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目的评价≥16岁正常人群接种60μg重组乙型病毒性肝炎(乙肝)疫苗(酿酒酵母)的安全性和免疫原性。方法对纳入的4 345名(包括3 415名初免人群和930名常规免疫无应答人群)≥16岁正常人群接种60μg重组乙肝疫苗(酿酒酵母),观察所有受试者疫苗接种后0~28 d内出现的不良反应;检测930名常规免疫无应答人群接种前和接种后1个月后乙肝病毒表面抗体(抗-HBs),分析抗体阳转率和几何平均滴度(GMT)。结果4 345人均完成接种,712人发生不良反应,不良反应发生率为16.39%,其中局部不良反应657人,发生率为15.12%;全身不良反应176人,发生率为4.05%,以1级不良反应为主,未见有临床意义的严重不良事件。930名常规接种无应答者抗-HBs阳转率为87.03%(718/825),其中应答反应活跃者占76.74%(551/718),抗-HBs水平为479.28 m IU/mL。不同性别和年龄组间抗-HBs阳转率差异无统计学意义(P>0.05)。女性抗-HBs GMT高于男性(P<0.05),不同年龄组抗-HBs GMT差异无统计学意义(P>0.05)。结论 60μg重组乙肝疫苗(酿酒酵母)用于≥16岁正常人群具有良好的安全性;对乙肝疫苗基础免疫失败人群接种,同样能够产生良好的免疫效果。
Objective To evaluate the safety and immunogenicity of 60 μg recombinant hepatitis B vaccine (Saccharomyces cerevisiae) in ≥16 years old normal population. Methods A total of 4 345 (including 3 415 initial immunizations and 930 routine immunocompromised) and 60 ug recombinant hepatitis B vaccines (Saccharomyces cerevisiae) were enrolled in this study. All subjects were vaccinated with 0 to 28 d). Antibody-HBs (anti-HBs) were measured before and after 1 month of inoculation in 930 non-responders. The antibody positive rate and geometric mean titer (GMT) were analyzed. Results A total of 4 345 people were vaccinated and 712 people had adverse reactions. The incidence of adverse reactions was 16.39%, of which 657 were local adverse reactions, with a rate of 15.12%. There were 176 systemic adverse reactions with a rate of 4.05% Reaction-based, no clinically significant serious adverse events. The anti-HBs positive rate was 87.03% (718/825) in 930 regular non-responders, of which 76.74% (551/718) were active responders and 479.28 m IU / mL anti-HBs. There was no significant difference in anti-HBs positive rate among different sexes and age groups (P> 0.05). The anti-HBs in women was higher than that in men (P <0.05). The GMTs of anti-HBs in different age groups had no significant difference (P> 0.05). Conclusion 60μg recombinant hepatitis B vaccine (Saccharomyces cerevisiae) is of good safety for normal population of ≥16 years of age. Inoculation of hepatitis B vaccine with basic immune failure can also produce good immune effect.