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目的 考察新生儿接种国产乙型肝炎 (乙肝 )中国仓鼠卵巢细胞 (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2 96 9名新生儿按出生后 2 4h及 1、6个月免疫程序接种 3剂乙肝CHO疫苗 ,每剂 10 μg。每季度对新生儿的乙肝疫苗接种情况进行调查核实。 2 0 0 0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 % (2 783/2 96 9) ,第 1剂在出生 2 4h内接种的及时接种率为 95 4 2 % (2 833/ 2 96 9)。 2 0 0 0年 4月采血率为6 8 4 % (190 6 / 2 783)。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 2 5 % ,有效抗 HBs阳性率 (S/N≥ 10 0 )为 94 2 6 % ,抗体几何平均滴度 (GMT)为77 6 4 ;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6 8 96 % ,GMT为 2 2 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
Objective To investigate the recent immunization of neonatal vaccination with recombinant hepatitis B virus (HB) gene expressed in Chinese hamster ovary cells (CHO). Methods From January 1, 1997 to August 31, 1999, 7 townships were selected in Zhengding County, Hebei Province, and 3 doses of hepatitis B CHO were given to 2 969 newborns by immunization schedule of 24 hours and 1,6 months after birth Vaccine, 10 μg per dose. Quarterly survey of neonatal hepatitis B vaccination. In April 2000, the subjects who completed the whole immunization were enrolled in the study, and three HBsAg, anti-HBs and anti-HBc HBV markers were detected. Results The overall vaccination rate of newborns with hepatitis B vaccine was 93 74% (2 783/2 96 9). The first vaccination was 95 42% (2 833/2 969) within 24 hours of birth. April 2004 blood collection rate of 684% (190 6/2 783). The positive rate of anti-HBs in the first year after full-fledged immunization of neonatal hepatitis B virus vaccine was 98 2 5% (S / N≥2 1), positive rate of anti-HBs positive (S / N≥10 0) The average antibody titer (GMT) was 77 6 4. The level of anti-HBs was 92 31% at the third year, and the positive rate of anti-HBs was 6 8 96% and GMT 2 2 86. The positive rate of HBsAg in 3 years was less than 1%, the positive rate of anti-HBc and HBV infection rate was between 1% and 3%, but no increase with age. Conclusion The immunogenicity and recent protection of domestic-made CHO vaccine are good