Background: Despite the adoption and introduction of acellular pertussis (aP) vaccines in an increased number of countries, whole cell Pertussis (wP) based vaccines will continue to be produced and used globally, particularly in developing countries for the future decades.
The standardization and control of wP vaccines was addressed by Kendrick & Eldering in the 1930s, and evidence was shown that protection in mice against intracerebral challenge correlated to protection in immunized children against whooping cough. This was the basis for the establishment of the the intracerebral Mouse Protection Test (MPT) as the authoritative potency assay for batch release.
However, the intracerebral challenge MPT shows high variability, poor reproducibility, difficulties in meeting the statistical validity criteria of the assay and thus requires use of extensive numbers of animals which experience severe pain and distress in the procedure.
DCVMN, with the scientific advice of ISSI and INTRAVACC, proposes to support an “in house validation consortium of the new serological assay“, to transition away from the in vivo intracerebral challenge test to assess the potency of wP vaccines, and reduce both variability of the test and lead time for batch release.
Ten laboratories will be invited to participate in the study, to be run over the next 12 months, and qualified coating antigen for the ELISA plates will be provided for free by DCVMN. Participating laboratories will be expected to attend at least three of four Partners meetings, to be held in the US, in Italy and in India. DCVMN may be able to cover for travel and lodging costs.
» Download the PSPT Concept paper
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