| 董蒲梅,李玉秦,郑天柱,贾永普,李锋,韩同武,乔荣宪,张保华.流行性感冒灭活亚单位疫苗和裂解疫苗的安全性和免疫原性的比较研究[J].Chinese journal of Epidemiology,2003,24(7):570-573 |
| 流行性感冒灭活亚单位疫苗和裂解疫苗的安全性和免疫原性的比较研究 |
| Comparative study on safety and immunogenicity between influenza subunit vaccine and split vaccine |
| Received:March 05, 2003 |
| DOI： |
| KeyWord: 流感疫苗 亚单位疫苗 裂解疫苗 临床观察 |
| English Key Word: Influenza vaccine Subunit vaccine Split vaccine Clinical study |
| FundProject: |
| Author Name | Affiliation | | Dong Pumei | Zhengzhou Center for Disease Control, Zhengzhou 450053, China | | Li Yuqin | Zhengzhou Center for Disease Control, Zhengzhou 450053, China | | Zheng Tianzhu | Zhengzhou Center for Disease Control, Zhengzhou 450053, China | | Jia Yongpu | Zhengzhou Center for Disease Control, Zhengzhou 450053, China | | Li Feng | Zhengzhou Center for Disease Control, Zhengzhou 450053, China | | Han Tongwu | Zhengzhou Center for Disease Control, Zhengzhou 450053, China | | Qiao Rongxian | Zhengzhou Center for Disease Control, Zhengzhou 450053, China | | Zhang Baohua | 河南省疾病预防控制中心流感监测中心 450053 |
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| Abstract: |
| 目的 比较流感亚单位疫苗与裂解疫苗的安全性和免疫原性.方法 流感亚单位疫苗和裂解疫苗按随机双盲法分别接种249名和250名6～12岁健康儿童.于接种当日和接种后3天内观察局部反应和全身反应.用血凝抑制试验检测接种儿童免疫前后的血凝抑制抗体(HI)滴度,计算抗体4倍增长阳转率,免疫后的保护水平抗体(≥1∶40)的免疫成功率,以及抗体几何平均滴度(GMT)值和增长倍数.比较流感亚单位疫苗和裂解疫苗的临床观察结果.结果 两种疫苗接种后均未见局部反应,发热反应率和中高度发热反应率亚单位疫苗低于裂解疫苗,两组的差异有显著的统计学意义.未见其他全身反应.对疫苗 3个毒株的血清学检测结果显示:亚单位疫苗的阳转率为74.5%～95.1%,保护水平抗体的免疫成功率为94.2 %～99.6%,抗体GMT增长倍数为5.4～21.2.裂解疫苗的阳转率79.8%～97.8%,保护水平抗体的免疫成功率为96.4%～100.0%,抗体GMT增长倍数6.4～21.0.两种疫苗的免疫学效果相似,所见差异无显的统计学意义.结论 流感亚单位疫苗和裂解疫苗接种6～12岁儿童后反应轻微,安全性良好,亚单位疫苗发热反应率低于裂解疫苗.两种疫苗的免疫原性良好,具有同样显著的免疫效果,可以推广使用. |
| English Abstract: |
| Objective To compare the reactogenicity and serology between influenza subunit vaccine and split vaccine.Methods A rand-omized double-blind study was carried out among children(age 6一12year) in order to compare the safety and immunogenicity of an infl-uenza inactivated subunit vaccine(Agrippal,Chiron Vaccines) with that of a split vaccine(Flurix,GSK).ResultsA total of 499 subj-ects were vaccinated and included in the safety analysis.A total of 249 subjects received Agrippal and 250 received Flurix.All subj-ects were kept under medical observation for 30 minutes in order to check the evidence of having any immediate local and systemic reac-tion. Daily observation records were collected during the 3-day follow-up after vaccination. 6.4%of the cases with fever≥37.5 ℃ was reported in the Flurix group but 2.4%in Agrippal group which was significantly less than the former group(P>0.05). Blood samples(the DO pre- and D23 post-vaccination sera) were collected from 224 of Agrippal group and 223 of Flurix group and analysed by the haemaggluti-nation inhibition(HI)assay. Agrippal and Flurix induced similar seroprotection(HI titerv1:40， HINT 99.6% vs 100.0%;H3N2 99.1%。99.1%)
and seroconversion(4-fold increase 95.1% vs 97.8%;H3N2 74.5% vs 79.8%)rates and geometric mean titer(GMT)increase(16.0 vs 21.0) 5.4 vs 6.4)against the two A subtypes. A similarseroprotection rate(94.2% vs 96.4%)and GMT increase(21.2 vs 18. 2) against the i-nfluenza B strain were also noticed in both vaccines. No significant difference was found in the results of immunological assay between the two vaccines(P<0.05).A lower seroconversion rate against B strain was observed in Agrippal group than in Flurix group (91.1%vs 97.3%). Conclusion In terms of safety both vaccines were generally well tolerated.The fever reaction was less frequently seen in the Agri-ppal group.Both vaccines induced an effective immune response in the vaccines. |
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