Pertussis Serological Potency Test as an Alternative to the Intracerebral Mouse Protection Test: Development, Evaluation and Validation.

We have developed the Pertussis Serological Potency Test (PSPT) as an alternative to potency testing of pertussis Whole Cell Vaccines (WCV) in the intracerebral Mouse Protection Test (MPT). The PSPT is based on the humoral antibody response against the whole range of B. pertussis surface-antigens per vaccine dose and correlates well with the MPT. WCV-induced-antibody responses against "protective" antigens; or the biological activitv of pertussis antibodies poorly correlated or did not correlate at all with mouse protection. Compared to the MPT the PSPT is more reproducible, reduces the animal distress and the number of animals in use. Moreover, the number of animals in use could be reduced even more by simplifying the multiple dose design to a single dose model and by combining in vitro assays for potency testing of tetanus, diphtheria and pertussis components in one animal model