Efficacy and Safety of the RBD-Dimer–Based Covid-19 Vaccine ZF2001 in Adults

ZF2001 contains a tandem-repeat dimeric receptor-binding domain of the SARS-CoV-2 spike protein with aluminum hydroxide adjuvant. In a phase 3 trial, 28,904 participants in five countries were randomly assigned to receive three doses of ZF2001 or placebo. After 6 months of follow-up, efficacy was 76...

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Published inThe New England journal of medicine Vol. 386; no. 22; pp. 2097 - 2111
Main Authors Dai, Lianpan, Gao, Lidong, Tao, Lifeng, Hadinegoro, Sri R., Erkin, Musabaev, Ying, Zhifang, He, Peng, Girsang, Rodman T., Vergara, Hugo, Akram, Javed, Satari, Hindra I., Khaliq, Tanwir, Sughra, Ume, Celi, Ana P., Li, Fangjun, Li, Yan, Jiang, Zhiwei, Dalimova, Dilbar, Tuychiev, Jaloliddin, Turdikulova, Shahlo, Ikram, Aamer, Flores Lastra, Nancy, Ding, Fan, Suhardono, Mahendra, Fadlyana, Eddy, Yan, Jinghua, Hu, Zhongyu, Li, Changgui, Abdurakhmonov, Ibrokhim Y., Gao, George F.
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 02.06.2022
Subjects
Adult
Adverse events
Aluminum
Aluminum hydroxide
Antigens
Clinical trials
Coronavirus
Coronaviruses
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Double-Blind Method
Humans
Immunogenicity
Infectious Disease
Informed consent
Original
Pandemics
Placebos
Proteins
Safety
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
Vaccination
Vaccine efficacy
Vaccines
Viral Infections
Uzbekistan
China
Indonesia
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Summary:ZF2001 contains a tandem-repeat dimeric receptor-binding domain of the SARS-CoV-2 spike protein with aluminum hydroxide adjuvant. In a phase 3 trial, 28,904 participants in five countries were randomly assigned to receive three doses of ZF2001 or placebo. After 6 months of follow-up, efficacy was 76% against infection, 87% against critical or severe disease, and 86% against death. Most side effects were local, low-grade, and transient.
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A complete list of the members of the ZF2001 Global Trial Group is provided in the Supplementary Appendix, available at NEJM.org.
Dr. Dai, Mr. L. Gao, Drs. Hadinegoro and Erkin, Ms. Ying, Ms. Hu, and Drs. C. Li and Abdurakhmonov contributed equally to this article.
ISSN:0028-4793
1533-4406
1533-4406
DOI:10.1056/NEJMoa2202261