Home > PSPT consortium

PSPT Consortium

International In-house validation 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 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 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, in-house validation 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.

Members

MemberType of LaboratoryLocationwP-containing
Products Released
Batch Release Methods
Biofarma Indonesia
Biological E India
Panacea Biotec India
Bharat Biotech India
Serum Institute of India India
Sanofi Healthcare India Pvt. Ltd India
Pasteur Institute of India India
Central Drugs Laboratory, Kasauli, INDIA India
BulBio Bulgaria
Central Laboratory Thailand Thailand

Key documents

PSPT Consortium Steering Group (PDF)

Partners: