Efficacy of the tetravalent protein COVID-19 vaccine, SCTV01E: a phase 3 double-blind, randomized, placebo-controlled trial

Ruizhi Zhang, Junshi Zhao, Xiaoping Zhu, Qinghu Guan, Shujun Liu, Meihong Li, Jianghua Gao, Jie Tan, Feng Cao, Beifang Gan, Bo Wu, Jin Bai, Youquan Liu, Gang Xie, Chi Liu, Wei Zhao, Lixin Yan, Shuping Xu, Gui Qian, Dongfang Liu, Jian Li, Wei Li, Xuxin Tian, Jinling Wang, Shanshan Wang, Dongyang Li, Jing Li, Yuhuan Jiao, Xuefeng Li, Yuanxin Chen, Yang Wang, Wenlin Gai, Qiang Zhou and Liangzhi Xie ()
Additional contact information
Ruizhi Zhang: Guizhou Center for Disease Control and Prevention
Junshi Zhao: Hunan Provincial Center for Disease Control and Prevention
Xiaoping Zhu: Sichuan Provincial Center for Disease Control and Prevention
Qinghu Guan: Guizhou Center for Disease Control and Prevention
Shujun Liu: Hunan Provincial Center for Disease Control and Prevention
Meihong Li: Sichuan Provincial Center for Disease Control and Prevention
Jianghua Gao: Songtao Miao Autonomous County Center for Disease Control and Prevention
Jie Tan: Songtao Miao Autonomous County Center for Disease Control and Prevention
Feng Cao: Xiangtan City Center for Disease Control and Prevention
Beifang Gan: Shimen County Center for Disease Control and Prevention
Bo Wu: Dejiang County Center for Disease Control and Prevention
Jin Bai: Sinan County Center for Disease Control and Prevention (County CDC)
Youquan Liu: Mianyang City Center for Disease Control and Prevention
Gang Xie: Mianyang Youxian District Center for Disease Control and Prevention
Chi Liu: Yuping Dong Autonomous County
Wei Zhao: Nanbu County disease control and prevention center
Lixin Yan: Sinocelltech Ltd
Shuping Xu: Sinocelltech Ltd
Gui Qian: Sinocelltech Ltd
Dongfang Liu: Sinocelltech Ltd
Jian Li: Sinocelltech Ltd
Wei Li: Sinocelltech Ltd
Xuxin Tian: Sinocelltech Ltd
Jinling Wang: Sinocelltech Ltd
Shanshan Wang: Sinocelltech Ltd
Dongyang Li: Sinocelltech Ltd
Jing Li: Sinocelltech Ltd
Yuhuan Jiao: Sinocelltech Ltd
Xuefeng Li: Sinocelltech Ltd
Yuanxin Chen: Sinocelltech Ltd
Yang Wang: Sinocelltech Ltd
Wenlin Gai: Sinocelltech Ltd
Qiang Zhou: Sinocelltech Ltd
Liangzhi Xie: Sinocelltech Ltd

Nature Communications, 2024, vol. 15, issue 1, 1-11

Abstract: Abstract 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.

Date: 2024
References: View references in EconPapers View complete reference list from CitEc
Citations:

Downloads: (external link)
https://www.nature.com/articles/s41467-024-49832-7 Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-49832-7

Ordering information: This journal article can be ordered from
https://www.nature.com/ncomms/

DOI: 10.1038/s41467-024-49832-7

Access Statistics for this article

Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie

More articles in Nature Communications from Nature
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().