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International assessment of the PSPT in mice to replace the intracerebral-challenge Mouse Protection Test (MPT) for whole-cell Pertussis (wP)

Coordinate an international multi-lab validation study of the Pertussis Serological Potency Test as an alternative to the intracerebral challenge of the Kendrick Test to assess potency of whole-cell Pertussis containing vaccines
Categories
Vaccines
Assays
Project status
100% Completed

Solution

Performance Period: 9/1/2020 to 7/31/2022

Whole-cell Pertussis (wP) containing vaccines are widely used for routine vaccination of children in several parts of the world as part of various combinations of vaccines in childhood immunization programs. The standardization and control of wP containing vaccines was addressed by Kendrick in the 1930s, who developed a mouse protection assay involving intracerebral challenge with a lethal dose of the Bordetella pertussis to assess vaccine potency based on immunized animal survival in the period of two weeks after challenge. This test shows high variability, poor reproducibility, difficulties in statistical validity, requiring use of extensive numbers of animals which experience pain and distress.

This project aims to support in-house validation of a serological assay (Pertussis Serological Potency Test- PSPT) to enable the transition from intracerebral challenge to immunization, to assess the potency of wP containing vaccines in vitro, to reduce variability of the test, the numbers of animals and the level of distress. The PSPT was evaluated in mice and guinea pigs favorably in published studies allowing for discrimination of vaccine batch potency and use of the test for demonstration of consistency in production. Hence, in-house validation of PSPT is now a critical step to enable its implementation globally.

For more project information and a list of participating organizations please visit the project web page on the DCVMN website (link below).

DCVMN – PSPT consortium

Outcomes and Impacts

Enable in-house validation of the Pertussis Serological Potency Testing for assessing potency of whole-cell Pertussis containing vaccines using regional materials

Providing large quantity of Pertussis Serological Potency Testing antigen for future use (up to 10 years)

Updates, Related Publications, and Deliverables

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Project Lead

Developing Countries Vaccine Manufacturers Network

Developing Countries Vaccine Manufacturers Network

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