Zhu Fengcai, Huang Ting, Jin Pengfei, Zhang Linglin, Jin Zhongqiang, Zhang Wenli, Yuan Dongya, Wang Zhong, Deng Yusong, Li Jiaxin, Shen Xiao, Fu Yongpan, Li Jian, Yang Xinjie, Li Jing, Xie Liangzhi
Jiangsu Provincial Center for Disease Control and Prevention, Jiangsu Provincial Academy of Preventive Medicine, Nanjing 210009, China.
Sichuan Center for Disease Prevention and Control, Chengdu 610041, China.
Vaccines (Basel). 2025 Jan 7;13(1):43. doi: 10.3390/vaccines13010043.
: SCTV01E is a tetravalent recombinant COVID-19 vaccine authorized for emergency use in China for adults 18 years and older but not for those under 18. : This Phase 2 trial assessed the safety and immunogenicity of SCTV01E in healthy children and adolescents aged 3 to 17 years, to establish immunobridging with that observed in adults from the efficacy pivotal trial (NCT05308576). : Participants were randomly assigned to receive either 30 µg of SCTV01E or a placebo. Primary endpoints were safety and immunogenicity focused on the geometric mean titer (GMT) and seroresponse rate (SRR) of neutralizing antibodies (nAb) against Omicron BA.5. : In total, 268 participants (214 SCTV01E vs. 54 placebo) were included in the safety analysis, with 241 participants (191 vs. 50) in the immunogenicity analysis. Overall, 127 (59.3%) participants receiving SCTV01E and 9 (16.7%) receiving a placebo reported adverse events (AEs), most of which were Grade 1 or 2. No serious adverse events (SAEs) or adverse events of special interest (AESIs) were reported. In the immunogenicity bridging analysis, data from 95 youths were compared with data from 188 adults; the geometric mean ratio (GMR) of the titers was 8.78 (95% CI: 6.05-12.74, < 0.001), with the lower bound of the 95% CI exceeding 0.67. The difference in the SRR was 6.34% (95% CI: 0.93-11.22%) ( = 0.029), and the lower bound of the 95%CI was >-5%, indicating superiority. : SCTV01E was found to be safe and well tolerated in children and adolescents, generating a robust immune response against Omicron BA.5. This supports its potential use in younger populations.
SCTV01E是一种四价重组新冠病毒疫苗，在中国被批准用于18岁及以上成年人的紧急使用，但不适用于18岁以下人群。本2期试验评估了SCTV01E在3至17岁健康儿童和青少年中的安全性和免疫原性，以建立与疗效关键试验（NCT05308576）中成年人观察结果的免疫桥接。参与者被随机分配接受30μg的SCTV01E或安慰剂。主要终点是安全性和免疫原性，重点是针对奥密克戎BA.5的中和抗体（nAb）的几何平均滴度（GMT）和血清反应率（SRR）。总共268名参与者（214名接受SCTV01E，54名接受安慰剂）纳入安全性分析，241名参与者（191名 vs. 50名）纳入免疫原性分析。总体而言，127名（59.3%）接受SCTV01E的参与者和9名（16.7%）接受安慰剂的参与者报告了不良事件（AE），大多数为1级或2级。未报告严重不良事件（SAE）或特别关注的不良事件（AESI）。在免疫原性桥接分析中，将95名年轻人的数据与188名成年人的数据进行了比较；滴度的几何平均比（GMR）为8.78（95%CI：6.05 - 12.74，<0.001），95%CI的下限超过0.67。SRR的差异为6.34%（95%CI：0.93 - 11.22%）（P = 0.029），95%CI的下限>-5%，表明具有优越性。研究发现SCTV01E在儿童和青少年中安全且耐受性良好，可产生针对奥密克戎BA.5的强大免疫反应。这支持了其在年轻人群中的潜在应用。
