Abstract

LANDYS CHOVEL, Mario; FIGUEROA, Juan Miguel  and  PERDOMO, Vicente. Limitations of specific toxicity assay for whole-cell pertussis component. Vaccimonitor [online]. 2008, vol.17, n.3, pp.6-12. ISSN 1025-028X.

Vaccines containing whole-cell Pertussis component have been used with a high effectiveness in National Immunisation Programs worldwide. Despite of their efficacy, concerns remained in regard to reactogenicity due to the presence of components like Pertussis toxin and endotoxins. During decades the specific toxicity of Pertussis component has been monitored by the Mouse Weight Gain Test, but the test has been criticised in terms of lack of specificity and sensitivity and great variability. That is why the National Control Laboratory decided to evaluate its relevance for the release of DPT vaccine lots. We evaluated different concentrations of endotoxins and pertussis toxin as well as the variability among assays. The results showed that only very high concentrations of endotoxin and pertussis toxin were able to produce a reduction of the weight gain in mice and a specification failure of the assay. This aspect and the great variability found were determinant to decide not to use this test for the release of DPT vaccine lots and to remain looking for new alternatives.

Keywords : Whole-cell Pertussis; Mouse Weight Gain Test; Limitations of the method.

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