Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial
The Omicron EG.5 lineage of SARS-CoV-2 is currently on a trajectory to become the dominant strain. This phase 2 study aims to evaluate the immunogenicity of SCTV01E-2, a tetravalent protein vaccine, with a specific emphasis on its immunogenicity against Omicron EG.5, comparing it with its progenitor...
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| Language: | English |
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MDPI AG
2024-02-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/12/2/175 |
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| author | Jihai Tang Qinghua Xu Chaoyin Zhu Kun Xuan Tao Li Qingru Li Xingya Pang Zhenqiu Zha Jinwei Li Liyang Qiao Haiyang Xu Gang Wu Yan Tian Jun Han Cuige Gao Jiang Yi Gui Qian Xuxin Tian Liangzhi Xie |
| author_facet | Jihai Tang Qinghua Xu Chaoyin Zhu Kun Xuan Tao Li Qingru Li Xingya Pang Zhenqiu Zha Jinwei Li Liyang Qiao Haiyang Xu Gang Wu Yan Tian Jun Han Cuige Gao Jiang Yi Gui Qian Xuxin Tian Liangzhi Xie |
| author_sort | Jihai Tang |
| collection | DOAJ |
| description | The Omicron EG.5 lineage of SARS-CoV-2 is currently on a trajectory to become the dominant strain. This phase 2 study aims to evaluate the immunogenicity of SCTV01E-2, a tetravalent protein vaccine, with a specific emphasis on its immunogenicity against Omicron EG.5, comparing it with its progenitor vaccine, SCTV01E (NCT05933512). As of 12 September 2023, 429 participants aged ≥18 years were randomized into the groups SCTV01E (N = 215) and SCTV01E-2 (N = 214). Both vaccines showed increases in neutralizing antibody (nAb) against Omicron EG.5, with a 5.7-fold increase and a 9.0-fold increase in the SCTV01E and SCTV01E-2 groups 14 days post-vaccination, respectively. The predetermined statistical endpoints were achieved, showing that the geometric mean titer (GMT) of nAb and the seroresponse rate (SRR) against Omicron EG.5 were significantly higher in the SCTV01E-2 group than in the SCTV01E group. Additionally, SCTV01E and SCTV01E-2 induced a 5.5-fold and a 5.9-fold increase in nAb against XBB.1, respectively. Reactogenicity was generally mild and transient. No vaccine-related serious adverse events (SAEs), adverse events of special interest (AESIs), or deaths were reported. In summary, SCTV01E-2 elicited robust neutralizing responses against Omicron EG.5 and XBB.1 without raising safety concerns, highlighting its potential as a versatile COVID-19 vaccine against SARS-CoV-2 variants. |
| first_indexed | 2024-03-07T22:11:32Z |
| format | Article |
| id | doaj.art-e7ebdacb175e40009eea37eeaf80f49e |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-07T22:11:32Z |
| publishDate | 2024-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-e7ebdacb175e40009eea37eeaf80f49e2024-02-23T15:37:04ZengMDPI AGVaccines2076-393X2024-02-0112217510.3390/vaccines12020175Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 TrialJihai Tang0Qinghua Xu1Chaoyin Zhu2Kun Xuan3Tao Li4Qingru Li5Xingya Pang6Zhenqiu Zha7Jinwei Li8Liyang Qiao9Haiyang Xu10Gang Wu11Yan Tian12Jun Han13Cuige Gao14Jiang Yi15Gui Qian16Xuxin Tian17Liangzhi Xie18Anhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, ChinaAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, ChinaFunan County Center for Disease Control and Prevention, Fuyang 236399, ChinaAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, ChinaAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, ChinaAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, ChinaAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, ChinaAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, ChinaFuyang Center for Disease Control and Prevention, Fuyang 236030, ChinaFunan County Center for Disease Control and Prevention, Fuyang 236399, ChinaFuyang Center for Disease Control and Prevention, Fuyang 236030, ChinaFunan County Center for Disease Control and Prevention, Fuyang 236399, ChinaFunan County Center for Disease Control and Prevention, Fuyang 236399, ChinaState Key Laboratory of Infectious, Disease Prevention and Control, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, 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, ChinaThe Omicron EG.5 lineage of SARS-CoV-2 is currently on a trajectory to become the dominant strain. This phase 2 study aims to evaluate the immunogenicity of SCTV01E-2, a tetravalent protein vaccine, with a specific emphasis on its immunogenicity against Omicron EG.5, comparing it with its progenitor vaccine, SCTV01E (NCT05933512). As of 12 September 2023, 429 participants aged ≥18 years were randomized into the groups SCTV01E (N = 215) and SCTV01E-2 (N = 214). Both vaccines showed increases in neutralizing antibody (nAb) against Omicron EG.5, with a 5.7-fold increase and a 9.0-fold increase in the SCTV01E and SCTV01E-2 groups 14 days post-vaccination, respectively. The predetermined statistical endpoints were achieved, showing that the geometric mean titer (GMT) of nAb and the seroresponse rate (SRR) against Omicron EG.5 were significantly higher in the SCTV01E-2 group than in the SCTV01E group. Additionally, SCTV01E and SCTV01E-2 induced a 5.5-fold and a 5.9-fold increase in nAb against XBB.1, respectively. Reactogenicity was generally mild and transient. No vaccine-related serious adverse events (SAEs), adverse events of special interest (AESIs), or deaths were reported. In summary, SCTV01E-2 elicited robust neutralizing responses against Omicron EG.5 and XBB.1 without raising safety concerns, highlighting its potential as a versatile COVID-19 vaccine against SARS-CoV-2 variants.https://www.mdpi.com/2076-393X/12/2/175safetyimmunogenicitySARS-CoV-2multivalent vaccinebooster |
| spellingShingle | Jihai Tang Qinghua Xu Chaoyin Zhu Kun Xuan Tao Li Qingru Li Xingya Pang Zhenqiu Zha Jinwei Li Liyang Qiao Haiyang Xu Gang Wu Yan Tian Jun Han Cuige Gao Jiang Yi Gui Qian Xuxin Tian Liangzhi Xie Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial Vaccines safety immunogenicity SARS-CoV-2 multivalent vaccine booster |
| title | Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial |
| title_full | Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial |
| title_fullStr | Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial |
| title_full_unstemmed | Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial |
| title_short | Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial |
| title_sort | immunogenicity of tetravalent protein vaccine sctv01e 2 against sars cov 2 eg 5 subvaraint a phase 2 trial |
| topic | safety immunogenicity SARS-CoV-2 multivalent vaccine booster |
| url | https://www.mdpi.com/2076-393X/12/2/175 |
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