我国研制的乙型肝炎基因重组疫苗近期免疫效果观察

目的 考察新生儿接种国产乙型肝炎（乙肝）中仓鼠卵巢细胞（CHO）表达的基因重组疫苗的近期免疫效果。方法 1997年1月1日至1999年8月31日,在河北省正定县选择7个乡,对2969名新生儿按现生后2４h及１、６个月免疫程序接种３剂乙肝ＣＨＯ疫苗,每剂１０μg。每季度对新生儿的乙肝疫苗接种情况进行调查核实。２０００年４月对完成全程免疫的观察对象采集血清,检测ＨＢsAg、抗－ＨＢs和抗－ＨＢc三项乙肝病毒标志。结果 新生儿乙肝疫苗全程接种率为９３.74％（２７８３／２９６９）,第１剂在出生２４h内接种的及时接种率为９５.42%（２８３３／２９６９）。２０００年４月采血率为６８.4%（１９０６／２７８３）。新生儿乙肝ＣＨＯ疫苗全程免疫后第１年内抗－ＨＢs阳性率[样本值／阴性对照值（Ｓ／Ｎ）≥2.1]为９８．２５％,有效抗－ＨＢs阳性率（Ｓ／Ｎ≥10.0）为９４.26%,抗体几何平均滴度（ＧＭＴ）为７７.64;其后抗体水平随时间延长逐渐降低,第３年时抗－ＨＢs阳性率为９２.31%,有效抗－ＨＢs阳转率为６８.96%,ＧＭＴ为２２.86,３年中ＨＢsAg阳性率均小于１％,抗－ＨＢc阳性率和ＨＢＶ感染率在１％－３％之间,未见随年限延长而增加的趋势。结论 国产乙肝ＣＨＯ疫苗的免疫原性和近期保护效果良好。

Immediate immunological effect of China-made recombinant hepatitis B vaccine expressed by transgenic Chinese hamster ovary cell line

OBJECTIVE: To understand the protective efficacy of China-made recombinant hepatitis B vaccine expressed by transgenic Chinese hamster ovary cell line among newborns. METHODS: 2 969 newborns in seven townships in Zhengding County, Hebei Province, were vaccinated with 10 microgram x 3 doses of China-made recombinant hepatitis B vaccine expressed by transgenic Chinese hamster ovary cell line according to the 0 - 1 - 6 month schedule from 1 January 1997 to 31 August 1999. The newborns were to be vaccinated with the first dose within 24 hours after they were born. 1906 serum samples were selected in April 2000 to detect the hepatitis B infection markers, including HBsAg, HBsAb and HbcAb by RIA kits. RESULTS: 2 783 of the 2 969 newborns (93.74%) were vaccinated with three doses, 2 833 of them (95.42%) were vaccinated with the first dose within 24 hours after they were born. The anti-HBs positive rate was 98.25% (S/N >/= 2.1) or 94.26% (S/N >/= 10.0), and the geometric mean titer (GMT) value of antibody was 77.64 within the first year after the whole course vaccination. Then the antibody level decreased gradually with the lapse of time. The HBsAb positive rate was 92.31% (S/N >/= 2.1) or 68.96% (S/N >/= 10.0), and GMT value was 22.86 within the third year after vaccination. The HBsAg positive rates remained less than 1%, the HBcAb positive rates and HBV infection rates remained 1% approximately 3% within 3 years after vaccination. CONCLUSION: The protective efficacy of China-made recombinant hepatitis B vaccine is satisfactory.