Claims for Patent: 4,000,256

Summary for Patent: 4,000,256

Title:	Varicella vaccine and process for its preparation
Abstract:	Preparation of safe, live, attenuated varicella virus vaccine by serial propagation of varicella virus in tissue cell culture systems.
Inventor(s):	Hilleman; Maurice R. (Lafayette Hill, PA), Buynak; Eugene B. (North Wales, PA), Neff; Beverly J. (Harleysville, PA)
Assignee:	Merck & Co., Inc. (Rahway, NJ)
Application Number:	05/592,562
Patent Claims:	1. A process for the preparation of a live attenuated, cell-free varicella virus useful as an antigen in a vaccine, which will evoke in man an antibody response against a virulent varicella virus without causing the severe clinical manifestations of the disease which comprises serially passaging the virulent virus from about 10 to about 80 times at 30.degree.-38.degree. C. in a tissue culture preparation selected from the group consisting of human and animal diploid cell strains and primary cells of simian origin to attenuate the virus followed by release of the attenuated virus from the infected cell by sonication in the presence of a stabilizer comprising sucrose, albumin, glutamine and phosphate. 2. The process of claim 1 wherein the serial passaging is at 32.degree. C. 3. The process of claim 1 wherein the serial passaging is at 32.degree. C. and 36.degree. C. 4. The process of claim 1 wherein the tissue culture preparation is of human diploid cell strains. 5. The process of claim 4 wherein the human diploid cell strain is human fetal lung tissue. 6. The process of claim 5 wherein the human fetal lung tissue is WI-38. 7. The process of claim 1 wherein the tissue culture preparation is of primary cells of simian origin. 8. The process of claim 7 wherein the primary cells of simian origin are of monkey testicular tissue. 9. The process of claim 1 wherein the tissue culture preparation is of animal diploid cell strain. 10. The process of claim 9 wherein the animal diploid cell strain is of fetal rhesus tissue. 11. The process of claim 6 wherein the stabilizer is SPGA. 12. A live, attenuated cell-free varicella vaccine comprising an immunologically effective amount of a live attenuated cell-free varicella virus prepared by the process of serially passaging the virulent virus from about 10 to about 80 times at 30.degree.-38.degree. C. in a tissue culture preparation selected from the group consisting of human and animal diploid cell strains and primary cells of simian origin to attenuate the virus followed by release of the attenuated virus from the infected cell by sonication in the presence of a stabilizer comprising sucrose, albumin, glutamine and phosphate in combination with a carrier comprising sterile water. 13. The vaccine of claim 10 wherein the serial passaging is at 32.degree. C. and 36.degree. C. 14. The vaccine of claim 12 wherein the tissue culture preparation is of human diploid cell strains. 15. The vaccine of claim 14 wherein the human diploid cell strain is human fetal lung tissue. 16. The vaccine of claim 15 wherein the human fetal lung tissue is WI-38. 17. The vaccine of claim 16 wherein the stabilizer is SPGA. 18. The varicella vaccine of claim 12 is wet-frozen form. 19. The varicella vaccine of claim 12 in lyophilized form. 20. A method of providing immunity against varicella which comprises the administration of the varicella vaccine of claim 12.

Details for Patent 4,000,256

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		1993-12-28