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通过临床研究确定冻干水痘减毒活疫苗的最小免疫剂量 ,为制定规程中的免疫剂量提供科学依据。观察对象接种不同免疫剂量的冻干水痘减毒活疫苗后 ,于接种前和接种后 6周采血 ,采用荧光抗膜抗体 (FAMA)法检测其抗体阳转率和几何平均滴度 (GMT)。接种不同免疫剂量的疫苗 ,抗体阳转率差异无显著的统计学意义。疫苗中抗原含量在 2 5 0 0 0PFU/ml和 2 0 0 0PFU/ml之间 ,GMT差异无显著的统计学意义 ,但 2 5 0 0 0PFU/ml、2 0 0 0PFU/ml与 2 0 0PFU/ml之间抗体GMT的差异有极显著的统计学意义。研究结果表明 ,2 0 0 0PFU/ml为冻干水痘减毒活疫苗的最小免疫剂量。
Through clinical research to determine the minimum immunization dose of live attenuated freeze-dried varicella vaccine, to provide a scientific basis for the formulation of immunization doses. Observed subjects were vaccinated with different doses of lyophilized varicella zoster vaccine, before vaccination and 6 weeks after inoculation, blood was collected and the antibody positive rate and geometric mean titer (GMT) were measured by fluorescent anti-membrane antibody (FAMA) method. Vaccination with different doses of vaccines, antibody positive rate difference was not statistically significant. The antigen content in the vaccine was between 2500 PFU / ml and 2000 PFU / ml, with no significant difference in GMT. However, the amount of antigens in the vaccine was 2500 pFU / ml, 200 pFU / ml and 200 pFu / ml antibody GMT differences between the extremely significant statistical significance. The results show that 20 000 PFU / ml is the minimum immunization dose of live attenuated freeze-dried varicella vaccine.