Research and Development Vicepresidency of Finlay Institute

Havana, Cuba

Research and Development Vicepresidency of Finlay Institute

Havana, Cuba
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Infante J.F.,Research and Development Vicepresidency of Finlay Institute | Sifontes S.,Research and Development Vicepresidency of Finlay Institute | Arencibia D.F.,Research and Development Vicepresidency of Finlay Institute | Hernandez T.,Research and Development Vicepresidency of Finlay Institute | And 2 more authors.
VacciMonitor | Year: 2012

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.


Acevedo R.,Research and Development Vicepresidency of Finlay Institute | Romeu B.,Research and Development Vicepresidency of Finlay Institute | Zayas C.,Research and Development Vicepresidency of Finlay Institute | Gonzalez E.,Research and Development Vicepresidency of Finlay Institute | And 5 more authors.
VacciMonitor | Year: 2012

Adjuvant Finlay Cochleate 1 (AFCo1) is a Proteoliposome-derived cochleate obtained from Neisseria meningitidis serogroup B. Transformation of proteoliposomes into AFCo1 potentiates the immune response on Neisseria antigens when it is administered by intranasal or intragastric (i.g) routes. However, the i.n route has been demonstrated to be more effective. The aim of this work is to evaluate in vitro the protein release from AFCo1, in simulated gastric fluid (SGF) or simulated nasal fluid (SNF) using a microdissolution test and to provide support for the results found when AFCo1 was administered by i.g or i.n routes in BALB/c mice. Results showed that dilution of AFCo1 in simulated gastric fluid affects the delivery of Neisseria protein antigens because they were released from cochleate structures faster than when simulated nasal fluid was used. In conclusion, conditions simulating gastric environment affect the delivery of protein antigens from AFCo1 and this result could partially explain why i.n administration is more effective in vivo than i.g immunisation.

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