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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

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)

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