Assessment of repeat dose toxicity of Cochleate derived from Neisseria meningitidis proteoliposome in Sprague Dawley rats

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...

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Main Authors: Juan Francisco Infante, Sergio Sifontes, Daniel Francisco Arencibia, Tamara Hernández, Mildrey Fariñas, Oliver Pérez
Format: Article
Language:English
Published: Finlay Ediciones 2012-12-01
Series:VacciMonitor
Subjects:
Online Access:http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1025-028X2012000300001&lng=es&nrm=iso&tlng=en
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author Juan Francisco Infante
Sergio Sifontes
Daniel Francisco Arencibia
Tamara Hernández
Mildrey Fariñas
Oliver Pérez
author_facet Juan Francisco Infante
Sergio Sifontes
Daniel Francisco Arencibia
Tamara Hernández
Mildrey Fariñas
Oliver Pérez
author_sort Juan Francisco Infante
collection DOAJ
description 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.
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spelling doaj.art-756e2938215b47558b3c32558cdb3fd72022-12-21T23:16:06ZengFinlay EdicionesVacciMonitor1025-028X1025-02982012-12-0121315Assessment of repeat dose toxicity of Cochleate derived from Neisseria meningitidis proteoliposome in Sprague Dawley ratsJuan Francisco Infante 0Sergio Sifontes1Daniel Francisco Arencibia 2Tamara Hernández3Mildrey Fariñas4Oliver Pérez 5Research and Development Vicepresidency of Finlay Institute, Havana, Cuba.Research and Development Vicepresidency of Finlay Institute, Havana, Cuba.Research and Development Vicepresidency of Finlay Institute, Havana, Cuba.Research and Development Vicepresidency of Finlay Institute, Havana, Cuba.Research and Development Vicepresidency of Finlay Institute, Havana, Cuba.Research and Development Vicepresidency of Finlay Institute, Havana, Cuba.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.http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1025-028X2012000300001&lng=es&nrm=iso&tlng=enneisseria meningitidisSprague Dawleyrepeated doseproteoliposome
spellingShingle Juan Francisco Infante
Sergio Sifontes
Daniel Francisco Arencibia
Tamara Hernández
Mildrey Fariñas
Oliver Pérez
Assessment of repeat dose toxicity of Cochleate derived from Neisseria meningitidis proteoliposome in Sprague Dawley rats
VacciMonitor
neisseria meningitidis
Sprague Dawley
repeated dose
proteoliposome
title Assessment of repeat dose toxicity of Cochleate derived from Neisseria meningitidis proteoliposome in Sprague Dawley rats
title_full Assessment of repeat dose toxicity of Cochleate derived from Neisseria meningitidis proteoliposome in Sprague Dawley rats
title_fullStr Assessment of repeat dose toxicity of Cochleate derived from Neisseria meningitidis proteoliposome in Sprague Dawley rats
title_full_unstemmed Assessment of repeat dose toxicity of Cochleate derived from Neisseria meningitidis proteoliposome in Sprague Dawley rats
title_short Assessment of repeat dose toxicity of Cochleate derived from Neisseria meningitidis proteoliposome in Sprague Dawley rats
title_sort assessment of repeat dose toxicity of cochleate derived from neisseria meningitidis proteoliposome in sprague dawley rats
topic neisseria meningitidis
Sprague Dawley
repeated dose
proteoliposome
url http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1025-028X2012000300001&lng=es&nrm=iso&tlng=en
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