Zhang Zhilun, Zhu Xiangjun, Hu Yuansheng, Liang Miao, Sun Jin, Song Yufei, Yang Qi, Ji Haiquan, Zeng Gang, Song Lifei, Chen Jiangting
a Tianjin Center for Disease Control and Prevention , Tianjin , China.
b Sinovac Biotech Co., LTD. , Beijing , China.
Hum Vaccin Immunother. 2017 Jun 3;13(6):1-6. doi: 10.1080/21645515.2016.1278329. Epub 2017 Feb 14.
In China, both inactivated hepatitis A (HA) vaccine and live attenuated HA vaccine are available. We conducted a trial to evaluate 5-year immune persistence induced by one dose of inactivated or live attenuated HA vaccines in children. Subjects with no HA vaccination history had randomly received one dose of inactivated or live attenuated HA vaccine at 18-60 months of age. Anti-HAV antibody concentrations were measured before vaccination and at the first, second, and fifth year after vaccination. Suspected cases of hepatitis A were monitored during the study period. A total of 332 subjects were enrolled and 182 provided evaluable serum samples at all planned time points. seropositive rate at 5 y was 85.9% in the inactivated HA vaccine group and 90.7% in the live attenuated HA vaccine group. GMCs were 76.3% mIU/ml (95% CI: 61.7 - 94.4) and 66.8mIU/ml (95% CI: 57.8 - 77.3), respectively. No significant difference in antibody persistence between 2 groups was found. No clinical hepatitis A case was reported. A single dose of an inactivated or live attenuated HA vaccine at 18-60 months of age resulted in high HAV seropositive rate and anti-HAV antibody concentrations that lasted for at least 5 y.
在中国,甲型肝炎(HA)灭活疫苗和减毒活疫苗均有供应。我们开展了一项试验,以评估一剂甲型肝炎灭活疫苗或减毒活疫苗在儿童中诱导的5年免疫持久性。无甲型肝炎疫苗接种史的受试者在18至60月龄时随机接种一剂甲型肝炎灭活疫苗或减毒活疫苗。在接种疫苗前以及接种后第1年、第2年和第5年测量抗甲型肝炎病毒(HAV)抗体浓度。在研究期间监测甲型肝炎疑似病例。共纳入332名受试者,其中182名在所有计划时间点提供了可评估的血清样本。灭活甲型肝炎疫苗组5年时的血清阳性率为85.9%,减毒活甲型肝炎疫苗组为90.7%。几何平均浓度(GMC)分别为76.3 mIU/ml(95%置信区间:61.7 - 94.4)和66.8 mIU/ml(95%置信区间:57.8 - 77.3)。两组之间的抗体持久性无显著差异。未报告临床甲型肝炎病例。18至60月龄时接种一剂甲型肝炎灭活疫苗或减毒活疫苗可导致较高的甲型肝炎病毒血清阳性率和抗甲型肝炎病毒抗体浓度,且该浓度至少持续5年。