Mironov A N, Romanova A A, Dyldina N V, Bushmenkov D S, Tsaan A A, Alsynbaev M M, Zagidullin N V, Kolbasov S E
Zh Mikrobiol Epidemiol Immunobiol. 2010 May-Jun(3):27-32.
To perform preclinical study of subunit monovalent adsorbed inactivated influenza vaccine "PANDEFLU" [strains A/California/7/2009 (HIN1)v].
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).
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.
对单价吸附亚单位灭活流感疫苗“PANDEFLU”[A/California/7/2009（HIN1）v株]进行临床前研究。
对实验动物进行急性毒性临床前研究（评估疫苗对器官和身体系统的毒性作用；接种疫苗后对器官和组织进行病理形态学研究；评估其对血液学指标的影响）。
结果表明，接种疫苗未导致动物死亡，也未导致体重减轻或实质细胞和内脏基质出现病理性局灶性硬化改变；疫苗未对血液的血液学和生化指标产生负面影响。按标准剂量急性接种疫苗后的尸检和组织学研究结果未导致接种部位组织出现刺激、炎症或破坏。该疫苗无热原性，无局部刺激和过敏作用。急性接种疫苗后动物的状况表明，其在超过标准人用剂量十倍以上的剂量下具有良好的耐受性和安全性。结论。所进行的研究表明，对有限数量的志愿者进行“PANDEFLU”疫苗临床试验不存在禁忌证。
