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[目的]评价学龄儿童加强接种10μg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10μg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2.55IU/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。
[Objective] To evaluate the safety and immune effect of school-age children inoculated with 10μg Hansenula recombinant hepatitis B vaccine and provide basis for formulating hepatitis B immune prevention strategy. [Methods] A total of 2 101 school-age children were enrolled in the study. All subjects were vaccinated with 3 doses of 10 μg Hansenula Recombinant Hepatitis B Vaccine to observe the incidence of adverse reactions. At the same time, 404 children were observed for the immune effect, comparing the antibody concentration and the positive rate before and after the immunization. [Results] There were 85 adverse reactions in 2 101 children, the incidence rate was 4.05%. 84 of them were mild reaction, 1 moderate reaction and no severe reaction. After vaccination, the positive rate of protective antibody in the population was 100.00%, and the antibody concentration increased from 2.55 IU / L before inoculation to 5 051.90 IU / L after inoculation. The difference was statistically significant (Z = 12.51, P = 0.00) . [Conclusion] The recombinant hepatitis B vaccine of Hansenula was used to enhance the immunity of school-age children with good safety and good immune effect.