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Research Article

Repeated dose toxicity study of Vibrio cholerae-loaded gastro-resistant microparticles

, , , , , , , , , , , & show all
Pages 86-92 | Received 14 Nov 2012, Accepted 13 May 2013, Published online: 24 Jun 2013
 

Abstract

Context: Microencapsulation of antigens has been extensively studied over the last decades aiming at improving the immunogenicity of vaccine candidates.

Objective: Addressing microparticles (MPs) toxicity in rats.

Material and methods: Spray-dried Eudragit® L 30 D-55 MPs and Eudragit® L 30 D-55 alginate MPs were elaborated and characterized. MPs obtained were administered to rats, three groups were defined: G1, control group; G2, administered with Vibrio cholerae (VC)-loaded MPs; G3, receiving VC-loaded alginate MPs. Animals received three vaccine doses. Body weight, food and water intake were controlled during the study. Haematological parameters, vibriocidal titres, organ weight and histology in necropsy were also analyzed.

Results: All animals grew healthy. Body weight gain, food and water intake and haematological parameters remained within physiological values, showing no treatment-related differences. Moreover, organ weight changes were not detected and animals developed protective vibriocidal titres.

Conclusion: VC-loaded MPs and VC-loaded alginate MPs have proved to be safe and effective in the assessed conditions.

Acknowledgements

The authors would like to thank Evonik Industries for kindly providing Eudragit® L 30 D-55. Authors also acknowledge the technical support and advice provided by SGIker (UPV/EHU, MICINN, GV/EJ and ESF) on scanning electron microscope. The authors gratefully acknowledge the support of University of the Basque Country UPV/EHU (UFI 11/32).

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