| Journal: | Vaccimonitor (La Habana) |
| Database: | PERIÓDICA |
| System number: | 000357836 |
| ISSN: | 1025-028X |
| Authors: | Infante, Juan Francisco1 Sifontes, Sergio1 Arencibia, Daniel Francisco1 Hernández, Tamara1 Fariñas, Mildrey1 Pérez, Oliver1 |
| Institutions: | 1Instituto Finlay, La Habana. Cuba |
| Year: | 2012 |
| Season: | Sep-Dic |
| Volumen: | 21 |
| Number: | 3 |
| Pages: | 1-5 |
| Country: | Cuba |
| Language: | Inglés |
| Document type: | Artículo |
| Approach: | Experimental |
| Spanish abstract | El cocleato AFCo1, derivado de un proteoliposoma de Neisseria meningitidis B, es un nuevo y potente adyuvante vacunal. En el presente trabajo se evaluó la seguridad del AFCo1 mediante un estudio de dosis repetida en ratas Sprague Dawley. Los animales se agruparon en: tratados con AFCo1, placebo y control. Se les administraron cuatro dosis de 100 µL durante 5 días por vía intranasal. Se monitoreo el peso corporal, consumo de agua y alimento y los síntomas clínicos; así como estudios hematológicos y bioquímicos. Las ratas se sacrificaron a los 3, 14 y 28 días después de la última inoculación y se les realizó, además, pruebas anatomopatológicas. Los síntomas clínicos, el consumo de agua y alimento y el peso corporal no mostraron diferencias de relevancia toxicológica. Los cambios histológicos encontrados fueron leves y con frecuencias similares en los tres grupos. Por lo que se concluyó que el adyuvante AFCo1 nasal es potencialmente no tóxico para uso en humanos, por la ausencia de signos locales y sistémicos de toxicidad en las ratas Sprague Dawley |
| English abstract | The AFCo1 cochleate is a potential novel adjuvant derived from Neisseria meningitidis B proteoliposome. The aim of this study was to assess the safety of AFCo1 by repeated doses in Sprague Dawley rats. Rats were grouped for treatment with AFCo1, placebo formulation or control. Four similar doses of the test substance were instilled every five days. Intranasal dose of 100 µL was used, and the body weight, water and food intakes were monitored as well as the clinical symptoms. Rats were sacrificed at 3, 14 and 28 days after the last inoculation and anatomopathological studies were conducted. Clinical observations were carried out for the study and a number of rats from each group were sacrificed 3 and 14 days after the last dose in order to conduct hematological, hemochemical and anatomopathological studies. Clinical symptoms, food and water intakes, and body weight did not show differences of toxicological relevance. The histological changes found were mild and similar in the three groups. AFCo1 is potentially safe by nasal route for human use as evidenced by the absence of local and systemic signs of toxicity in Sprague Dawley rats |
| Disciplines: | Medicina |
| Keyword: | Inmunología, Neisseria meningitidis, Proteoliposomas, Dosis, Toxicidad, Cocleatos, Adyuvantes, Respuesta inmune |
| Keyword: | Medicine, Immunology, Neisseria meningitidis, Proteoliposomes, Dose, Toxicity, Cochleates, Adjuvants, Immune response |
| Full text: | Texto completo (Ver PDF) |
