title: Retrospective analysis of the results of acellular pertussis vaccine toxicity tests performed in Korea.
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.
authors.affiliation: National Center for Lot Release, National Institute of Food & Drug Safety Evaluation, Korea Food & Drug Administration, Chungcheongbuk, South Korea.
authors.forename: Hokyung
authors.initials: H
authors.lastname: Oh
authors.forename: Jeewon
authors.initials: J
authors.lastname: Joung
authors.forename: Byoungguk
authors.initials: B
authors.lastname: Kim
authors.forename: Halim
authors.initials: H
authors.lastname: Lee
authors.forename: Woosun
authors.initials: W
authors.lastname: Lee
authors.forename: Seung-Hwa
authors.initials: SH
authors.lastname: Hong
authors.forename: Byung-Yoon
authors.initials: BY
authors.lastname: Ahn
mesh_terms: D000818:Animals; D005260:Female; D007723:Korea; D051379:Mice; D010567:Pertussis Vaccine / Q000009:adverse effects*; D012189:Retrospective Studies; D018675:Toxicity Tests / Q000379:methods*; D022282:Vaccines, Acellular / Q000009:adverse effects*
chemical_list: D010567:Pertussis Vaccine; D022282:Vaccines, Acellular