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目的探讨甲公司研制的吸附无细胞百白破联合疫苗(甲疫苗)与乙公司研制的无细胞百白破联合疫苗(乙疫苗)应用于3～5月龄儿童的免疫原性。方法在江苏省赣榆县青口镇随机选择3～5月龄未接种过百白破联合疫苗的健康儿童进行基础免疫全程接种。本实验共收集甲疫苗组308例,乙疫苗组193例。甲疫苗组在接种前后采集血清样本,采用ELISA方法分别检测破伤风抗体(T)、白喉抗体(D)、百日咳毒素抗体(PT)和丝状血凝素抗体(FHA)。乙疫苗组则在接种后采用ELISA方法检测上述4种抗体。结果甲疫苗组和乙疫苗组上述4种抗体阳转率差异无统计学意义(P>0.05)。甲疫苗免疫前后4种抗体GMT水平差异有统计学意义(P<0.05),接种后水平显著高于接种前。结论甲公司研制的吸附无细胞百白破联合疫苗接种后有良好的免疫原性。
OBJECTIVE To investigate the immunogenicity of A cell-free diphtheriae combined vaccine (A vaccine) developed by Company A and the cell-free baibutang combination vaccine (B vaccine) developed by Company B in children aged 3 to 5 months. Methods Qingkou Town, Ganyu County, Jiangsu Province, randomly selected healthy children aged 3 to 5 months who had not been vaccinated with diphtheria combined vaccine for full vaccination. A total of 308 cases of A vaccine group collected in this experiment, B vaccine 193 cases. Serum samples were collected before and after vaccination in group A, and tetanus antibody, diphtheria antibody, pertussis toxin antibody and FHA were detected by ELISA. In the second group, the above four antibodies were detected by ELISA after inoculation. Results There was no significant difference in the positive rate of the four antibodies between the A and B vaccine groups (P> 0.05). The differences of GMT levels of four antibodies before and after vaccine A were statistically significant (P <0.05), and the levels of GMT after vaccination were significantly higher than those before vaccination. Conclusion A company developed adsorption cell-free combination of baicalin vaccination has good immunogenicity.