Freeze-dried hepatitis A attenuated live vaccine and its stabilizer
First Claim
1. A stabilized lyophilized hepatitis A live vaccine formulation comprising prophylactically effective titers of live attenuated hepatitis A virus and a stabilizer, wherein said live attenuated hepatitis A virus is prepared from the wild-type HAV, strain L-A-I, and wherein said stabilizer is present in the vaccine formulation at a concentration sufficient to stabilize the hepatitis A virus against heat inactivation.
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Abstract
The present invention relates to hepatitis A vaccine, especially to a lyophilized attenuated hepatitis A vaccine which can be stored at ambient temperature for extended periods of time, and to a method for producing the same. The present invention further relates to a stabilizer for lyophilized live vaccine and its use in improving thermostability of lyophilized live vaccine during lyophilization processing and storage period after lyophilization.
26 Citations
10 Claims
- 1. A stabilized lyophilized hepatitis A live vaccine formulation comprising prophylactically effective titers of live attenuated hepatitis A virus and a stabilizer, wherein said live attenuated hepatitis A virus is prepared from the wild-type HAV, strain L-A-I, and wherein said stabilizer is present in the vaccine formulation at a concentration sufficient to stabilize the hepatitis A virus against heat inactivation.
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8. A stabilizer for lyophilized live virus, wherein said stabilizer comprises gelatin;
- trehalose;
at least one amino acid selected from the group consisting of glutamic acid, aspartic acid, arginine, lysine, and alkali metal salts of any of the foregoing, ascorbic acid;
urea;
mannitol or sorbitol or both of them; and
inositol. - View Dependent Claims (9, 10)
- trehalose;
Specification