Retrospective analysis of the results of acellular pertussis vaccine toxicity tests performed in Korea

Hokyung Oh, Jeewon Joung, Byoungguk Kim, Halim Lee, Woosun Lee, Seung Hwa Hong, Byung Yoon Ahn

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Specific toxicity test is a major quality control test for acellular pertussis (aP) vaccines performed by manufacturers and regulatory authorities. The 'mouse body weight gain test (MWGT)', the 'leukocytosis-promoting test (LPT)' and the 'histamine sensitization test (HIST)' have been conducted to check the specific toxicity of all batches of aP vaccines used in Korea through the national quality control program, which requires a lot of animals, labor and time. In this study, test results obtained in the past 9 y from a total of 258 lots of aP vaccines were examined retrospectively to evaluate the three test methods. A pairwise comparison of the test results indicated a good correlation between LPT and HIST, whereas MWGT showed no correlation with either LPT or HIST. Moreover, the reversion to toxicity was higher than the residual toxicity in the majority of lots tested by HIST, which indicated that the histamine-sensitizing toxicity, although rated within a safe range, increased during the vaccine storage. Thus, the vaccine safety test results accumulated in the past might be useful for the improvement of test protocols.

Original languageEnglish
Pages (from-to)783-787
Number of pages5
JournalHuman Vaccines and Immunotherapeutics
Volume8
Issue number6
DOIs
Publication statusPublished - 2012 Jun

Keywords

  • Acellular pertussis vaccine
  • Histamine sensitization test
  • Leukocytosis-promoting test
  • Mouse body weight gain test
  • Specific toxicity test

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

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