Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial
<b>Background</b>: 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. <b>Objective</b>: This Phase 2 trial assessed the safety and immunogenicity of SCTV01E in healthy children...
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2025-01-01
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| Online Access: | https://www.mdpi.com/2076-393X/13/1/43 |
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| author | Fengcai Zhu Ting Huang Pengfei Jin Linglin Zhang Zhongqiang Jin Wenli Zhang Dongya Yuan Zhong Wang Yusong Deng Jiaxin Li Xiao Shen Yongpan Fu Jian Li Xinjie Yang Jing Li Liangzhi Xie |
| author_facet | Fengcai Zhu Ting Huang Pengfei Jin Linglin Zhang Zhongqiang Jin Wenli Zhang Dongya Yuan Zhong Wang Yusong Deng Jiaxin Li Xiao Shen Yongpan Fu Jian Li Xinjie Yang Jing Li Liangzhi Xie |
| author_sort | Fengcai Zhu |
| collection | DOAJ |
| description | <b>Background</b>: 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. <b>Objective</b>: 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). <b>Methods</b>: 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. <b>Results</b>: 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, <i>p</i> < 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%) (<i>p</i> = 0.029), and the lower bound of the 95%CI was >−5%, indicating superiority. <b>Conclusions</b>: 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. |
| format | Article |
| id | doaj-art-95f1df662069446ba167273f5f41b56d |
| institution | Kabale University |
| issn | 2076-393X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj-art-95f1df662069446ba167273f5f41b56d2025-01-24T13:51:45ZengMDPI AGVaccines2076-393X2025-01-011314310.3390/vaccines13010043Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical TrialFengcai Zhu0Ting Huang1Pengfei Jin2Linglin Zhang3Zhongqiang Jin4Wenli Zhang5Dongya Yuan6Zhong Wang7Yusong Deng8Jiaxin Li9Xiao Shen10Yongpan Fu11Jian Li12Xinjie Yang13Jing Li14Liangzhi Xie15Jiangsu Provincial Center for Disease Control and Prevention, Jiangsu Provincial Academy of Preventive Medicine, Nanjing 210009, ChinaSichuan Center for Disease Prevention and Control, Chengdu 610041, ChinaJiangsu Provincial Center for Disease Control and Prevention, Jiangsu Provincial Academy of Preventive Medicine, Nanjing 210009, ChinaSichuan Center for Disease Prevention and Control, Chengdu 610041, ChinaSichuan Center for Disease Prevention and Control, Chengdu 610041, ChinaSichuan Center for Disease Prevention and Control, Chengdu 610041, ChinaDazhu County Disease Prevention Control Center, Dazhu 635199, ChinaDazhu County Disease Prevention Control Center, Dazhu 635199, ChinaDazhu County Disease Prevention Control Center, Dazhu 635199, ChinaDazhu County Disease Prevention Control Center, Dazhu 635199, ChinaDazhu County Disease Prevention Control Center, Dazhu 635199, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China<b>Background</b>: 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. <b>Objective</b>: 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). <b>Methods</b>: 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. <b>Results</b>: 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, <i>p</i> < 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%) (<i>p</i> = 0.029), and the lower bound of the 95%CI was >−5%, indicating superiority. <b>Conclusions</b>: 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.https://www.mdpi.com/2076-393X/13/1/43children and adolescentsimmunogenicitysafetymultivalent vaccineSARS-CoV-2 |
| spellingShingle | Fengcai Zhu Ting Huang Pengfei Jin Linglin Zhang Zhongqiang Jin Wenli Zhang Dongya Yuan Zhong Wang Yusong Deng Jiaxin Li Xiao Shen Yongpan Fu Jian Li Xinjie Yang Jing Li Liangzhi Xie Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Vaccines children and adolescents immunogenicity safety multivalent vaccine SARS-CoV-2 |
| title | Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial |
| title_full | Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial |
| title_fullStr | Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial |
| title_full_unstemmed | Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial |
| title_short | Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial |
| title_sort | safety and immunogenicity of the tetravalent recombinant covid 19 protein vaccine sctv01e in children and adolescents aged 3 to 17 years a randomized double blind placebo controlled phase 2 clinical trial |
| topic | children and adolescents immunogenicity safety multivalent vaccine SARS-CoV-2 |
| url | https://www.mdpi.com/2076-393X/13/1/43 |
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