彭松青, 崔伟红, 冯国跃, 李波, 姜梅. 学龄儿童10 μg汉逊酵母重组乙肝疫苗加强免疫的效果及安全性评价[J]. 上海预防医学, 2015, 27(3): 116-118,124.
引用本文: 彭松青, 崔伟红, 冯国跃, 李波, 姜梅. 学龄儿童10 μg汉逊酵母重组乙肝疫苗加强免疫的效果及安全性评价[J]. 上海预防医学, 2015, 27(3): 116-118,124.
PENG Song-qing, CUI Wei-hong, FENG Guo-yue, LI Bo, JIANG Mei. Efficacy and safety evaluation on 10 μg Hansenula recombinant hepatitis B vaccine booster for school-age children[J]. Shanghai Journal of Preventive Medicine, 2015, 27(3): 116-118,124.
Citation: PENG Song-qing, CUI Wei-hong, FENG Guo-yue, LI Bo, JIANG Mei. Efficacy and safety evaluation on 10 μg Hansenula recombinant hepatitis B vaccine booster for school-age children[J]. Shanghai Journal of Preventive Medicine, 2015, 27(3): 116-118,124.

学龄儿童10 μg汉逊酵母重组乙肝疫苗加强免疫的效果及安全性评价

Efficacy and safety evaluation on 10 μg Hansenula recombinant hepatitis B vaccine booster for school-age children

  • 摘要: 目的评价学龄儿童加强接种10 μg汉逊酵母重组乙肝疫苗的安全性和免疫效果,为制定乙肝免疫预防策略提供依据。方法选取2 101名学龄儿童作为安全性观察的研究对象,对所有对象接种3针10 μg汉逊酵母重组乙肝疫苗,观察不良反应的发生率。同时,对其中404名儿童进行免疫效果观察,对比加强免疫前后抗体浓度及阳性率的变化。结果2 101名受试儿童中,共发生不良反应85例,发生率为4.05%,其中84例为轻度反应,1例为中度反应,无重度反应。疫苗接种后,人群保护性抗体的阳性率为100.00%,抗体浓度由接种前的2.55 IU/L上升为接种后的5 051.90 IU/L,差异有统计学意义(Z=12.51,P=0.00)。结论汉逊酵母重组乙肝疫苗用于学龄儿童加强免疫具有良好的安全性,免疫效果良好。

     

    Abstract: Objective To assess the safety and immunogenicity of booster vaccination 10 μg of recombinant Hansenula hepatitis B vaccine in school-age children, and to provide scientific basis for the development of hepatitis B immunization strategies. Methods A total of 2 101 children were selected as the safety study object and were inoculated with three injections of 10 μg Hansenula hepatitis B vaccine for observation of the incidence of abnormal reaction. Among them 404 schoolchildren were observed for immune effects. And comparison was made in the difference of antibody titers and antibody positive rate before and after immunization.Results Of the 2 101 children, 85 cases of adverse reactions occurred and the incidence rate was 4.05%. Of the 85 cases, 84 had slight reactions, one with moderate reactions and none with severe reactions. After vaccination, the positive rate of protective antibodies increased to 100.00%, and antibody titers rose from 2.55 IU/L to 5 051.90 IU/L, the difference being statistically significant (Z=12.51, P=0.00).Conclusion Hansenula hepatitis B vaccine used for booster immunization in schoolchildren is of good security and fine immune effect.

     

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