Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants
Background The development of bivalent or multivalent vaccines offers a promising strategy for combating SARS-CoV-2 mutations.Research design and methods In this phase 2 trial, conducted from 1 December 2021, to 25 July 2023, 392 unvaccinated adults aged ≥18 years were randomized to receive a primar...
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Taylor & Francis Group
2025-12-01
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| Series: | Expert Review of Vaccines |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/14760584.2025.2456231 |
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| author | Guiqiang Wang Kexin Zhao Xiuli Zhao Yimin Cui Peng He Tianzuo Zhang Yanchao Wang Rui Shi Yanhua Li Qian Wang Yanping Ren Zhisong Chen Xuedan Zhao Zekang Xie Yufei Liang Qingyun Tian Jing Pan Chao Zhang Ying Han Yuyang Dai Siyang Ni Yun Zhang Xinjie Yang Yongpan Fu Dongfang Liu Jing Li Miaomiao Zhang Zhongyu Hu Liangzhi Xie |
| author_facet | Guiqiang Wang Kexin Zhao Xiuli Zhao Yimin Cui Peng He Tianzuo Zhang Yanchao Wang Rui Shi Yanhua Li Qian Wang Yanping Ren Zhisong Chen Xuedan Zhao Zekang Xie Yufei Liang Qingyun Tian Jing Pan Chao Zhang Ying Han Yuyang Dai Siyang Ni Yun Zhang Xinjie Yang Yongpan Fu Dongfang Liu Jing Li Miaomiao Zhang Zhongyu Hu Liangzhi Xie |
| author_sort | Guiqiang Wang |
| collection | DOAJ |
| description | Background The development of bivalent or multivalent vaccines offers a promising strategy for combating SARS-CoV-2 mutations.Research design and methods In this phase 2 trial, conducted from 1 December 2021, to 25 July 2023, 392 unvaccinated adults aged ≥18 years were randomized to receive a primary series of two doses and a booster dose of SCTV01C, a bivalent protein SARS-CoV-2 vaccine.Results Geometric mean titers (GMTs) of neutralizing antibodies (nAb) against live Alpha, Beta, Delta, and Omicron showed 85.4-, 100.0-, 32.1-, and 9.8-fold increase from baseline on 28 days, and 49.4-, 55.3-, 5.7-fold increase against live Alpha, Beta, and Omicron on 90 days after primary series. At Day 28 and Day 90 following the booster dose, GMTs of nAb against Beta, BA.2 and BA.5 variants showed 12.1- and 8.8-, 13.8- and 7.1-, 18.7-, and 11.9-fold of increase from baseline, respectively. Reactogenicity was generally mild, with one adverse event of special interest (AESI) and 9 ≥Grade 3 treatment-related adverse events (TRAEs); all recovered within 3 days.Conclusions SCTV01C, when administered as both a primary series and a booster vaccination, exhibited encouraging sustained immunogenicity against both antigen-matched and antigen-mismatched variants, with no significant safety concerns.Clinical trial registration www.clinicaltrials.gov identifier is NCT05148091. |
| format | Article |
| id | doaj-art-f613b5f17b774955a1f8a718660a3fd0 |
| institution | Kabale University |
| issn | 1476-0584 1744-8395 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Expert Review of Vaccines |
| spelling | doaj-art-f613b5f17b774955a1f8a718660a3fd02025-01-28T05:53:53ZengTaylor & Francis GroupExpert Review of Vaccines1476-05841744-83952025-12-0124112813710.1080/14760584.2025.2456231Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variantsGuiqiang Wang0Kexin Zhao1Xiuli Zhao2Yimin Cui3Peng He4Tianzuo Zhang5Yanchao Wang6Rui Shi7Yanhua Li8Qian Wang9Yanping Ren10Zhisong Chen11Xuedan Zhao12Zekang Xie13Yufei Liang14Qingyun Tian15Jing Pan16Chao Zhang17Ying Han18Yuyang Dai19Siyang Ni20Yun Zhang21Xinjie Yang22Yongpan Fu23Dongfang Liu24Jing Li25Miaomiao Zhang26Zhongyu Hu27Liangzhi Xie28Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, Beijing, ChinaHebei Petro China Central Hospital, Langfang, ChinaBeijing Tong Reng Hospital, Capital Medical University, Beijing, ChinaDepartment of Pharmacy, Peking University First Hospital, Beijing, ChinaNational Institutes for Food and Drug Control, Beijing, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaHebei Petro China Central Hospital, Langfang, ChinaBeijing Tong Reng Hospital, Capital Medical University, Beijing, ChinaBeijing Tong Reng Hospital, Capital Medical University, Beijing, ChinaBeijing Tong Reng Hospital, Capital Medical University, Beijing, ChinaBeijing Tong Reng Hospital, Capital Medical University, Beijing, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd, Beijing, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd, Beijing, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd, Beijing, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd, Beijing, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd, Beijing, ChinaNational Institutes for Food and Drug Control, Beijing, ChinaBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd, Beijing, ChinaBackground The development of bivalent or multivalent vaccines offers a promising strategy for combating SARS-CoV-2 mutations.Research design and methods In this phase 2 trial, conducted from 1 December 2021, to 25 July 2023, 392 unvaccinated adults aged ≥18 years were randomized to receive a primary series of two doses and a booster dose of SCTV01C, a bivalent protein SARS-CoV-2 vaccine.Results Geometric mean titers (GMTs) of neutralizing antibodies (nAb) against live Alpha, Beta, Delta, and Omicron showed 85.4-, 100.0-, 32.1-, and 9.8-fold increase from baseline on 28 days, and 49.4-, 55.3-, 5.7-fold increase against live Alpha, Beta, and Omicron on 90 days after primary series. At Day 28 and Day 90 following the booster dose, GMTs of nAb against Beta, BA.2 and BA.5 variants showed 12.1- and 8.8-, 13.8- and 7.1-, 18.7-, and 11.9-fold of increase from baseline, respectively. Reactogenicity was generally mild, with one adverse event of special interest (AESI) and 9 ≥Grade 3 treatment-related adverse events (TRAEs); all recovered within 3 days.Conclusions SCTV01C, when administered as both a primary series and a booster vaccination, exhibited encouraging sustained immunogenicity against both antigen-matched and antigen-mismatched variants, with no significant safety concerns.Clinical trial registration www.clinicaltrials.gov identifier is NCT05148091.https://www.tandfonline.com/doi/10.1080/14760584.2025.2456231SafetyimmunogenicitySARS-CoV-2multivalent vaccinebooster |
| spellingShingle | Guiqiang Wang Kexin Zhao Xiuli Zhao Yimin Cui Peng He Tianzuo Zhang Yanchao Wang Rui Shi Yanhua Li Qian Wang Yanping Ren Zhisong Chen Xuedan Zhao Zekang Xie Yufei Liang Qingyun Tian Jing Pan Chao Zhang Ying Han Yuyang Dai Siyang Ni Yun Zhang Xinjie Yang Yongpan Fu Dongfang Liu Jing Li Miaomiao Zhang Zhongyu Hu Liangzhi Xie Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants Expert Review of Vaccines Safety immunogenicity SARS-CoV-2 multivalent vaccine booster |
| title | Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants |
| title_full | Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants |
| title_fullStr | Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants |
| title_full_unstemmed | Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants |
| title_short | Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants |
| title_sort | sustained immunogenicity of bivalent protein covid 19 vaccine sctv01c against antigen matched and mismatched variants |
| topic | Safety immunogenicity SARS-CoV-2 multivalent vaccine booster |
| url | https://www.tandfonline.com/doi/10.1080/14760584.2025.2456231 |
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