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Unexpected inefficiency of the European pharmacopoeia sterility test for detecting contamination in clostridial vaccines

Investigation article published in Vaccine

March 1st, 2006

Three outbreaks of clostridial disease in ruminants were reported in Spain. Out of 202,525 animals in affected herds, 41,767 were infected and 22,189 died. Epidemiological investigation linked these outbreaks with vaccination with three different commercial anti-clostridial vaccines contaminated with Clostridium sordellii. Vaccines were produced by the same manufacturer. Microbiological and molecular genetic analyses confirmed this association, and isolates of C. sordellii with identical biochemical and pulsed-field gel electrophoresis (PFGE) macrorestriction patterns were isolated from both diseased animals and the epidemiologically related vaccines. Contamination of the commercial vaccines was not detected by the sterility test proposed by the European (EU) Pharmacopoeia. However, growth was obtained when the commercial vaccines were inoculated into specific culture media for Clostridium and incubated for up to 60 days




Tellez S., Casimiro R., Vela AI., Fernandez-Garayzabal JF., Ezquerra R., Latre MV., Briones V., Goyache J., Bullido R., Arboix M. and Dominguez L..




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Unexpected inefficiency of the European pharmacopoeia sterility test for detecting contamination in clostridial vaccines

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Unexpected inefficiency of the European pharmacopoeia sterility test for detecting contamination in clostridial vaccines


Participants:

Universidad ComplutenseServicio de Identificación y Caracterización Microbiana (ICM). Centro de Vigilancia Sanitaria Veterinaria (VISAVET). Universidad Complutense (UCM).

Universidad ComplutenseDepartamento de Sanidad Animal. Facultad de Veterinaria. Universidad Complutense (UCM).

Agencia Española del Medicamento (AGEMED).

Universidad de ZaragozaDepartamento de Patología Animal. Facultad de Veterinaria. Universidad de Zaragoza (UNIZAR).







Vaccine
FACTOR YEAR Q
3.159 2006

NLMID: 8406899

PMID: 16430996

ISSN: 0264-410X



TITLE: Unexpected inefficiency of the European pharmacopoeia sterility test for detecting contamination in clostridial vaccines


JOURNAL: Vaccine


NUMERACIÓN: 24(10):1710-15


AÑO: 2006


PUBLISHER: Elsevier Science


AUTHORS: Tellez S., Casimiro R., Vela AI., Fernandez-Garayzabal JF., Ezquerra R., Latre MV., Briones V., Goyache J., Bullido R., Arboix M. and Dominguez L..


VISAVET PARTICIPANTS


3rd
Ana Isabel Vela Alonso
4th
José Francisco Fernández-Garayzabal Fernández
7th
Víctor Briones Dieste
8th
Joaquín Goyache Goñi
Last
Lucas Domínguez Rodríguez

DOI: https://doi.org/ 10.1016/j.vaccine.2005.12.037


CITE THIS PUBLICATION:

Tellez S., Casimiro R., Vela AI., Fernandez-Garayzabal JF., Ezquerra R., Latre MV., Briones V., Goyache J., Bullido R., Arboix M. and Dominguez L. Unexpected inefficiency of the European pharmacopoeia sterility test for detecting contamination in clostridial vaccines. Vaccine. 24(10):1710-15. 2006. (A). ISSN: 0264-410X. DOI: 10.1016/j.vaccine.2005.12.037


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