流感亚单位疫苗与裂解疫苗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].

作者信息

Dong Pu-mei, Li Yu-qin, Zheng Tian-zhu, Jia Yong-pu, Li Feng, Han Tong-wu, Qiao Rong-xian, Zhang Bao-hua

机构信息

Zhengzhou Center for Disease Control, Zhengzhou 450053, China.

出版信息

Zhonghua Liu Xing Bing Xue Za Zhi. 2003 Jul;24(7):570-3.

PMID:12975010

Abstract

OBJECTIVE

To compare the reactogenicity and serology between influenza subunit vaccine and split vaccine.

METHODS

A randomized, double-blind study was carried out among children (age 6 - 12 years) in order to compare the safety and immunogenicity of an influenza inactivated subunit vaccine (Agrippal, Chiron Vaccines) with that of a split vaccine (Flurix, GSK).

RESULTS

A total of 499 subjects were vaccinated and included in the safety analysis. A total of 249 subjects received Agrippal and 250 received Flurix. All subjects were kept under medical observation for 30 minutes in order to check the evidence of having any immediate local and systemic reaction. Daily observation records were collected during the 3-day follow-up after vaccination. 6.4% of the cases with fever >or= 37.5 degrees C 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 D0 pre- and D23 post-vaccination sera) were collected from 224 of Agrippal group and 223 of Flurix group and analysed by the haemagglutination inhibition (HI) assay. Agrippal and Flurix induced similar seroprotection (HI titer >or= 1:40, H1N1 99.6% vs 100.0%; H3N2 99.1% vs 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 similar seroprotection rate (94.2% vs 96.4%) and GMT increase (21.2 vs 18.2) against the influenza 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 Agrippal group. Both vaccines induced an effective immune response in the vaccines.

摘要

目的

比较流感亚单位疫苗和裂解疫苗的反应原性及血清学情况。

方法

在6至12岁儿童中开展一项随机双盲研究，以比较流感灭活亚单位疫苗（阿格立普，赛诺菲德疫苗公司）和裂解疫苗（弗利克斯，葛兰素史克公司）的安全性和免疫原性。

结果

共有499名受试者接种疫苗并纳入安全性分析。249名受试者接种阿格立普，250名受试者接种弗利克斯。所有受试者均接受30分钟医学观察，以检查是否有任何即刻局部和全身反应迹象。接种疫苗后3天随访期间收集每日观察记录。弗利克斯组报告发热≥37.5℃的病例占6.4%，而阿格立普组为2.4%，显著低于前一组（P>0.05）。从阿格立普组的224名受试者和弗利克斯组的223名受试者采集血样（接种疫苗前D0和接种后D23血清），并通过血凝抑制（HI）试验进行分析。阿格立普和弗利克斯诱导的血清保护（HI效价≥1:40，H1N1为99.6%对100.0%；H3N2为99.1%对99.1%）和血清转化（4倍增长，95.1%对97.8%；H3N2为74.5%对79.8%）率以及针对两种甲型亚型的几何平均滴度（GMT）增长（16.0对21.0；5.4对6.4）相似。两种疫苗针对乙型流感毒株的血清保护率（94.2%对96.4%）和GMT增长（21.2对18.2）也相似。两种疫苗免疫测定结果无显著差异（P<0.05）。阿格立普组针对乙型毒株的血清转化率低于弗利克斯组（91.1%对97.3%）。