甲型H1N1流感病毒裂解疫苗的研制和临床观察初步结果

目的 研制甲型H1N1流感疫苗并进行人体安全性和有效性观察.方法 用WHO推荐的甲型H1N1流感疫苗毒种按照季节性流感裂解疫苗工艺研制甲型H1N1流感疫苗,成品参照流感病毒裂解疫苗质量标准进行各项指标检定,用2批血凝素含量不同的试制产品进行临床验证.结果 血凝素含量15μg/剂和30μg/剂各1批试制产品经检定并由中国药品生物制品检定所复检,符合暂定质量标准要求.临床观察显示,960名受试者接种15μg或30μg试验疫苗1针,21 d后血清抗体阳性率、保护率均大于70%.3～11岁、12～17岁、18～59岁及≥60岁,15μg组几何平均滴度(GMT)分别较免疫前增长15、39、37和25倍;30μg组GMT分别较免疫前增长26、72、68和36倍.安全性观察结果显示15μg和30μg组总的不良反应发生率为29.38%和43.75%,其中2级反应率为6.25%和15.42%,3级反应率为0.83%和1.46%,未观察到严重不良反应.结论 按照季节性流感生产工艺研制的甲型H1N1流感病毒裂解疫苗具有良好的安全性和有效性.

Preparation of influenza A (H1N1) split-virus vaccine and preliminary clinical trail

Objective To prepare an influenza A(H1N1) split-virus vaccine and observe its safe-ty and effectiveness. Methods According to the process for preparing seasonal flu split-virus vaccine two batches of vaccine were prepared with the flu A (H1N1) vaccine virus strain recommended by WHO. The pilot products were tested against the requirements of flu split-virus vaccine. Results The quality of the pi-lot vaccine has been tested by National Control Laboratory and conformed to the requirements. Nine hundred and sixty volunteers received one dose of vaccine containing either 15 μg or 30 μg of hemagglutinin. The re-suits indicated the both seroconversion rate and protection rate were higher the 70%. The GMT of HIAb of the volunteers who received 1 dose of 15 μg increased significantly by 15, 39, 37 and 25 times compared to those before vaccination in the age groups of 3-11, 12-17, 18-59 and ≥60, respectively. And 26, 72, 68 and 36 times rise were found in the postvaccinated volunteers of 30 μg group. The total adverse reaction rates of 15 μg and 30 μg dose group were 29.38% and 43.75%, respectively. The grade 2 adverse reaction rates of 15 μg and 30 μg dose group were 6.25% and 15.42%, and the grade 3 adverse reaction rates of 15 μg and 30 μg dose group were 0.83% and 1.46%, respectively. No serious adverse reactions were found. Conclusion The influenza A (H1N1) split-virus vaccine prepared according to the requirements of season-al flu vaccine is safe and effective.