US2003064074A1PendingUtilityA1

Recombinant gelatins in vaccines

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Priority: Nov 12, 1999Filed: Aug 30, 2002Published: Apr 3, 2003
Est. expiryNov 12, 2019(expired)· nominal 20-yr term from priority
Inventors:Robert C. ChangKari KivirikkoThomas B. NeffDavid R. OlsenJames Polarek
A61P 31/12A61P 31/04A61P 31/14A61P 31/22A61P 31/20A61P 31/16A61P 19/02A61K 2800/86A61K 9/0014C08H 1/06A23L 29/284A61Q 19/00A61K 47/42A61K 38/00C08L 89/06A61K 8/65G03C 1/047A61K 9/0019C07K 14/78Y02A50/30
50
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Claims

Abstract

The present invention relates to vaccines comprising recombinant gelatin, to methods of producing and using such vaccines, and to vaccination kits.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A vaccine composition comprising: 
 (a) a recombinant gelatin; and    (b) an antigenic agent.    
     
     
         2 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is recombinant human gelatin.  
     
     
         3 . The vaccine composition of  claim 1 , wherein the recombinant gelatin comprises a homogeneous mixture of recombinant gelatin polypeptides.  
     
     
         4 . The vaccine composition of  claim 1 , wherein the recombinant gelatin comprises a heterogeneous mixture of recombinant gelatin polypeptides.  
     
     
         5 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is non- hydroxylated.  
     
     
         6 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is hydroyxlated.  
     
     
         7 . The vaccine composition of  claim 1 , wherein the recombinant gelatin has a percentage hydroxylation selected from the group consisting of 20 to 80%, 30 to 80%, 40 to 80%, 60 to 80%, 80 to 100%, 20 to 60%, 30 to 60%, 40 to 60%, 20 to 30%, 20 to 40%, and 30 to 40%.  
     
     
         8 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is hydrolyzed.  
     
     
         9 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is derived from non-native collagen sequence.  
     
     
         10 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is obtained from one type of collagen free of any other type of collagen.  
     
     
         11 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is proteolytically stable.  
     
     
         12 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is produced by processing of recombinant collagen.  
     
     
         13 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is produced directly from an altered collagen construct.  
     
     
         14 . The vaccine composition of  claim 1 , wherein the recombinant gelatin has a molecular weight range selected from the group consisting of about 0 to 50 kDa, about 10 to 30 kDa, about 30 to 50 kDa, about 10 to 70 kDa, about 50 kDa to 70 kDa about 50 to 100 kDa, about 100 to 150 kDa, about 150 to 200 kDa, about 200 to 250 kDa, about 250 to 300 kDa, and about 300 to 350 kDa.  
     
     
         15 . The vaccine composition of  claim 1 , wherein the recombinant gelatin has a molecular weight selected from the group consisting of about 1 kDa, about 5 kDa, about 8 kDa, about 9 kDa, about 14 kDa, about 16 kDa, about 22 kDa, about 23 kDa, about 44 kDa, and about 65 kDa.  
     
     
         16 . The vaccine composition of  claim 1 , wherein the recombinant gelatin comprises a sequence selected from the group consisting of SEQ ID NOs: 15 through 25, and 30, 31, and 33.  
     
     
         17 . The vaccine composition of  claim 1 , wherein the recombinant gelatin is non-immunogenic.  
     
     
         18 . The vaccine composition of  claim 1 , wherein the recombinant gelatin confers stability at ambient temperatures.  
     
     
         19 . The vaccine composition of  claim 1 , wherein the vaccine composition is suitable for injectable delivery.  
     
     
         20 . The vaccine composition of  claim 1 , wherein the vaccine composition is suitable for nasal delivery.  
     
     
         21 . The vaccine composition of  claim 1 , wherein the vaccine composition is suitable for oral delivery.  
     
     
         22 . The vaccine composition of  claim 1 , wherein the vaccine composition is suitable for transdermal delivery.  
     
     
         23 . The vaccine composition of  claim 1 , wherein the vaccine composition is suitable for mucosal delivery.  
     
     
         24 . The vaccine composition of  claim 1 , wherein the vaccine composition is suitable for deep lung delivery.  
     
     
         25 . The vaccine composition of  claim 1 , wherein the vaccine composition is liquid.  
     
     
         26 . The vaccine composition of  claim 1 , wherein the vaccine composition is dry.  
     
     
         27 . The vaccine composition of  claim 1 , wherein the vaccine composition is lyophilized.  
     
     
         28 . The vaccine composition of  claim 1 , wherein the vaccine composition is powdered.  
     
     
         29 . The vaccine composition of  claim 1 , wherein the vaccine composition is a spray.  
     
     
         30 . The vaccine composition of  claim 1 , wherein the vaccine composition is an inhalant.  
     
     
         31 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises a live vaccine.  
     
     
         32 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises an attenuated vaccine.  
     
     
         33 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises an inactivated vaccine.  
     
     
         34 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises a subunit vaccine.  
     
     
         35 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises a single dosage.  
     
     
         36 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises a multiple dosage.  
     
     
         37 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises a conjugate vaccine.  
     
     
         38 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises a nucleic acid vaccine.  
     
     
         39 . The vaccine composition of  claim 38 , wherein the nucleic acid vaccine is a DNA vaccine.  
     
     
         40 . The vaccine composition of  claim 1 , wherein the vaccine composition is a combined vaccine.  
     
     
         41 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises an acellular vaccine.  
     
     
         42 . The vaccine composition of  claim 1 , wherein the vaccine composition comprises a vaccine formulated for the prevention of a disease selected from the group consisting of vacinnia virus (small pox), polio virus (Salk and Sabin), mumps, measles, rubella, diphtheria, tetanus, Varicella-Zoster (chicken pox/shingles), pertussis (whopping cough), Bacille Calmette-Guerin (BCG, tuberculosis), haemophilus influenzae meningitis, rabies, cholera, Japanese encephalitis virus, salmonella typhi, shigella, hepatitis A, hepatitis B, adenovirus, yellow fever, foot-and-mouth disease, herpes simplex virus, respiratory syncytial virus, rotavirus, Dengue, West Nile virus, Turkey herpes virus (Marek's Disease), influenza, and anthrax.  
     
     
         43 . The vaccine composition of  claim 1 , wherein the recombinant gelatin has an endotoxin level of below 1.000 EU/mg.  
     
     
         44 . The vaccine composition of  claim 1 , wherein the recombinant gelatin has an endotoxin level of below 0.500 EU/mg.  
     
     
         45 . The vaccine composition of  claim 1 , wherein the recombinant gelatin has an endotoxin level of below 0.050 EU/mg.  
     
     
         46 . The vaccine composition of  claim 1 , wherein the recombinant gelatin has an endotoxin level of below 0.005 EU/mg.  
     
     
         47 . A method of producing a vaccine composition comprising recombinant gelatin, the method comprising: 
 (a) providing an antigenic agent;    (b) providing a recombinant gelatin; and    (c) combining the antigenic agent and the recombinant gelatin.    
     
     
         48 . A vaccine stabilizer comprising a recombinant gelatin.  
     
     
         49 . A vaccine stabilizer comprising a recombinant human gelatin.  
     
     
         50 . A method of inducing an immune response in a subject, the method comprising administering the vaccine composition of  claim 1  to the subject.  
     
     
         51 . A method of stabilizing a vaccine composition, the method comprising adding the vaccine stabilizer of  claim 48  to a vaccine composition.  
     
     
         52 . A vaccination kit, the kit comprising: 
 (a) a vaccine comprising recombinant gelatin; and    (b) a delivery device for delivery of the vaccine.

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