Vaccine stabilizer

• US 4,147,772 A
• Filed: 02/23/1978
• Issued: 04/03/1979
• Est. Priority Date: 02/03/1976
• Status: Expired due to Term

• Current Assignee: Merck & Co., Inc.
• Original Assignee: Merck & Co., Inc.
• Inventors: Markus, Henry Z., McAleer, William J.
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US05/880,667
• Time in Patent Office: 404 Days
• Field of Search: 424/89, 195/1.1-1.8
• US Class Current: 424/202.1
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/165 Mumps or measles virus
• CPC Class Codes: C12N 2760/18434 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/18451 Methods of production or purification of viral material
• CPC Class Codes: C12N 7/00 Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00
• 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

A stabilized lyophlized or liquid live viral vaccine contains a live virus, partially hydrolyzed gelatin, a 6-carbon polyhydric alcohol, Medium 199 and acidic buffer.

Claims

1. A vaccine comprising an inactivated or attenuated virus and a stabilizer consisting essentially of on a parts by weight basis from about 2 to about 5 parts partially hydrolyzed gelatin having a molecular weight of about 3,000, from about 2 to about 55 parts of sorbitol, mannitol or dulcitol, from about 0.5 to about 1.7 parts of Medium 199 or equivalent cell culture medium and an amount of a physiologically acceptable acidic buffer effective to adjust the pH to from about 6.0 to about 6.5.

2. A vaccine according to claim 1 wherein the 6-carbon polyhydric alcohol is sorbitol.

3. A vaccine according to claim 1 wherein the buffer is phosphate buffer.

4. A vaccine according to claim 1 wherein the virus is measles, mumps, rubella, varicella, polio or hepatitis, herpes simplex 1, herpes simplex 2, or combinations thereof.

5. A vaccine according to claim 1 wherein the stabilizer consists essentially of on a parts by weight basis about 3.6 parts of partially hydrolyzed gelatin, about 3.6 parts of sorbitol, about 1.1 parts of Medium 199 and an amount of phosphate buffer effective to adjust the pH to from about 6.0 to about 6.5.

6. A vaccine according to claim 1 wherein the stabilizer consists essentially on a parts by weight basis about 3.6 parts of partially hydrolyzed gelatin, about 53 parts of sorbitol, about 1.1 parts of Medium 199 and an amount of phosphate buffer effective to adjust the pH to from about 6.0 to about 6.5.

7. A stabilized vaccine obtained by reconstituting a lyophilized vaccine containing a stabilizer according to claim 1.

8. A stabilized vaccine obtained by thawing a frozen vaccine containing a stabilizer according to claim 1.

9. A vaccine according to claim 1 containing from about 2 to about 12 volumes of stabilizer to about one volume of vaccine.

10. A method for stabilizing a vaccine comprising adding to the vaccine an amount of stabilizer according to claim 1 effective to stabilize the vaccine.