1. Efficacy of the tetravalent protein COVID-19 vaccine, SCTV01E: a phase 3 double-blind, randomized, placebo-controlled trial
- Author
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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
- Subjects
Science - 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.
- Published
- 2024
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