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目的:观察新型冠状病毒疫苗加强免疫的免疫原性及安全性。方法:2020年10月，江苏省疾病预防控制中心（CDC）开展了新型冠状病毒灭活疫苗的Ⅱ期临床试验，入组对象为18~59岁、未妊娠、未哺乳的健康人群，基础免疫程序为0-14 d 5 μg、0-14 d 10 μg、0-28 d 5 μg、0-28 d 10 μg，从其中按研究编号从小到大顺序各选择50名（共200名）完成2剂基础免疫的受试者，在完成基础免疫后第6个月（窗口期30 d）加强接种第3剂与基础免疫同样剂量的疫苗。加强免疫前后分别采集静脉血约5 ml，分析活病毒中和抗体、假病毒中和抗体、受体结合域IgG抗体（RBD-IgG）的阳转率和几何平均滴度（GMT）。收集并分析加强免疫后28 d内不良事件发生情况。结果:0-14 d 5 μg、0-14 d 10 μg、0-28 d 5 μg、0-28 d 10 μg组对象的基线年龄分别为（43.98±9.58）、（43.46±9.34）、（42.56±9.08）和（43.94±11.05）岁（n P=0.877），各组间性别比例均衡（n P=0.331）；4组活病毒中和抗体GMT（95%n CI）由加强免疫前的4.07（3.30~5.04）、3.75（3.08~4.55）、8.33（7.01~11.11）和7.69（6.19~9.57）升至加强免疫后28 d的284.84（215.28~376.86）、233.05（178.61~304.08）、274.81（223.64~337.68）和280.77（234.59~336.04），抗体阳转率均为100%。4组的加强免疫后28 d内不良事件发生率分别为18.0%（9例）、4.0%（2例）、12.0%（6例）和12.0%（6例）（n P=0.182），无3级及以上不良事件、无严重不良事件。n 结论:新型冠状病毒灭活疫苗基础免疫6个月后进行1剂加强免疫具有良好的免疫原性和安全性。“,”Objective:To assess the immunogenicity and safety of a booster vaccination with an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine.Methods:The phase Ⅱ trial of an inactivated SARS-CoV-2 vaccine was conducted by Jiangsu Provincial Center for Disease Control and Prevention (CDC) since October 2020. The subjects were healthy adults aged 18-59 years, excluding pregnant, and not breastfeeding women. The primary vaccination schedule groups were 0-14 d 5 μg, 0-14 d 10 μg, 0-28 d 5 μg and 0-28 d 10 μg, respectively. And 50 participants in each group, a total of 200, who have received 2-doses primary vaccination were selected in ascending order of the study number and vaccinated with a booster dose (same dosage as primary vaccination) at the 6th months after post the primary vaccination (30-day window period). Blood samples were collected before and after boosting and tested for the geometric mean titers (GMT) and seroconversion of live virus neutralizing antibody, pseudovirus neutralizing antibody and receptor-binding-domain (RBD) IgG antibody. Adverse events (AE) were collected and assessed within 28 days after boosting.Results:The ages of subjects in group 0-14 d 5 μg, 0-14 d 10 μg, 0-28 d 5 μg and 0-28 d 10 μg were (43.98±9.58), (43.46±9.34), (42.56±9.08) and (43.94±11.05) years old, respectively (n P=0.877). Sex ratios were balanced among the 4 groups (n P=0.331). The live virus neutralizing antibody GMT (95%n CI) in group 0-14 d 5 μg, 0-14 d 10 μg, 0-28 d 5 μg and 0-28 d 10 μg increased from 4.07 (3.30-5.04), 3.75 (3.08-4.55), 8.33 (7.01-11.11) and 7.69 (6.19-9.57) before the booster vaccination to 284.84 (215.28-376.86), 233.05 (178.61-304.08), 274.81 (223.64-337.68) and 280.77 (234.59-336.04) in 28 days after the booster vaccination, respectively. The rates of live virus neutralizing antibody seroconversion were all 100% in the 4 groups. The AE incidences following booster vaccination were 18.0% (9 cases), 4.0% (2 cases), 12% (6 cases), and 12% (6 cases) in the 4 groups(n P=0.182). No AE was graded as level 3 or worse. No serious AE was reported.n Conclusion:One booster vaccination of an inactivated SARS-CoV-2 vaccine administered 6 months after primary vaccination showed good immunogenicity and safety.