tetano
Editor, Senior Moderator
Nat Commun
. 2024 Jul 24;15(1):6255.
doi: 10.1038/s41467-024-49832-7. Efficacy of the tetravalent protein COVID-19 vaccine, SCTV01E: a phase 3 double-blind, randomized, placebo-controlled trial
Ruizhi Zhang[SUP] #[/SUP][SUP] 1 [/SUP], Junshi Zhao[SUP] #[/SUP][SUP] 2 [/SUP], Xiaoping Zhu[SUP] #[/SUP][SUP] 3 [/SUP], Qinghu Guan[SUP] 1 [/SUP], Shujun Liu[SUP] 2 [/SUP], Meihong Li[SUP] 3 [/SUP], Jianghua Gao[SUP] 4 [/SUP], Jie Tan[SUP] 4 [/SUP], Feng Cao[SUP] 5 [/SUP], Beifang Gan[SUP] 6 [/SUP], Bo Wu[SUP] 7 [/SUP], Jin Bai[SUP] 8 [/SUP], Youquan Liu[SUP] 9 [/SUP], Gang Xie[SUP] 10 [/SUP], Chi Liu[SUP] 11 [/SUP], Wei Zhao[SUP] 12 [/SUP], Lixin Yan[SUP] 13 [/SUP], Shuping Xu[SUP] 13 [/SUP], Gui Qian[SUP] 13 [/SUP], Dongfang Liu[SUP] 13 [/SUP], Jian Li[SUP] 13 [/SUP], Wei Li[SUP] 13 [/SUP], Xuxin Tian[SUP] 13 [/SUP], Jinling Wang[SUP] 13 [/SUP], Shanshan Wang[SUP] 13 [/SUP], Dongyang Li[SUP] 13 [/SUP], Jing Li[SUP] 13 [/SUP], Yuhuan Jiao[SUP] 13 [/SUP], Xuefeng Li[SUP] 13 [/SUP], Yuanxin Chen[SUP] 13 [/SUP], Yang Wang[SUP] 13 [/SUP], Wenlin Gai[SUP] 13 [/SUP], Qiang Zhou[SUP] 13 [/SUP], Liangzhi Xie[SUP] 14 15 [/SUP]
Affiliations
Evolution of SARS-CoV-2 variants emphasizes the need for multivalent vaccines capable of simultaneously targeting multiple strains. SCTV01E is a tetravalent COVID-19 vaccine derived from the spike protein of SARS-CoV-2 variants Alpha, Beta, Delta, and Omicron BA.1. In this double-blinded placebo-controlled pivotal efficacy trial (NCT05308576), the primary endpoint was vaccine efficacy (VE) against COVID-19 seven days post-vaccination in individuals without recent infection. Other endpoints included evaluating safety, immunogenicity, and the VE against all SARS-CoV-2 infections in individuals meeting the study criteria. Between December 26, 2022, and January 15, 2023, 9,223 individuals were randomized at a 1:1 ratio to receive SCTV01E or a placebo. SCTV01E showed a VE of 69.4% (95% CI: 50.6, 81.0) 7 days post-vaccination, with 75 cases in the placebo group and 23 in the SCTV01E group for the primary endpoint. VEs were 79.7% (95% CI: 51.0, 91.6) and 82.4% (95% CI: 57.9, 92.6), respectively, for preventing symptomatic infection and all SARS-CoV-2 infections 14 days post-vaccination. SCTV01E elicited a 25.0-fold higher neutralizing antibody response against Omicron BA.5 28 days post-vaccination compared to placebo. Reactogenicity was generally mild and transient, with no reported vaccine-related SAE, adverse events of special interest (AESI), or deaths. The trial aligned with the shift from dominant variants BA.5 and BF.7 to XBB, suggesting SCTV01E as a potential vaccine alternative effective against present and future variants.
. 2024 Jul 24;15(1):6255.
doi: 10.1038/s41467-024-49832-7. Efficacy of the tetravalent protein COVID-19 vaccine, SCTV01E: a phase 3 double-blind, randomized, placebo-controlled trial
Ruizhi Zhang[SUP] #[/SUP][SUP] 1 [/SUP], Junshi Zhao[SUP] #[/SUP][SUP] 2 [/SUP], Xiaoping Zhu[SUP] #[/SUP][SUP] 3 [/SUP], Qinghu Guan[SUP] 1 [/SUP], Shujun Liu[SUP] 2 [/SUP], Meihong Li[SUP] 3 [/SUP], Jianghua Gao[SUP] 4 [/SUP], Jie Tan[SUP] 4 [/SUP], Feng Cao[SUP] 5 [/SUP], Beifang Gan[SUP] 6 [/SUP], Bo Wu[SUP] 7 [/SUP], Jin Bai[SUP] 8 [/SUP], Youquan Liu[SUP] 9 [/SUP], Gang Xie[SUP] 10 [/SUP], Chi Liu[SUP] 11 [/SUP], Wei Zhao[SUP] 12 [/SUP], Lixin Yan[SUP] 13 [/SUP], Shuping Xu[SUP] 13 [/SUP], Gui Qian[SUP] 13 [/SUP], Dongfang Liu[SUP] 13 [/SUP], Jian Li[SUP] 13 [/SUP], Wei Li[SUP] 13 [/SUP], Xuxin Tian[SUP] 13 [/SUP], Jinling Wang[SUP] 13 [/SUP], Shanshan Wang[SUP] 13 [/SUP], Dongyang Li[SUP] 13 [/SUP], Jing Li[SUP] 13 [/SUP], Yuhuan Jiao[SUP] 13 [/SUP], Xuefeng Li[SUP] 13 [/SUP], Yuanxin Chen[SUP] 13 [/SUP], Yang Wang[SUP] 13 [/SUP], Wenlin Gai[SUP] 13 [/SUP], Qiang Zhou[SUP] 13 [/SUP], Liangzhi Xie[SUP] 14 15 [/SUP]
Affiliations
- PMID: 39048547
- PMCID: PMC11269576
- DOI: 10.1038/s41467-024-49832-7
Evolution of SARS-CoV-2 variants emphasizes the need for multivalent vaccines capable of simultaneously targeting multiple strains. SCTV01E is a tetravalent COVID-19 vaccine derived from the spike protein of SARS-CoV-2 variants Alpha, Beta, Delta, and Omicron BA.1. In this double-blinded placebo-controlled pivotal efficacy trial (NCT05308576), the primary endpoint was vaccine efficacy (VE) against COVID-19 seven days post-vaccination in individuals without recent infection. Other endpoints included evaluating safety, immunogenicity, and the VE against all SARS-CoV-2 infections in individuals meeting the study criteria. Between December 26, 2022, and January 15, 2023, 9,223 individuals were randomized at a 1:1 ratio to receive SCTV01E or a placebo. SCTV01E showed a VE of 69.4% (95% CI: 50.6, 81.0) 7 days post-vaccination, with 75 cases in the placebo group and 23 in the SCTV01E group for the primary endpoint. VEs were 79.7% (95% CI: 51.0, 91.6) and 82.4% (95% CI: 57.9, 92.6), respectively, for preventing symptomatic infection and all SARS-CoV-2 infections 14 days post-vaccination. SCTV01E elicited a 25.0-fold higher neutralizing antibody response against Omicron BA.5 28 days post-vaccination compared to placebo. Reactogenicity was generally mild and transient, with no reported vaccine-related SAE, adverse events of special interest (AESI), or deaths. The trial aligned with the shift from dominant variants BA.5 and BF.7 to XBB, suggesting SCTV01E as a potential vaccine alternative effective against present and future variants.