{"title":"二价蛋白COVID-19疫苗SCTV01C对抗原匹配和不匹配变体的持续免疫原性","authors":"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","doi":"10.1080/14760584.2025.2456231","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The development of bivalent or multivalent vaccines offers a promising strategy for combating SARS-CoV-2 mutations.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trial registration: </strong>www.clinicaltrials.gov identifier is NCT05148091.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"128-137"},"PeriodicalIF":5.5000,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants.\",\"authors\":\"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\",\"doi\":\"10.1080/14760584.2025.2456231\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The development of bivalent or multivalent vaccines offers a promising strategy for combating SARS-CoV-2 mutations.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trial registration: </strong>www.clinicaltrials.gov identifier is NCT05148091.</p>\",\"PeriodicalId\":12326,\"journal\":{\"name\":\"Expert Review of Vaccines\",\"volume\":\" \",\"pages\":\"128-137\"},\"PeriodicalIF\":5.5000,\"publicationDate\":\"2025-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Review of Vaccines\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14760584.2025.2456231\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/27 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Vaccines","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14760584.2025.2456231","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/27 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
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 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.
期刊介绍：
Expert Review of Vaccines (ISSN 1476-0584) provides expert commentary on the development, application, and clinical effectiveness of new vaccines. Coverage includes vaccine technology, vaccine adjuvants, prophylactic vaccines, therapeutic vaccines, AIDS vaccines and vaccines for defence against bioterrorism. All articles are subject to rigorous peer-review.
The vaccine field has been transformed by recent technological advances, but there remain many challenges in the delivery of cost-effective, safe vaccines. Expert Review of Vaccines facilitates decision making to drive forward this exciting field.
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