[Results of preclinical study of inactivated subunit adsorbed monovalent influenza vaccine "PANDEFLU"].

AIM: To perform preclinical study of subunit monovalent adsorbed inactivated influenza vaccine "PANDEFLU" [strains A/California/7/2009 (HIN1)v]. MATERIALS AND METHODS: Preclinical study of acute toxicity on experimental animals (assessment of vaccine's toxic effects on organs and body systems; pathomorphologic study of organs and tissues after administration of the vaccine; assessment of its influence on hematologic indicators). RESULTS: It was shown that administration of the vaccine did not lead to death of animals as well as to decrease of body mass or development of pathologic, focal sclerotic changes in parenchymal cells and visceral stroma; the vaccine did not negatively change hematologic and biochemical indicators of blood. Results of necropsy and histological study after acute administration of the vaccine in standard dose did not lead to irritation, inflammation or destruction of tissues in the place of inoculation. The vaccine was apyrogenic and did not have local irritating and allergenic effects. Status of animals after acute inoculation of the vaccine demonstrated its good tolerability and safety in doses exceeding standard human doses more than tenfold. CONCLUSION. Performed research demonstrated absence of contraindications for conduction of clinical trials of "PANDEFLU" vaccine on limited contingent of volunteers.

[Study of tolerability and reactogenicity of pandemic vaccines against influenza type A/H1N1].

AIM: To study tolerability and safety of pandemic vaccines against influenza A/H1N1 "INFLUVIR" and "PANDEFLU" on limited group of volunteers during phase I clinical trial. MATERIALS AND METHODS: Thirty healthy volunteers were participated in phase I clinical trial. Clinical and laboratory tests of volunteers randomized to 2 groups (20 persons received vaccine and 10 persons - placebo) were performed. "INFLUVIR" vaccine was administered by intranasal route. Volunteers were hospitalized and followed up for development of local and systemic adverse events during 7 days after vaccination. "PANDEFLU" was administered intramuscularly; vaccinees were followed for 7 days in outpatient settings. RESULTS. Phase I clinical trial showed good tolerability and low reactogenicity of "INFLUVIR" and "PANDEFLU" vaccines. There were no moderate and severe local and systemic adverse events registered. CONCLUSION: On the basis of performed phase I clinical trial, phase II trial was recommended to perform in order to assess the reactogenicity, safety and immunogenicity of studied vaccines.

[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 [strainA/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.