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Human & Experimental Toxicology
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Toxicology and biodistribution study of CIGB-230, a DNA vaccine against hepatitis C virus

Dania Bacardí

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba, dania.bacardi{at}cigb.edu.cu

Yalena Amador-Cañizares

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Karelia Cosme

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Dioslaida Urquiza

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

José Suárez

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Jeny Marante

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Ariel Viña

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Ariel Vázquez

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Joel Concepción

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Maylín Pupo

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Lizet Aldana

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Yordanka Soria

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Juan Romero

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Roberto Madrigal

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Leticia Martínez

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Lourdes Hernández

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Idania González

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

Santiago Dueñas-Carrera

Center for Genetic Engineering and Biotechnology, Cubanacán, Playa, Havana, Cuba

CIGB-230, a mixture of a DNA plasmid expressing hepatitis C virus (HCV) structural antigens and a HCV recombinant capsid protein, has demonstrated to elicit strong immune responses in animals. The present study evaluated the plasmid biodistribution after the administration of CIGB-230 in mice, as well as toxicity of this vaccine candidate in rats. In the biodistribution study, mice received single or repeated intramuscular injections of CIGB-230, 50 µg of plasmid DNA mixed with 5 µg of Co.120 protein. Plasmid presence was assessed in ovaries, kidney, liver, pancreas, mesenteric ganglion, blood, and muscle of the injection site by a qualitative polymerase chain reaction. The toxicology evaluation included treatment groups receiving doses 5, 15, or 50 times higher, according to the body weight, than the expected therapeutic clinical dose. During the first hour after repeated inoculation, a promiscuous distribution was observed. However, 3 months later, plasmid could not be detected in any tissue. There was an absence of detectable adverse effects on key toxicology parameters and no damage evidenced in inspected organs and tissues. These results indicate that CIGB-230 is nontoxic at local and systemic levels and no concerns about persistence are observed, which support clinical testing of this vaccine candidate against HCV.

Key Words: DNA vaccine • HCV • systemic effects • toxicity • tissue

This version was published on August 1, 2009

Human & Experimental Toxicology, Vol. 28, No. 8, 479-491 (2009)
DOI: 10.1177/0960327109106438
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