16岁及以上人群接种60μg重组乙肝疫苗安全性及免疫原性研究

Safety and immunogenicity evaluation of 60 μg recombinant hepatitis B vaccine(Saccharomyces Cerecisiae) in population aged 16 and above

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 of 60 μg recombinant hepatitis B vaccine（Saccharomyces Cerecisiae） in healthy population over 16 years old and immunogenicity in non-responders.Methods A total of 4 345 eligible subjects over 16 years old were selected and vaccinated with 60 μg recombinant hepatitis B vaccine,including 3 415 participants who have never been vaccined before and 930 non-responders.All participants were monitored for any adverse events occurring within 30 min after each injection and instructed to record selected injection-site reactions and systemic reactions on the day of vaccination and the subsequent 28 days.Blood samples were collected from non-responders at pre-vaccination and one month after vaccination,in order to determine anti-HBs levels,positive rates of anti-HBs and the mean geometric titre（GMT） of anti-HBs.Results Among 4 345 vaccinated participants,16.39 % of them reported at least one injection-site or systemic adverse reaction.The most common injection-site and systemic adverse reactions were Grade 1 adverse reactions with the incidence of 15.12 %（657/4 345） and 4.05%（176/4 345） respectively.No serious adverse events were observed.Among 930 non-responders,the positive rate of anti-HBs was 87.03 % with active responder of 76.74 %（551/718） and the GMT of anti-HBs was 479.28 m IU/ml.The positive rate of anti-HBs was not associated with gender or age（P0.05）.The GMT of anti-HBs demonstrated significant differences between female and male（560.66 m IU/mL VS.404.91 m IU/mL,P0.05）,but there was no significant differences in different age groups（P0.05）.Conclusion 60 μg recombinant hepatitis B vaccine was safe for healthy adults above 16 years and had good immunity efficacy among non-responders who had no or low response to standard immunization regimen of hepatitis B vaccine.