Abstract
刘晓冬,刘海东,熊萍,李珍,李晶,孙建文,曹庆范,张丽,许青.3~11岁儿童接种新型冠状病毒灭活疫苗的免疫原性研究[J].Chinese journal of Epidemiology,2023,44(11):1744-1747
3~11岁儿童接种新型冠状病毒灭活疫苗的免疫原性研究
Immunogenicity of 2019-nCoV inactivated vaccine in children aged 3-11 years
Received:April 07, 2023  
DOI:10.3760/cma.j.cn112338-20230407-00221
KeyWord: 新型冠状病毒灭活疫苗  儿童  免疫原性
English Key Word: 2019-nCoV inactivated vaccine  Children  Immunogenicity
FundProject:山东省医药卫生科技发展计划(202212051006);山东省泰山学者岗位支持项目(Tstp20221164)
Author NameAffiliationE-mail
Liu Xiaodong Shandong Provincial Center for Disease Control and Prevention, Ji'nan 250014, China  
Liu Haidong Rushan County Center for Disease Control and Prevention, Shandong Province, Rushan 264599, China  
Xiong Ping Shandong Provincial Center for Disease Control and Prevention, Ji'nan 250014, China  
Li Zhen Sinovac Life Sciences Co., Ltd., Beijing 102601, China  
Li Jing Sinovac Life Sciences Co., Ltd., Beijing 102601, China  
Sun Jianwen Sinovac Life Sciences Co., Ltd., Beijing 102601, China  
Cao Qingfan Rushan County Center for Disease Control and Prevention, Shandong Province, Rushan 264599, China  
Zhang Li Shandong Provincial Center for Disease Control and Prevention, Ji'nan 250014, China  
Xu Qing Shandong Provincial Center for Disease Control and Prevention, Ji'nan 250014, China xqepi@163.com 
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Abstract:
      目的 评价3~11岁儿童完成新型冠状病毒(新冠病毒)疫苗基础免疫28~42 d后对原始株的免疫原性及与新冠病毒变异株的交叉免疫反应。方法 于2022年1-7月在山东省乳山市招募3~11岁已按照(0,28)d免疫程序完成2剂新冠病毒灭活疫苗基础免疫的受试者,基础免疫后28~42 d采集静脉血3 ml,检测原始株、Beta、Gamma和Delta变异株的中和抗体水平,计算中和抗体阳性率和GMT。结果 纳入免疫原性分析共395人,其中3~5岁组212人,6~11岁组183人。受试者完成基础免疫后28~42 d,血清中对原始株、Beta、Gamma和Delta变异株的中和抗体阳性率分别为100.00%、74.68%、99.24%和97.22%,年龄组间差异无统计学意义(P>0.05)。受试者完成基础疫苗后28~42 d,血清中对原始株、Beta、Gamma和Delta变异株的中和抗体GMT分别为168.19、10.51、53.65和31.10,年龄组间差异无统计学意义(P>0.05)。结论 在3~11岁儿童中接种2剂新冠病毒灭活疫苗的免疫原性良好,可对新冠病毒变异株产生一定的交叉保护。
English Abstract:
      Objective To evaluate the immunogenicity to prototype strain of 2019-nCoV and cross immune response to its variants in children aged 3-11 years after completing the primary immunization of a 2019-nCoV inactivated vaccine for 28-42 days. Methods From January to July 2022, children aged 3-11 years who had been vaccinated with 2019-nCoV inactivated vaccine according to the (0, 28) day immunization schedule were recruited in Rushan, Shandong Province. On 28-42 days after the primary immunization, venous blood samples (3 ml) were collected from them for the detections of the levels of neutralizing antibody to prototype strain, Beta variant, Gamma variant and Delta variant and the neutralizing antibody positive rates and GMTs were calculated. Results A total of 395 children were included in the immunogenicity analysis, including 212 children aged 3-5 years and 183 children aged 6-11 years. The positive rates of neutralizing antibody to prototype strain, Beta, Gamma, and Delta variants on 28-42 days after the primary immunization were 100.00%, 74.68%, 99.24%, and 97.22%, respectively, there were no significant differences between two age groups (P>0.05). On 28-42 days after the primary immunization, the GMTs of neutralizing antibody to prototype strain, Beta, Gamma and Delta variants were 168.19, 10.51, 53.65, and 31.10, respectively, the differences between two age groups were not significant (P>0.05). Conclusion The immunization with 2 doses of 2019-nCoV inactivated vaccine in 3-11 years old children showed good immunogenicity and produced certain cross protection to 2019-nCoV variants.
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