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目的验证新车间生产的不同批次乙型脑炎减毒活疫苗免疫原性的批间一致性及其对旧生产车间产品的非劣效性。方法在安徽省合肥市及马鞍山市招募1 723名未接种过乙脑疫苗,无乙型脑炎病史的8~12月龄儿童,随机、双盲法分为4组,分别接种旧生产车间生产的1批及新车间的3批乙型脑炎减毒活疫苗。采集免疫前及免疫后28 d的静脉血,分离血清,采用50%噬斑减少中和抗体试验法检测血清中抗乙型脑炎病毒中和抗体效价,比较不同批次及不同车间生产的疫苗的血清保护率,并对其免疫原性的等效性及非劣效性进行统计学分析,同时评价其安全性。结果 4批疫苗的抗乙脑中和抗体血清保护率为90.14%~92.93%,抗乙型脑炎病毒中和抗体效价的GMT为142.40~191.07,新车间生产的3批疫苗两两比较血清保护率差异的95%可信区间的上、下限均在预设的±10%区间内,新车间生产的疫苗总血清保护率与旧车间生产的疫苗的差异区间下限不超过-10%。4批疫苗的安全性均良好。结论新车间生产的不同批次乙型脑炎减毒活疫苗免疫原性具有良好的批间一致性,且新车间生产的疫苗对旧车间生产的疫苗具有非劣效性。
Objective To verify the consistency of the immunogenicity of different batches of live attenuated encephalitis B vaccine produced in the new plant and their non-inferiority to the old production plant products. Methods A total of 1 723 children aged 8-12 months who were not vaccinated with Japanese encephalitis and without encephalitis were enrolled in Hefei City and Ma’anshan City, Anhui Province. They were randomized and double-blindly divided into 4 groups and inoculated respectively with the old production workshop Batch of 3 batches of new batches of live attenuated encephalitis B vaccine. Serum samples were collected before immunization and 28 days after immunization, serum was separated, neutralizing antibody titer of anti-Japanese encephalitis virus in serum was tested by 50% plaque reduction neutralizing antibody test, Vaccine serum protection rate, and its immunogenicity of the equivalent and non-inferiority of statistical analysis, and evaluate its safety. Results The serum protection rates of anti-Japanese encephalitis neutralizing antibody against four batches of vaccines were 90.14% -92.93%. The GMT of anti-Japanese encephalitis virus neutralizing antibody titers was 142.40-191.07. Three batches of vaccines produced by the new plant were compared with each other serum The upper and lower limits of the 95% confidence interval for the difference in protection rates are all within the preset ± 10% range. The lower limit of the difference between the total serum protection rate of the vaccine produced by the new workshop and the vaccine produced by the old workshop does not exceed -10%. The safety of the four batches of vaccines is good. Conclusion The immunogenicity of live attenuated JE vaccine from batches of different batches produced by the new plant has good inter-batch consistency and the vaccine produced by the new plant has non-inferiority to the vaccine produced by the old plant.