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

Yulieé López1, Marta Pastor, Juan Francisco Infante

  • 1Finlay Institute, Centro de Investigación-Producción de vacunas y sueros , 27 Avenue No. 19805, La Lisa, Ciudad de la Habana, A.P. 16017, Cod. 11600 , Cuba .

Journal of Microencapsulation
|June 26, 2013
PubMed
Abstract

Insights

Microparticles (MPs) loaded with Vibrio cholerae (VC) antigens were evaluated for toxicity in rats. The results demonstrate that both Eudragit® and alginate MPs are safe and effective vaccine delivery systems.

Area of Science:

  • Biomaterials Science
  • Vaccinology
  • Toxicology

Background:

  • Microencapsulation enhances vaccine immunogenicity.
  • Assessing the safety of microparticles (MPs) is crucial for vaccine development.

Purpose of the Study:

  • To evaluate the toxicity of Eudragit® L 30 D-55 microparticles (MPs) and Eudragit® L 30 D-55 alginate MPs in a rat model.
  • To determine the safety and efficacy of microparticle-based vaccines against Vibrio cholerae (VC).

Main Methods:

  • Spray-dried Eudragit® L 30 D-55 MPs and alginate MPs were prepared and characterized.
  • Rats were administered VC-loaded MPs or alginate MPs over three doses.
  • Key parameters including body weight, food/water intake, hematology, organ weight, and vibriocidal antibody titers were analyzed.

Main Results:

  • No significant adverse effects were observed in body weight, food/water intake, or hematological parameters.
  • Organ weights remained normal, indicating no treatment-related toxicity.
  • Animals vaccinated with VC-loaded MPs developed protective vibriocidal antibody titers.

Conclusions:

  • Eudragit® L 30 D-55 MPs and Eudragit® L 30 D-55 alginate MPs are safe for use as vaccine delivery vehicles.
  • The microparticle formulations demonstrated efficacy in inducing protective immunity against Vibrio cholerae.

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