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PSPT Consortium

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

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 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 Mouse Protection Test (MPT) or Kendrick Test shows high variability, requiring use of extensive numbers of animals which experience severe pain and distress. This project aims to support in-house assessment 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 with an ELISA, to reduce variability of the test, the numbers of animals and the level of distress. The PSPT was evaluated in mice and guinea pigs favourably in published studies allowing for discrimination of vaccine batch potency and use of the test for demonstration of consistency in production. Hence, the assessment of PSPT is now a critical step.
An ad hoc Steering Group will guide the Consortium on all the scientific and technical aspects of the project.

Project Final Meeting

Presentations (click on the name of the presentation to download it)
1. PSPT Project Scope and Participants
2. PSPT Project Outcomes
3. BioLyo Coating Antigen Production
4. Intravacc Coating antigen characterization
5. PSPT Study design, Protocols and setting
6. PSPT Statistical Analysis
7. PSPT Challenges and proposed solutions
8. Mantis_Antibody-based methodology to assess the stability of wP vaccines