RESULTS OF PRECLINICAL STUDIES OF LIVE MONOVALENT INFLUENZA VACCINE INFLUVIR

Aim. To perform preclinical assessment of new live monovalent vaccine Influvir against pandemic influenza virus A/H1N1 [strain A/17/California/2009/38 (H1N1)]. Materials and methods. Preclinical studies of acute toxicity and effect of Influvir vaccine on systems and organs of laboratory animals (rats and outbred white mice) was performed according to modern requirements of Institute of Toxicology. Results. According to results of toxicometry and necroscopy, live monovalent influenza vaccine Influvir during intransal application was safe and had good tolerability during 14 days of observation for experimental animals after acute application. Performed preclinical studies allow to label the studied vaccine as class V virtually nontoxic drugs. Conclusion. According to results of preclinical studies, clinical trials of live monovalent intranasal influenza vaccine Influvir can be permitted.

influenza A/H1N1, pandemic, preclinical studies, acute toxicity, intranasal application