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Development of a Hepatitis B Virus Reporter System to Monitor the Early Stages of the Replication Cycle
Published on: February 1, 2017
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METHODS FOR ASSESSMENT OF THE SPECIFIC ACTIVITY OF DRUGS FOR PREVENTION OF HEPATITIS B.
E L Postnova1, N V Shalunova1, K A Sarkisyan1
1Scientific Centre for Expert Evaluation of Medicinal Products.
Voprosy Virusologii
|December 10, 2022
Summary
This study validates enzyme immunoassay (ELISA) for assessing hepatitis B vaccine quality, confirming high immunogenicity of Russian vaccines. The findings support reducing animal testing in favor of reliable in vitro methods for vaccine quality control.
Area of Science:
- Immunology
- Vaccinology
- Laboratory Medicine
Background:
- Immunologic activity is a key quality indicator for hepatitis B vaccines, alongside safety.
- Assessing vaccine quality involves evaluating specific activity through laboratory methods.
Purpose of the Study:
- To conduct a retrospective analysis of laboratory methods for assessing the specific (immunogenic) activity of modern hepatitis B vaccines.
- To evaluate the efficacy and standardization of in vitro (HBsAg content) and in vivo (immunogenicity in mice) methods.
Main Methods:
- Retrospective analysis of laboratory control data for over 170 vaccine series from 2013-2015.
- Utilized enzyme-linked immunosorbent assay (ELISA) for HBsAg content determination.
- Employed a biological method for immunogenicity evaluation based on ED50 analysis in mice.
Main Results:
- Confirmed the efficiency and expediency of ELISA for determining HBsAg content in hepatitis B vaccines.
- Validated the use of Murex HBsAg Version 3 test systems for ELISA testing.
- Demonstrated persistently high immunogenic activity in Russian commercial hepatitis B vaccines through biological testing.
Conclusions:
- Enzyme immunoassay is a reliable and efficient method for assessing hepatitis B vaccine quality.
- The comparability of ELISA and in vivo methods supports reducing animal testing.
- These findings underscore the quality of Russian-produced hepatitis B vaccines.
Keywords:
ELISAHBsAghepatitis B vaccinespecific activitysurface antigen of a virus of hepatitis Bviral hepatitis BMore Related Videos
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