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Refrigerator-temperature stable influenza vaccine compositions

a technology of influenza vaccine and composition, which is applied in the direction of drug composition, antibody medical ingredients, immunocompromised persons, etc., can solve the problems of delayed and shortage of production and distribution, special risk of death for immunocompromised persons, and elderly people without adequate health car

Inactive Publication Date: 2006-05-25
MEDIMMUNE LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008] The current invention provides liquid vaccine formulations that are substantially stable at temperatures ranging from 4° C. to 8° C. These and other liquid formulations, which are specific embodiments of the invention are referred to herein, for example, as “vaccine formulations

Problems solved by technology

Infants, the elderly, those without adequate health care and immunocompromised persons are at special risk of death from such infections.
Because the supply of eggs must be organized, and strains for vaccine production selected months in advance of the next flu season, the flexibility of this approach can be limited, and often results in delays and shortages in production and distribution.

Method used

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  • Refrigerator-temperature stable influenza vaccine compositions
  • Refrigerator-temperature stable influenza vaccine compositions
  • Refrigerator-temperature stable influenza vaccine compositions

Examples

Experimental program
Comparison scheme
Effect test

example 1

Development of Liquid FluMist

[0166] A total of 19 monovalent bulk lots of virus were initiated under protocol, including four development lots (CB0006H, CB0008H, CG0017H, CB0018H and CB0019H). Lots CB0018H and CB0019H were conducted to supply material for various studies and are not discussed further in this application. Two lots (CB00180H and CB0012H) were combined after the ultra-centrifugation step to produce A / Sydney monovalent bulk CB0020H. Each lot was initiated with about 2000 eggs.

[0167] Egg handling and incubation conditions were set up similar to the process used for production of frozen FluMist, however, manual inoculation and harvesting were used due to the smaller scale, etc. The ultracentrifuge process was scaled down to smaller equipment made by the same manufacturer (Discovery 90, made by Hitachi and marketed by Sorvall / heraus), with a Model P32CT rotor having approximately 470 mL of total capacity. Clarified, stabilized virus harvest was loaded onto a 20% to 60% ...

example 2

Stability Testing

[0233] A trivalent vaccine formulation was prepared comprising three different reassortant influenza viruses (7.0+ / −0.5 log10 FFU / dose [approximately 7.0+ / −0.5 log10TCID50 / dose]) and comprising 200 mM sucrose; 1% (w / v) porcine gelatin hydrolysate; 1.21% (w / v) arginine monohydrocloride [equivalent to 1% (w / v) arginine base]; and 5 mM monosodium glutamate in 100 mM potassium phosphate buffer (pH 7.2). The stability of the formulation was stored at −25.0 degrees C+ / −5.0 degrees for greater than or equal to 24 hours, but less than or equal to two weeks and then stored at 2-8 degrees C. for various time periods. This formulation (e.g., lot 0141500003) was determined to be stable for at least 12 weeks at 4-8 degree C. In particular, the potency for each strain of virus remained within 0.5 log10 of the beginning potency prior to 4-8 degree C. storage.

[0234] Other studies have shown that equivalent formulations (comprising three different reassortant influenza viruses (7....

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Abstract

Methods and compositions for the optimization and production of refrigerator-temperature stable virus, e.g., influenza, compositions are provided. Formulations and immunogenic compositions comprising refrigerator-temperature stable virus compositions are provided.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit under 35 U.S.C § 119(e) of U.S. Provisional Application No. 60 / 616,711, filed on Oct. 6, 2004; and is a continuation-in-part of and claims the benefit under 35 U.S.C. § 120 of U.S. patent application Ser. No. 10 / 788,236, filed Feb. 25, 2004, which claims the benefit under 35 U.S.C § 119(e) of U.S. Provisional Application No. 60 / 450,181, filed Feb. 25, 2003. All of the foregoing applications are incorporated herein by reference in their entirety.BACKGROUND OF THE INVENTION [0002] Vaccines against various and evolving strains of influenza are important not only from a community health stand point, but also commercially, since each year numerous individuals are infected with different strains and types of influenza virus. Infants, the elderly, those without adequate health care and immunocompromised persons are at special risk of death from such infections. Compounding the problem of influenza infections...

Claims

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Application Information

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IPC IPC(8): A61K39/145C12N7/00
CPCA61K39/12A61K39/145C12N7/00A61K2039/70C12N2760/16151C12N2760/16234C12N2760/16251C12N2760/16134A61P31/16A61P37/04
Inventor KEMBLE, GEORGETRAGER, GEORGESCHWARTZ, RICHARD
Owner MEDIMMUNE LLC
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