国产重组酵母乙型肝炎疫苗接种小学生的3年免疫效果观察

Three years follow up study for the children immunized with Yeast derived hepatitis B vaccines(YDV)

本文报告对２５８ 名小学生应用０、１、６ 月程序，接种２ 批国产酵母疫苗（５ μｇ／０．５ ｍ ｌ），１ 批Ａｍ ｇｅｎ 酵母疫苗（１０ μｇ／ｍ ｌ），１ 批Ｍ ＳＤ 酵母疫苗（５ μｇ／０．５ ｍ ｌ）的小学生免后３ 年（（Ｔ３６）效果观察。结果表明，Ｔ３６ 时抗体 ＧＭＴ（几何平均滴度），Ａｍ ｇｅｎ 疫苗组（１４５．７５）显著高于 ２ 批国产疫苗（９２．１１、８３．５２）和Ｍ．Ｓ．Ｄ 苗组（７４．６２），抗体ＧＭＴ 峰值显著低于Ａｍ ｇｅｎ 和Ｍ ．Ｓ．Ｄ 苗的２ 批国产酵母疫苗，与Ｍ．Ｓ．Ｄ 苗抗体ＧＭＴ 水平无显著差异（Ｐ＞ ０．０５）。抗体阳转率间各疫苗组均无显著差异（９３．１０％ ～７４．１４％ ）。本次随访结果表明，采用０，１，６ 免疫程序，国产酵母疫苗免后３ 年的抗体阳转率和抗体ＧＭＴ水平不低于进口同类酵母疫苗的水平。

children aged 6 to 12 years were randomly divided into 4 groups,2 groups were immunized with CYDV(produced by National Vaccine and Serum Institute,5 μg/dose,9312623,9312645),1 group with AYDV(produced by Amgen Company,10 μg/dose) and lgroup with MYDV(produced by merck company, 5μg/dose) administered at 0 1 and 6 months were follow up for three years(T36).The result showed that at T36,the anti HBs geometric mean titre(GMT) of AYDV group was significantly higner than other three groups(145.75,92.11,83.52,74.62).The antibody GMTs of 2 CYDV groups was similar with that of MYDV group(P>0.05)despite the peak of GMTs of 2 CYDV groups was significantly lower than that of MYDV groups and AYDV.The anti HBs positive rates were 93.10%,92.11%,78.05%and 74.14%,respectively,for AYDV,9312623,MYDV and 9312645 group,but no significant difference was observed(P>0.05).It is conclude that for the children immunized by 0,1,6 schedule,that the antibody positive rate and antibody GMT was similar with that of MYDV.