Safety and tolerability of mice to repeated subcutaneous injections of a peptide mix as a potential vaccine against HCV infection

摘要

BACKGROUND AND AIMS: In this study, the safety and tolerability of new candidate HCV vaccine named Cenv6 were screened in mice. Cenv6 peptide is composed of 6 synthetic HCV peptides (3 structural and 3 nonstructural peptides). METHODS: Forty eight mice were enrolled in this study, 12 controls and 36 mice (the thirty-six mice were categorized into 3 groups according to administered doses (3 monthly doses of 800 ng, 1600 ng, and 16 μ g/25 gm mouse body weight (bw))). Hematological, biochemical and histopathological changes were appraised. RESULTS: Our data indicated that the doses of 800 ng and 1600 ng of Cenv6 per 25 gm mouse body weight were safe as compared to the dose 16 μ g/25 gm bw (10 times more than the potential therapeutic dose) for all examined tissues while the 16?μ g Cenv6 dose provoked histopathological changes in kidneys, liver and lungs. CONCLUSIONS: The extravagant histopathological changes in different organs have exiled the 16 μ g dose out of acceptable range and validated that Cenv6 is safe and tolerable at the two lower doses (800 and 1600 ng/25 gm bw).