title: [Development and preclinical study of new generation virosomal split influenza vaccine "Grifor"].
abstract: New Russian virosomal split vaccine against influenza "Grifor" was developed. The vaccine is represented by mix of highly purified protective external and internal antigens of influenza A (H1N1 and H3N2) and B viruses. Developed technology of manufacture allowed to provide presentation of external antigens of influenza virus in the form of virosomes, and presentation of internal antigens in the form of micelles with maximal preservation of their antigenic activity. Using electron microscopy, electrophoresis in 10% polyacrilamide gel with sodium dodecyl sulfate, and polymerase chain reaction, morphologic and biochemical properties of the vaccine were studied. Preclinical study, including assessment of antigenic characteristics of "Grifor" vaccine compared to vaccine "Vaxigrip" (France), was performed. It was established that administration of the vaccine did not result in death of experimental animals, decrease of body mass, development of pathologic (including inflammatory, dystrophic and necrobiotic) changes in viscera or render adverse effects on blood hematologic and biochemical parameters and on the immune system. The vaccine was not pyrogenic and allergenic, did not have local irritating effects. Obtained results supported the appropriateness of conducting the clinical trials of "Grifor" vaccine on limited number of volunteers.
authors.forename: S Ia
authors.initials: SIa
authors.lastname: Mel'nikov
authors.forename: V V
authors.initials: VV
authors.lastname: Zverev
authors.forename: S A
authors.initials: SA
authors.lastname: Korovkin
authors.forename: A N
authors.initials: AN
authors.lastname: Mironov
authors.forename: N V
authors.initials: NV
authors.lastname: Dyldina
authors.forename: N A
authors.initials: NA
authors.lastname: Mikhaĭlova
authors.forename: E B
authors.initials: EB
authors.lastname: Faĭzuloev
authors.forename: V D
authors.initials: VD
authors.lastname: Lotte