Zverev V V, Kostinov M P, Mikhailova N A, Zhirova S N, Mironov A N, Terkacheva O A, Romanova A A, Cherdantsev A P
Vopr Virusol. 2011 May-Jun;56(3):20-3.
The immunogenicity of Pandeflu subunit vaccine against influenza A/California/7/2009 (H1N1) was evaluated in 70 healthy volunteers aged 18 to 60 years. The vaccine was intramuscularly injected twice at an interval of 28 days. Each dose (0.5 ml) contains A(HIN1) influenza virus hemagglutinin (15 +/- 2.2 microg), aluminum hydroxide (Denmark) (0.475 +/- 0.075 microg), and the preservative thiomerosal (merthiolate) (50 +/- 7.5 microg). The level of antibodies was determined in the microneutralization assay. After administration of two doses of the vaccine at a 28-day interval, the geometric mean antibody titer (GMAT) reached 1:21.1 with a further increase to 1:30 (the baseline GMAT) was 1:6.1). The frequencies of seroconversion and seroprotection were 71.4 and 59.2%, respectively; the antibody increase factor was 4.92, which meets the CPMP criteria. The administration of the vaccine did not result in adverse reactions in the postvaccination period.
在70名年龄在18至60岁的健康志愿者中评估了Pandex流感亚单位疫苗针对甲型/加利福尼亚/7/2009（H1N1）流感的免疫原性。疫苗通过肌肉注射分两次给药，间隔28天。每剂（0.5毫升）含有甲型（H1N1）流感病毒血凝素（15±2.2微克）、氢氧化铝（丹麦）（0.475±0.075微克）和防腐剂硫柳汞（硫柳汞）（50±7.5微克）。通过微量中和试验测定抗体水平。在间隔28天接种两剂疫苗后，几何平均抗体滴度（GMAT）达到1:21.1，进一步升至1:30（基线GMAT为1:6.1）。血清转化率和血清保护率分别为71.4%和59.2%；抗体增加因子为4.92，符合欧洲药品评价局的标准。接种疫苗后未出现不良反应。
