Comparative analysis of the intracerebral mouse protection test and serological method for potency assays of pertussis component in DTP vaccine

Matos, Denise C. S.; Marcovistz, Rugimar; Silva, Andréa Marques Vieira da; Quintilio, Wagner; Georgini, Ricardo Amaral

doi:10.1590/s1517-83822012000200001

Cited by 3 publications

(2 citation statements)

References 7 publications

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“…Serological potency tests for wP vaccines in mice and guinea pigs have been reported in a number of publications [89][90][91][92][93]. Such assays have the potential to reduce the overall severity of animal procedures used in assessing the potency of wP vaccines, but, at the moment, there remain a number of unresolved issues.…”

Section: Serological Potency Assaymentioning

confidence: 99%

Whole-cell pertussis vaccine potency assays: the Kendrick test and alternative assays

Xing

Markey

Das

et al. 2014

Expert Review of Vaccines

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Whole-cell pertussis vaccines are still widely used across the globe and have been shown to produce longer lasting immunity against pertussis infection than acellular pertussis vaccines. Therefore, whole-cell vaccines are likely to continue to be used for the foreseeable future. The intracerebral mouse protection test (Kendrick test) is effective for determining the potency of whole-cell pertussis vaccines and is the only test that has shown a correlation with protection in children. Here we review the Kendrick test in terms of international requirements for vaccine potency and critical technical points to be considered for a successful test including test validity, in-house references and statistical analysis. There are objections to the Kendrick test on animal welfare and technical grounds. Respiratory challenge assays, nitric oxide induction assay and serological assays have been developed and have been proposed as possible methods which might provide alternatives to the Kendrick test. These methods and their limitations are also briefly discussed. Establishment of validated in vitro correlates of protection has yet to be achieved. New technical developments, such as genome sequence and the use of gene microarrays to screen responses triggered by vaccine components may also provide leads to alternative assays to the Kendrick test by identifying biomarkers of protection.

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Section: Serological Potency Assaymentioning

confidence: 99%

Whole-cell pertussis vaccine potency assays: the Kendrick test and alternative assays

Xing

Markey

Das

et al. 2014

Expert Review of Vaccines

View full text Add to dashboard Cite

show abstract

“…Indeed, the intracerebral mouse protection test (MPT.Ic) or Kendrick's test was the subject of our study, in order to develop the activity control of monovalent pertussis vaccines or associated with other antigens, and marketed in Algeria. However, and despite the variability that characterizes the mouse protection test (MPT), and the development of several alternative methods, such as the serological potency assay [25][26][27][28], the intra-nasal respiratory challenge test [29,30], and the nitric oxide and hydrogen superoxide assay [31,32], the (MPT) test remains the official potency test and the reference method for assessing the potency of pertussis vaccines [24]. In addition, it was the only test that shows a relationship with protection against pertussis in children in clinical trials [33].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Potency of the Pertussis Vaccine in Experimental Infection Model with Bordetella pertussis: Study of the Case of the Pertussis Vaccine Used in the Expanded Vaccination Program in Algeria

et al. 2022

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In Algeria, vaccination against pertussis is carried out using the whole-cell pertussis vaccine combined with the diphtheria and tetanus toxoids (DTwp). The quality control of vaccines locally produced or imported is carried out before the batch release. The aim of our work was to evaluate the potency of pertussis vaccines. In the present study, five consecutive trials of potency were conducted on samples of the same batch of (DTwp) using the mouse protection test (MPT) against experimental infection of Bordetella pertussis strain 18323, based on the Kendrick test. The virulence of B. pertussis strain 18–323 was verified by the mortality of mice, with an average LD50 of 338.92, as well as the dose of the lethal test containing a mean number of LD50 of 324.43. The (MPT) test recorded a relative potency of 8.02 IU/human dose, with 95% CL of (3.56–18.05) IU/human dose. The development of the (MPT) at the laboratory of quality control of vaccines and sera at the Pasteur Institute of Algeria was effective in evaluating the potency of whole-cell pertussis vaccines. Interestingly, our study indicates that this potency is necessary for the vaccine quality assurance. Further validation is needed to strengthen the application and routine use of the test.

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Principles of Vaccine Potency Assays

2018

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Compared with biologics, vaccine potency assays represent a special challenge due to their unique compositions, multivalency, long life cycles and global distribution. Historically, vaccines were released using in vivo potency assays requiring immunization of dozens of animals. Modern vaccines use a variety of newer analytical tools including biochemical, cell-based and immunochemical methods to measure potency. The choice of analytics largely depends on the mechanism of action and ability to ensure lot-to-lot consistency. Live vaccines often require cell-based assays to ensure infectivity, whereas recombinant vaccine potency can be reliably monitored with immunoassays. Several case studies are presented to demonstrate the relationship between mechanism of action and potency assay. A high-level decision tree is presented to assist with assay selection.

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Comparative analysis of the intracerebral mouse protection test and serological method for potency assays of pertussis component in DTP vaccine

Cited by 3 publications

References 7 publications

Whole-cell pertussis vaccine potency assays: the Kendrick test and alternative assays

Whole-cell pertussis vaccine potency assays: the Kendrick test and alternative assays

Evaluation of the Potency of the Pertussis Vaccine in Experimental Infection Model with Bordetella pertussis: Study of the Case of the Pertussis Vaccine Used in the Expanded Vaccination Program in Algeria

Principles of Vaccine Potency Assays

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