Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/27969
Title: Potency evaluation of rabies vaccine for human use: the impact of the reduction in the number of animals per dilution
Authors: Moura, Wlamir Corrêa de
Araujo, Humberto Pinheiro de
Cabello, Pedro Hernan
Romijn, Phyllis Catharina
Leite, José Paulo Gagliardi
Affilliation: Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Departamento de Imunologia. Rio de Janeiro, RJ. Brasil / Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Programa de Pós-Graduação em Vigilância Sanitária. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Departamento de Imunologia. Rio de Janeiro, RJ. Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Departamento de Genética. Rio de Janeiro, RJ. Brasil.
Secretaria Estadual de Saúde. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Virologia Comparada. Rio de Janeiro, RJ. Brasil.
Abstract: In order to evaluate the effects of reducing the number of animals used in the NIH mouse protection test for potency determination of inactivated rabies vaccines for human use, a retrospective study of the results obtained in the Brazilian National Control Laboratory, Instituto Nacional de Controle de Qualidade em Saúde (INCQS), was performed, comprising 214 vaccine lots. The INCQS Standard Operating Procedure establishes the use of three vaccine dilutions and 18 animals per dilution, separated into two cages with 9 mice each. The results of the two cages of each dilution were considered as two different groups (C1 and C2), and therefore, for each vaccine lot, three results were obtained: one for the standard test (ST) with 18 mice, one using the C1 cages with 9 mice and another using the C2 cages with 9 mice. The results were evaluated as repeated measures of the same method on the same samples. In this study, the effects of the reduction in: (a) the measurement error and its association with the size of measurement, (b) the agreement between the results using the concordance coefficient of correlation, (c) the agreement of categorized results as "Pass" or "Fail" using the Kappa index, (d) the precision of potency determinations using the 95% confidence interval and (e) the incidence of statistically invalid assays due to non-linearity and non-parallelism were evaluated. It was concluded that the results from the NIH mouse protection test using 9 mice per dilution are in good agreement with the results obtained using 18 mice per dilution. Therefore, nine animals per dilution is a suitable number to meet the statistical requirement for valid assays.
Keywords: Rabbies vaccine
NIH test
Potency testing
3Rs
keywords: vacina anti-rábica
Teste de potência
Issue Date: 2009
Publisher: 1879-0984
Citation: MOURA, Wlamir Corrêa de; et al. Potency evaluation of rabies vaccine for human use: The impact of the reduction in the number of animals per dilution. Journal of Virological Methods, v.158, p.84–92, Jan. 2009.
DOI: 10.1016/j.jviromet.2009.01.017
ISSN: 0166-0934
Copyright: restricted access
Appears in Collections:IOC - Artigos de Periódicos

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