Zhang Yukai, Wang Lei, Wang Yanxia, Zhang Wei, Jia Ningning, Xie Zhiqiang, Huang Lili, You Wangyang, Lu Weifeng, Li Erwei, Gao Feilong, Hu Yuansheng, Meng Fanhong, Xia Shengli
Clinical Laboratory, Jinshui District Center for Disease Control and Prevention, Zhengzhou 450003, China.
Clinical R&D Center, Sinovac Biotech Co., Ltd., Beijing 100085, China.
Vaccines (Basel). 2022 Apr 22;10(5):660. doi: 10.3390/vaccines10050660.
To evaluate the immunogenicity and safety of a booster dose of live attenuated varicella vaccine (VarV) manufactured by Sinovac (Dalian) Vaccine Technology Co. Ltd., and the immune persistence of a primary dose in 2- to 6-year-old children.
A phase IV, open-label study was conducted in China. Children previously vaccinated with a single dose of VarV at 1~3 years old received one dose of homologous VarV in the first year, the second year, or the third year after the primary immunization as booster immunization. Immune persistence was evaluated in an immune persistence analysis set, while immunogenicity was evaluated in a per-protocol analysis set, and safety was evaluated in a safety analysis set. The primary endpoint was the seropositive rate and the seroconversion rate of VarV antibody. The trial was registered at ClinicalTrials.gov (NCT02981836).
From July 2018 to August 2020, a total of 849 vaccinated children received the booster vaccination of VarV, one booster dose for each child (301 vaccinated in the first year after primary immunization (Group 1), 276 vaccinated in the second year after primary immunization (Group 2), 272 vaccinated in the third year after primary immunization (Group 3)). The seropositive rates were 99.34%, 97.83%, and 98.16% in Groups 1-3, with GMTs of 1:22.56, 1:18.49, and 1:18.45, respectively. Thirty days after the vaccine booster dose, the seropositive rates of the three groups were all 100% and the seroconversion rates were 52.54%, 67.46%, and 66.67%, with GMTs of 1:68.49, 1:76.32 and 1:78.34, respectively. The seroconversion rates in Groups 2 and 3 were both higher than that in Group 1 ( = 0.0005 and = 0.0008). The overall incidence of adverse reactions was 7.77%, with 7.64%, 8.33%, and 7.35% in Groups 1, 2, and 3, respectively. The main symptom among adverse reactions was fever, the incidence of which ranged from 5.07% to 6.64% in each group, and no vaccine-related serious adverse events occurred.
VarV had good immune persistence in 13 years after primary immunization. A vaccine booster dose for children aged 13 years after primary immunization recalled specific immune response to varicella-zoster virus, with no safety concerns increased.
评估由北京科兴（大连）疫苗技术有限公司生产的一剂次水痘减毒活疫苗（VarV）加强免疫的免疫原性和安全性，以及首剂在2至6岁儿童中的免疫持久性。
在中国进行了一项IV期开放标签研究。1至3岁时曾接种过一剂次VarV的儿童在初次免疫后的第一年、第二年或第三年接受一剂次同源VarV作为加强免疫。在免疫持久性分析集中评估免疫持久性，在符合方案分析集中评估免疫原性，在安全性分析集中评估安全性。主要终点是VarV抗体的血清阳性率和血清转化率。该试验已在ClinicalTrials.gov注册（NCT02981836）。
从2018年7月至2020年8月，共有849名接种疫苗的儿童接受了VarV加强免疫，每名儿童接种一剂次（初次免疫后第一年接种301名（第1组），初次免疫后第二年接种276名（第2组），初次免疫后第三年接种272名（第3组））。第1至3组的血清阳性率分别为99.34%、97.83%和98.16%，几何平均滴度（GMT）分别为1:22.56、1:18.49和1:18.45。疫苗加强免疫剂量后30天，三组血清阳性率均为100%，血清转化率分别为52.54%、67.46%和66.67%，GMT分别为1:68.49、1:76.32和1:78.34。第2组和第3组的血清转化率均高于第1组（P = 0.0005和P = 0.0008）。不良反应总发生率为7.77%，第1、2、3组分别为7.64%、8.33%和7.35%。不良反应中的主要症状为发热，每组发生率在5.07%至6.64%之间，未发生与疫苗相关的严重不良事件。
VarV在初次免疫后1至3年内具有良好的免疫持久性。1至3岁儿童初次免疫后接种一剂次疫苗加强免疫可唤起对水痘-带状疱疹病毒的特异性免疫反应，且未增加安全性担忧。
