Mel'nikov S Ia, Zverev V V, Korovkin S A, Mironov A N, Dyldina N V, Mikhaĭlova N A, Faĭzuloev E B, Lotte V D
Zh Mikrobiol Epidemiol Immunobiol. 2009 Jan-Feb(1):21-6.
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.
研发出了新型俄罗斯流感病毒体裂解疫苗“Grifor”。该疫苗由甲型流感病毒（H1N1和H3N2）和乙型流感病毒高度纯化的保护性外部及内部抗原混合而成。所研发的生产技术能够使流感病毒的外部抗原以病毒体形式呈现，内部抗原以微团形式呈现，且最大程度地保留其抗原活性。利用电子显微镜、十二烷基硫酸钠-10%聚丙烯酰胺凝胶电泳以及聚合酶链反应，对该疫苗的形态学和生化特性进行了研究。开展了临床前研究，包括将“Grifor”疫苗与“Vaxigrip”（法国）疫苗的抗原特性进行比较。结果表明，接种该疫苗不会导致实验动物死亡、体重减轻，不会使内脏出现病理性（包括炎症性、营养不良性和坏死性）变化，也不会对血液血液学和生化参数以及免疫系统产生不良影响。该疫苗无致热原性和致敏性，无局部刺激作用。所得结果支持在有限数量的志愿者身上开展“Grifor”疫苗临床试验的合理性。
