12143A61K 2039/552A61P 37/04C12N 2710/18034C12N 2310/111C12N 2720/00022C12N 15/111C07K 14/005A61K 39/145A61K 2039/53C12Q 1/701A61P 31/00C12N 2760/16134C12N 2310/14C12N 2770/36143C12N 2760/16034C12N 2760/16122C12N 15/1131C12N 15/86C12N 2710/18022A61K 39/0013
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Claims

Abstract

A method of quickly producing a vaccine for a biotype of pathogenic microorganism is described, where a nucleic acid molecule or fragment thereof is obtained from a biological sample from an animal exposed to the microorganism, a protective molecule is prepared based on the nucleic acid molecule of interest or fragment thereof, and administered to an animal which has been or is as risk of being exposed to the microorganism. A protective response to the biotype of the microorganism is obtained in the animal.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of producing an autogenous vaccine to protect a second animal from a biotype of a microorganism, the method comprising,
 a) selecting a nucleic acid molecule of interest or fragment thereof (NOI) of said microorganism, said NOI known to be capable of producing a protective response in the same species as the second animal;   b) obtaining a biological sample from at least one first animal where said first animal has been exposed to said biotype of said microorganism;   c) obtaining from said sample said NOI of said microorganism without the need to isolate said microorganism;   d) producing a protective molecule from said NOI, said protective molecule selected from the group consisting of:
 (i) a polypeptide or fragment thereof expressed by said NOI; and 
 (ii) an RNA particle comprising or producing (i); 
   e) producing a vaccine comprising said protective molecule, wherein said protective molecule does not comprise said microorganism or a replicable or living pathogenic microorganism; and   f) providing said protective molecule in said vaccine in an amount that when administered to said second animal protects said second animal from said biotype of said microorganism.   
     
     
         2 . The method of  claim 1 , wherein said vaccine is capable of being produced in three months or less from the time of obtaining said NOI. 
     
     
         3 . The method of  claim 1 , wherein said vaccine is capable of being produced in two months or less from the time of obtaining said NOI. 
     
     
         4 . The method of  claim 1 , wherein said vaccine is capable of being produced in one month or less from the time of obtaining said NOI. 
     
     
         5 . The method of  claim 1 , wherein said vaccine is capable of being produced in seven days or less from the time of obtaining said NOI. 
     
     
         6 . The method of  claim 1 , wherein said microorganism biotype is determined by comparing said NOI nucleic acid molecule or fragment thereof, or polypeptide expressed by said nucleic acid molecule or fragment thereof with at least one known nucleic acid molecule or at least one known polypeptide. 
     
     
         7 . The method of  claim 1 , further comprising introducing an alphavirus replicon vector comprising said NOI into a host cell, expressing a polypeptide or fragment thereof from said NOI, and extracting said polypeptide or fragment from said host, wherein said extracted polypeptide or fragment thereof comprises said protective molecule. 
     
     
         8 . The method of  claim 7 , wherein said vector comprises a Venezuelan Equine Encephalitis (VEE) vector, said host comprises Vero cells and said polypeptide or fragment thereof is extracted by lysing said Vero cells. 
     
     
         9 . The method of  claim 1 , wherein said protective molecule comprises an RNA particle, and said RNA particle comprises said NOI or a fragment thereof. 
     
     
         10 . The method of  claim 1 , wherein said RNA particle comprises an alphavirus replicon vector. 
     
     
         11 . The method of  claim 1 , wherein said vaccine further comprises an adjuvant. 
     
     
         12 . The method of  claim 1 , further comprising determining the amount of protective molecule by determining the amount of RNA Particle (RP) titer and providing said protective molecule at a RP titer that when administered protects said animal. 
     
     
         13 . The method of  claim 1 , further comprising obtaining biological samples over a period of time, obtaining a NOI from said samples and comparing a later obtained NOI with an earlier obtained NOI and producing said vaccine when said later obtained NOI is different from said earlier obtained NOI. 
     
     
         14 . The method of  claim 1 , wherein said at least one first animal is in a first plurality of animals exposed to a first microorganism for which a first protective molecule is produced, which first plurality of animals has or will have sufficient exposure to at least one animal or biological sample of a second plurality of animals exposed to a second microorganism, such that said first and second plurality of animals are at risk of exposure to microorganisms present in the other plurality of animals, said method further comprising,
 a) obtaining a biological sample from at least one animal in said second plurality of animals;   b) producing a second protective molecule from a NOI obtained from said biological sample of at least one animal of said second plurality of without the need to isolate said second microorganism; and   c) providing said second protective molecule in said vaccine in an amount that when administered to said second animal protects said second animal from said biotype of said second microorganism.   
     
     
         15 . The method of  claim 1 , wherein said animal is selected from the group consisting of swine, cattle, canines, felines, equines and aquatic invertebrates. 
     
     
         16 . A method of protecting a second animal from a biotype of a microorganism, the method comprising,
 a) identifying a nucleic acid molecule of interest or fragment thereof (NOI) of a microorganism, said NOI capable of producing a protective response in the same species as the second animal;   b) obtaining a biological sample from at least one first animal where said first animal has been exposed to said biotype of said microorganism;   c) obtaining from said sample said NOI of said microorganism without the need to isolate said microorganism;   d) producing a protective molecule from said NOI, said protective molecule, selected from the group consisting of:
 (i) a polypeptide or fragment thereof expressed by said NOI; and 
 (ii) a RNA particle comprising or producing (i); 
   e) producing a vaccine comprising said protective molecule, wherein said protective molecule does not comprise said microorganism or a replicable or living pathogenic microorganism;   f) providing said protective molecule in an amount that when administered to said second animal protects said second animal from said biotype of said microorganism;   g) administering said protective molecule to at least one said second animal; and   h) producing a protective response specific to said biotype of said microorganism in said second animal.   
     
     
         17 . The method of  claim 16 , further comprising administering said protective molecule to said second animal wherein (i) said second and said first animal are the same; (ii) said second animal is living with said first animal or (iii) said second animal is an animal having or which will have sufficient exposure to said first animal or a biological sample of said animal of (i) or (ii) so as to be at risk of exposure to said biotype of said microorganism. 
     
     
         18 . The method of  claim 16 , further comprising administering said vaccine to a plurality of animals in the same herd as said first animal. 
     
     
         19 . The method of  claim 16 , wherein said second animal is at or will be at the same farm as said first animal. 
     
     
         20 . The method of  claim 16 , wherein said animal from which said biological sample is obtained is an animal in a first plurality of animals exposed to a first microorganism for which a first protective molecule is produced, which first plurality of animals has or will have sufficient exposure to at least one animal or biological sample of a second plurality of animals exposed to a second microorganism, such that said first and second plurality of animals are at risk of exposure to microorganisms present in the other plurality of animals, said method further comprising,
 a) obtaining a biological sample from at least one animal in said second plurality of animals;   b) producing a second protective molecule from a NOI obtained from said biological sample of said at least one animal of said second plurality of without the need to isolate said second microorganism;   c) providing said second protective molecule in an amount that when administered to an animal protects said animal from the biotype of said second microorganism; and   d) administering said first and second protective molecules to said first and second plurality of animals.

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