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

Member	Type of Laboratory	Location	wP-containing Products Released	Batch Release Methods
Bharat Biotech	Vaccine Manufacturer	India	DTP DTPHib DTPHepBHib	Kendrick Test or Mouse Protection Test
Biofarma	Vaccine Manufacturer	Indonesia	DTP DTPHepBHib Monovalent whole cell pertussis bulk	Kendrick Test or Mouse Protection Test
Biological E	Vaccine Manufacturer	India	DTPHepBHib	Kendrick Test or Mouse Protection Test
Panacea Biotec	Vaccine Manufacturer	India	DTPHib DTPHepBHib DTPHepBHibIPV	Kendrick Test or Mouse Protection Test
BulBio	Vaccine Manufacturer	Bulgaria	DTP	Kendrick Test or Mouse Protection Test
Central Drugs Laboratory, Kasauli, INDIA	National Control Laboratory	India	DTP DTPHepB DTPHib DTPHepBHib DTPHepBHibIPV	Kendrick Test or Mouse Protection Test
Intravacc	Research institute	The Netherland	NA	NA
National Institute of Public Health National Institute of Hygiene	Research institute National control laboratory	Poland	DTP	Kendrick Test or Mouse Protection Test
Serum Institute of India	Vaccine Manufacturer	India	DTwPHepBHib DTwP Hexavalent vaccine under development	Kendrick Test or Mouse Protection Test
Sanofi Healthcare India Pvt. Ltd	Vaccine Manufacturer	India	DTPHepBHib	Kendrick Test or Mouse Protection Test
Pasteur Institute of India	Vaccine Manufacturer Research institute	India	DTP	Kendrick Test or Mouse Protection Test
Central Laboratory Thailand	National Control Laboratory	Thailand	DTP DTPHB DTPHBHib DTPIPVHB	Kendrick Test or Mouse Protection Test

Key documents

PSPT Consortium Steering Group (PDF)