Live attenuated pandemic influenza vaccine: clinical studies on A/17/California/2009/38 (H1N1) and licensing of the Russian-developed technology to WHO for pandemic influenza preparedness in developing countries.

In February 2009, Nobilon granted the World Health Organization (WHO) a non-exclusive licence to develop, register, manufacture, use and sell seasonal a pandemic live attenuated influenza vaccine (LAIV) produced on embryonated chicken eggs. WHO was permitted to grant sub-licences to vaccine manufacturers in developing countries within the framework of its influenza vaccine technology transfer initiative. In parallel, the Institute of Experimental Medicine (IEM), Russia, concluded an agreement with WHO for the supply of Russian LAIV reassortants for use by these manufacturers.

[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.

[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 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.