10μg重组乙型肝炎疫苗(酵母)扩大适用人群安全性和免疫原性研究

目的 评价10μg重组乙型肝炎疫苗(酵母)扩大适用人群至5～18岁的可行性.方法 筛选乙肝表面抗原(HBsAg)及表面抗体(抗-HBs)均阴性者,进行两个阶段的临床试验,对安全性和免疫原性观察分析.对925名受试者进行了安全性观察;在免疫原性观察中共检测568名受试者,包括观察组(5～18岁)493名、对照组(>18岁)75名,观察组又分为3个亚组:儿童组(5～6岁)141名、少年组(12～13岁)177名、青年组(16～18岁)175名.使用10μg重组乙型肝炎疫苗(酵母)按0、1、6个月程序接种3针,分时段连续观察4周并记录其接种反应以评价疫苗安全性,全程接种后4～6周时用固相放射免疫(RIA)法共检测568份有效血清,比较两组抗-HBs阳转率、几何平均滴度(GMT)和达到保护水平率以评价疫苗免疫原性.结果 观察组和对照组在接种疫苗后0.5、6、24、48、72 h及1周、2周、3周、4周均未观察到局部或全身的异常反应.免疫后儿童组、少年组、青年组和对照组抗-HBs阳转率分别为100.00%(141/141)、97.18%(172/177)、98.29%(172/175)和89.33%(67/75),GMT分别为440.28、875.38、467.80、131.06 U/L,达到保护水平率分别为100.00%(141/141)、97.18%(172/177/)、97.14%(170/175)和86.67%(65/75).观察组的3个亚组抗-HBs阳转率、GMT、达到保护水平率均高于对照组(x_(阳转率)~2=12.77、5.12、7.99;t_(GMT)=3.89、4.13、5.91;x_(保护率)~2=16.81、8.60、8.44;P值均<0.05).结论 试验疫苗在5～18岁人群接种安全有效,抗-HBs阳转率和保护率高于18岁以上人群.     

The immunogenicity and safety of 10 μg recombination yeast hepatitis B vaccine applied in expanded population

Objective To assess the feasibility of the 10 μg recombination yeast hepatitis B vaccine in the expanded applicable population group aged 5-18. Methods People with both HBsAg and anti-HBs negative were selected to take two-stage clinical experiment and the safety and immunogenicity were observed. Safety observation was conducted in 925 subjects, while 568 for immunogenicity. The observation group (aged 5-18) included 493 subjects, and (age>18) 75 enrolled in control group. For the observation group,there were three sub-groups including a child group (141, aged 5-6), early youth group(177, aged 12-13), and youth group (175, aged 16-18). Both groups were administered with 10 μg recombination yeast hepatitis B vaccines with 3 doses at 0 month, 1st month,6th month. To assess the immunogenicity,the vaccination reactions were observed during the following 4 weeks in order to assess the vaccine safety. The blood samples were taken during 4-6 weeks after fully vaccinated, and then anti-HBs were tested with RIA and analyzed by comparing the positive rate of anti-HBs,the geometric mean titer(GMT) and the protective rate between the two groups. Results Both observation and control group didn't show any general reactions,adverse events following immunization(AEFI) or coincidental cases when observed at 0. 5 h,6 h,24 h,48 h, 72 h, 1 week,2 weeks,3 weeks,4 weeks after being vaccinated. The result of serum test showed, the positive rates of child group, early youth group, youth group and control group were respectively 100. 00% (141/ 141),97.18% (172/177), 98. 29% (172/175) and 89. 33% (67/75); the GMTs of anti-HBs were respectively 440. 28,875.38,467.80,131.06 U/L; the protective rates were respectively 100. 00% (141/ 141), 97.18%(172/177), 97.14% (170/175) and 86. 67% (65/75). The positive rate, GMT and protective rate of the experimental group were all higher than that of control group(χ2<,positive rate>=12.77,5.12, 7.99; tGMT=3.89,4.13,5.91;χ2protective rate>=16. 81,8.60,8.44;P< 0.05). Conclusion This vaccine could be expanded to 5-18 year-old population with safety and effectiveness, the positive rate and protective rate of anti-HBs were both higher than that of control group.