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 alter native to potency testing of pertussis Whole Cell Vaccines (WCV) in the int racerebral Mouse Protection Test (MPT). The PSPT is based on the humoral an tibody response against the whole range of B. pertussis surface-antigens pe r vaccine dose and correlates well with the MPT WCV-induced-antibody respon ses against "protective" antigens; or the biological activitv of pertussis antibodies poorly correlated or did not correlate at all with mouse protect ion. 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 t o a single dose model and by combining in vitro assays for potency testing of tetanus, diphtheria and pertussis components in one animal model.