Yao D Y, Chen Y P, Ding F, Hu X S, Liang Z Z, Xing B, Cao Y F, Zhang T Q, Wang X L, Liao Y T, Yang J, Lyu H K
School of Public Health, Hangzhou Normal University, Hangzhou 311121, China.
Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2024 Jan 6;58(1):25-32. doi: 10.3760/cma.j.cn112150-20230423-00317.
To evaluate the immunogenicity, safety, and immune persistence of the sequential booster with the recombinant protein-based COVID-19 vaccine (CHO cell) in healthy people aged 18-84 years. An open-label, multi-center trial was conducted in October 2021. The eligible healthy individuals, aged 18-84 years who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, were recruited from Shangyu district of Shaoxing and Kaihua county of Quzhou, Zhejiang province. All participants were divided into three groups based on the differences in prime-boost intervals: Group A (3-4 months), Group B (5-6 months) and Group C (7-9 months), with 320 persons per group. All participants received the recombinant COVID-19 vaccine (CHO cell). Blood samples were collected before the vaccination and after receiving the booster at 14 days, 30 days, and 180 days for analysis of GMTs, antibody positivity rates, and seroconversion rates. All adverse events were collected within one month and serious adverse events were collected within six months. The incidences of adverse reactions were analyzed after the booster. The age of 960 participants was (52.3±11.5) years old, and 47.4% were males (455). The GMTs of Groups B and C were 65.26 (54.51-78.12) and 60.97 (50.61-73.45) at 14 days after the booster, both higher than Group A's 44.79 (36.94-54.30) ( value<0.05). The GMTs of Groups B and C were 23.95 (20.18-28.42) and 27.98 (23.45-33.39) at 30 days after the booster, both higher than Group A's 15.71 (13.24-18.63) ( value <0.05). At 14 days after the booster, the antibody positivity rates in Groups A, B, and C were 91.69% (276/301), 94.38% (302/320), and 93.95% (295/314), respectively. The seroconversion rates in the three groups were 90.37% (272/301), 93.75% (300/320), and 93.31% (293/314), respectively. There was no significant difference among these rates in the three groups (all values >0.05). At 30 days after the booster, antibody positivity rates in Groups A, B, and C were 79.60% (238/299), 87.74% (279/318), and 90.48% (285/315), respectively. The seroconversion rates in the three groups were 76.92% (230/299), 85.85% (273/318), and 88.25% (278/315), respectively. There was a significant difference among these rates in the three groups (all values <0.001). During the sequential booster immunization, the incidence of adverse events in 960 participants was 15.31% (147/960), with rates of about 14.38% (46/320), 17.50% (56/320), and 14.06% (45/320) in Groups A, B, and C, respectively. The incidence of adverse reactions was 8.02% (77/960), with rates of about 7.50% (24/320), 6.88% (22/320), and 9.69% (31/320) in Groups A, B, and C, respectively. No serious adverse events related to the booster were reported. Healthy individuals aged 18-84 years, who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, have good immunogenicity and safety profiles following the sequential booster with the recombinant COVID-19 vaccine (CHO cell).
评估重组蛋白新冠病毒疫苗（CHO细胞）序贯加强免疫在18-84岁健康人群中的免疫原性、安全性和免疫持久性。2021年10月开展了一项开放标签、多中心试验。从浙江省绍兴市上虞区和衢州市开化县招募符合条件的健康个体，年龄在18-84岁，在3至9个月前已完成新冠病毒灭活疫苗基础免疫。所有参与者根据基础免疫与加强免疫间隔的差异分为三组：A组（3-4个月）、B组（5-6个月）和C组（7-9个月），每组320人。所有参与者均接种重组新冠病毒疫苗（CHO细胞）。在接种前以及接种加强针后14天、30天和180天采集血样，分析几何平均滴度（GMT）、抗体阳性率和血清转化率。在1个月内收集所有不良事件，在6个月内收集严重不良事件。加强免疫后分析不良反应的发生率。960名参与者的年龄为（52.3±11.5）岁，男性占47.4%（455人）。加强免疫后14天，B组和C组的GMT分别为65.26（54.51-78.12）和60.97（50.61-73.45），均高于A组的44.79（36.94-54.30）（P值<0.05）。加强免疫后30天，B组和C组的GMT分别为23.95（20.18-28.42）和27.98（23.45-33.39），均高于A组的15.71（13.24-18.63）（P值<0.05）。加强免疫后14天，A组、B组和C组的抗体阳性率分别为91.69%（276/301）、94.38%（302/320）和93.95%（295/314）。三组的血清转化率分别为90.37%（272/301）、93.75%（300/320）和93.31%（293/314）。三组的这些率之间无显著差异（所有P值>0.05）。加强免疫后30天，A组、B组和C组的抗体阳性率分别为79.60%（238/299）、87.74%（279/318）和90.48%（285/315）。三组的血清转化率分别为76.92%（230/299）、85.85%（273/318）和88.25%（278/315）。三组的这些率之间存在显著差异（所有P值<0.001）。在序贯加强免疫期间，960名参与者的不良事件发生率为15.31%（147/960），A组、B组和C组的发生率分别约为14.38%（46/320）、17.50%（56/320）和14.06%（45/320）。不良反应发生率为8.02%（77/960），A组、B组和C组的发生率分别约为7.50%（24/320）、6.88%（22/320）和9.69%（31/320）。未报告与加强针相关的严重不良事件。3至9个月前已完成新冠病毒灭活疫苗基础免疫的18-84岁健康个体，在接种重组新冠病毒疫苗（CHO细胞）序贯加强免疫后具有良好的免疫原性和安全性。
