Abstract: Abstract: Objective To study the effect of laboratory mice infected with MNV on the evaluation of the titer of hepatitis B vaccine. Method The BALB / c mice were divided into control and infection groups. The infected group was orally administered MNV and the control group was orally administered with saline. According to the Chinese Pharmacopoeia 2015 Part Ⅲ Hepatitis B vaccine titer determination method, hepatitis B vaccine was divided into high, medium and low dose groups and immunized the control group and the infected group mice respectively. Blood was collected on day 7, 14, 21, 28, and 35 after immunization to determine the hepatitis B surface antibody ( HbsAb ) . The ED50 values at each time point of immunization of the control group and the infection group were calculated and compared. Chi-square test was used to compare the difference of HbsAb positive rate between the control group and the infected group. Result The ED50 values of the control group immunized with hepatitis B vaccine on day 14, 21, 28, and 35 were 0. 55, 0. 55, 0. 28, and 0. 24 μg / mL, and those in the infected group were 0. 90, 0. 54, 0. 32, and 0. 32 μg / mL, respectively. On the day 21, the ED50 values of the two groups were close, and the ED50 values of the control group at the remaining three time points were lower than those of the infected group. After chi-square test, there was no significant difference in the overall positive rate of HbsAb between the control group and the infected group at all time points ( P > 0. 05) . Further comparison revealed that on the day 28 and day 35 of immunization with hepatitis B vaccine, the number of animals with HbsAb immunized with high-dose hepatitis B vaccine in the control group was significantly higher than that in the infected group ( P < 0. 05 ) ; On the day 14 after immunization, the number of HbsAb-positive animals immunized with the middle-dose hepatitis B vaccine in the control group was significantly higher than that in the infection group ( P<0. 05) . Conclusion To determine the hepatitis B vaccine titer using MNV-positive mice will result in lower result.

Key words: Key words:MNV, hepatitis B vaccine, vaccine titer determination

摘要： 摘要:目的 研究小鼠诺如病毒( murine norovirus,MNV) 感染实验小鼠对乙肝疫苗效价评价的影响。 方法 将BALB / c 小鼠分为对照组和感染组,感染组经口灌胃 MNV,对照组灌胃生理盐水,参照《中国药典》2015 年第三部乙肝疫苗效价测定方法,将乙肝疫苗分为高、中、低 3 个剂量组,分别免疫对照组和感染组小鼠,于免疫后第 7、14、21、28、35 天采血,测定乙肝表面抗体( HbsAb) ,计算并比较对照组和感染组小鼠在免疫各时间点的疫苗半数动物有效剂量( ED50 ) ,卡方检验比较对照组和感染组小鼠 HbsAb 阳性率差异。 结果 对照组小鼠免疫乙肝疫苗第 14、21、28、35 天计算所测得 ED50 值分别为 0. 55、0. 55、0. 28、0. 24 μg / mL,感染组分别为 0. 90、0. 54、0. 32、0. 32 μg / mL,除了第 21 天两组 ED50 值接近,其余 3 个时间点对照组 ED50 值均低于感染组;经卡方检验,对照组和感染组免疫所有时间点 HbsAb 总体阳性率无显著差异( P>0. 05) 。 进一步比较,乙肝疫苗免疫第 28 天及第 35 天,对照组小鼠免疫高剂量乙肝疫苗产生 HbsAb 的动物数量显著高于感染组( P< 0. 05) ;免疫第 14 天,对照组小鼠免疫中剂量乙肝疫苗产生 HbsAb 的动物数量相比感染组有显著提高( P< 0. 05) 。 结论 使用 MNV 阳性小鼠测定乙肝疫苗效价会致结果偏低。

关键词: 关键词:小鼠诺如病毒, 乙肝疫苗, 疫苗效价测定