某部甲型H1N1流感疫苗及季节性流感疫苗的接种效果与不良反应

Study on inummological effect and adverse reaction of influenza A （H1N1） vaccine and seasonal influenza vaccinein a military unit

目的了解甲型HIN1流感（pH1N1）疫苗和季节性流感疫苗（SIV）接种后的不良反应和疫苗接种前后的血清抗体水平变化，评价流感疫苗的安全性及免疫原性。方法760例符合要求人群随机分为pH1N1疫苗免疫组（VH组，460人）和SIV免疫组（VS组，300人），分别接种pH1N1疫苗和SIV，观察接种不良反应；应用微量血凝抑制试验（HI）方法对人群接种前、后进行血清抗体检测。结果760名疫苗接种者共发生不良反应57例（7．50％），未出现严重的不良反应。其中Ⅷ组发生不良反应为29例（6．30％），VS组发生不良反应为28例（9．33％），两组间不良反应的发生率差异无统计学意义（X^2=2．40，P〉0．05）。疫苗免疫21d后，VH组抗-pH1N1流感病毒抗体阳转率为95．65％，几何平均滴度倒数（GMRT）高达1：424．4（95％CI：325．07-523．76）。VS组抗．季节性流感病毒GMRT上升至1：183．8（95％CI：71．32-296．28）。结论pH1N1疫苗具有良好的安全性和免疫原性，适宜无接种禁忌症人群的普遍接种。

Objective To understand the antibody levels and adverse reaction （ADR） of healthy people before and after vaccinating pandemic influenza A H1N1 （pH1N1） vaccine and seasonal influenza vaccine（S1V）, and then evaluate the immunogenicity and safety of pH1N1 vaccine and SIV. Methods A total of 760 subjects who met the requirements were randomly individed into 2 groups： the pH1N1 vaccine recipients group （VH group, n = 460） and the SW recipients group （VS group, n = 300）. The ADR after immunization of 2 groups were recorded and analyzed respec- tively. The sera antibody levels were separately detected before and after immunization with two vaccines by the hemagglu- tination inhibition （HI） test. Results The total ADR rate of 760 cases was 7.50% （57 cases）, including 29 cases （6.30%） in VH group and 28 cases （9.33%） in VS group. ADR rate had no significant difference between 2 groups （ g2 = 2.40, P 〉 0.05）. No serious ADR was observed. Twenty one days after vaccination, anti-pH1Nl-positive sero- conversion rate was 95.65%, GMRT was estimated as 1：424.4（95% CI：325.07-523.76） in VH group; in VS group, the GMRT of anti-seasonal influenza virus increased to 1 ： 183.8（95% CI： 71.32-296.28）. Conclusions The pH1N1 vaccine shows good safety and immunogenicity. It is suit for the crowd without contraindications of vaccination universally.