Corresponding Authors: Xiaoming Yang, MD, China National Biotec Group Company Limited, 4 Hui-Xin E St, Chaoyang District, Beijing, China (yangxiaoming@sinopharm.com); An Pan, PhD, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, 13 Hangkong Rd, Qiaokou District, Wuhan, China (panan@hust.edu.cn).
Accepted for Publication: August 3, 2020.
Published Online: August 13, 2020. doi:10.1001/jama.2020.15543
Author Contributions: Dr Xiaoming Yang and Mr Xia had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Mr Xia and Drs Duan and Yuntao Zhang contributed equally and are joint first authors. Drs Shen and Yuan and Mr W Guo are joint last authors.
Concept and design: Xia, Shen, W. Guo, Duan, Yuan, Yuntao Zhang, Li, Yunkai Yang, Chen, L. Zhang, Wu, Xiaoming Yang.
Acquisition, analysis, or interpretation of data: Xia, Zhao, H. Zhang, Xie, Peng, Yanbo Zhang, W. Zhang, Gao, You, X. Wang, Z. Wang, Shi, Y. Wang, Xuqin Yang, L. Huang, Q. Wang, Lu, Yongli Yang, J. Guo, Zhou, Wan, W. Wang, S. Huang, Du, Meng, Pan.
Drafting of the manuscript: Xia, S. Huang, Du, Meng, Pan.
Critical revision of the manuscript for important intellectual content: Xia, Shen, W. Guo, Duan, Yuan, Yuntao Zhang, Zhao, H. Zhang, Xie, Li, Peng, Yanbo Zhang, W. Zhang, Yunkai Yang, Chen, Gao, You, X. Wang, Z. Wang, Shi, Y. Wang, Xuqin Yang, L. Zhang, L. Huang, Q. Wang, Lu, Yongli Yang, J. Guo, Zhou, Wan, Wu, W. Wang, Xiaoming Yang.
Statistical analysis: Yanbo Zhang, Z. Wang, Yongli Yang, Pan.
Obtained funding: Xia, Shen, W. Guo, Duan, Yuan, Yuntao Zhang, X. Wang, Z. Wang, Xiaoming Yang.
Administrative, technical, or material support: Xia, H. Zhang, Yunkai Yang, Chen, Z. Wang.
Supervision: Shen, W. Guo, Duan, Yuan, Yuntao Zhang, Xiaoming Yang.
Conflict of Interest Disclosures: Mr Xia, Mr W Gou, and Drs Duan, Yuntao Zhang, X. Wang, Z. Wang, Yuan, Shen, and Xiaoming Yang reported receiving grants from the Ministry of Science and Technology of the People’s Republic of China during the conduct of the study. Drs Yuntao Zhang, Yunkai Yang, X. Wang, Xuqin Yang, Q. Wang, and Xiaoming Yang reported being employees of the China National Biotec Group Co Ltd. Drs Duan, Li, Z. Wang, Lu, J. Guo, Zhou, Wan, Wu, W. Wang, S. Huang, Meng, and Shen; Mr Chen; and Mr L. Zhang reported being employees of the Wuhan Institute of Biological Products Co Ltd. Dr Du reported being a student of the Wuhan Institute of Biological Products Co Ltd. Dr Yongli Yang reported receiving personal fees from Wuhan Institute of Biological Products Co Ltd during the conduct of the study. No other disclosures were reported.
Funding/Support: This study was supported by the National Program on Key Research Project of China (2020YFC0842100) and Major Science and Technology Project of the National New Drug Development of China (2018ZX09734-004). The vaccine was developed and the study was sponsored by the China National Biotec Group Co Ltd and the Wuhan Institute of Biological Products Co Ltd.
Role of the Funder/Sponsor: The China National Biotec Group Co Ltd and the Wuhan Institute of Biological Products Co Ltd were the study sponsors and designed the trial, provided the study product, and oversaw all trial operations. The sponsors used contract clinical research organizations to coordinate interactions with regulatory authorities and oversee clinical site operations. Data were collected by the clinical site research staff, managed by a blinded contract research organization data management team, monitored by a contract research organization, and overseen by the sponsor and an independent data and safety monitoring board. The interim analysis was performed by an independent statistician who was not involved in the trial after the data were collected, checked, and locked for the specific groups before unblinding. Manuscript preparation was performed by the study authors and the decision to submit the manuscript for publication was made by the study authors.
Data Sharing Statement: See Supplement 4.
Additional Contributions: We are grateful for all investigators at the Henan provincial and Wuzhi county Center for Disease Control and Prevention who contributed to the site work of the trials. We appreciate the contributions of the members in the data and safety monitoring board, including Xiaoju Zhang, MD, and Qiuxing Zhang, MD, from the Henan Province People’s Hospital, and Guoli Yan, MD, from the Henan University of Chinese Medicine. They received remuneration for their work. We thank all the participants in the trial for their dedication to the trial.
3.Zhu
FC , Li
YH , Guan
XH ,
et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial.
Lancet. 2020;395(10240):1845-1854. doi:
10.1016/S0140-6736(20)31208-3PubMedGoogle ScholarCrossref 4.Zhu
FC , Guan
XH , Li
YH ,
et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial.
Lancet. Published online July 20, 2020. doi:
10.1016/S0140-6736(20)31605-6PubMedGoogle Scholar 5.Sahin
U , Muik
A , Derhovanessian
E ,
et al. Concurrent human antibody and T
H1 type T-cell responses elicited by a COVID-19 RNA vaccine.
medRxiv. Preprint posted July 20, 2020. doi:
10.1101/2020.07.17.20140533 6.Mulligan
MJ , Lyke
KE , Kitchin
N ,
et al. Phase 1/2 study to describe the safety and immunogenicity of a COVID-19 RNA vaccine candidate (BNT162b1) in adults 18 to 55 years of age: interim report.
medRxiv. Preprint posted July 1, 2020. doi:
10.1101/2020.06.30.20142570 7.Jackson
LA , Anderson
EJ , Rouphael
NG ,
et al; mRNA-1273 Study Group. An mRNA vaccine against SARS-CoV-2 - preliminary report.
N Engl J Med. Published online July 14, 2020. doi:
10.1056/NEJMoa2022483PubMedGoogle Scholar 8.Folegatti
PM , Ewer
KJ , Aley
PK ,
et al; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial.
Lancet. Published online July 20, 2020. doi:
10.1016/S0140-6736(20)31604-4PubMedGoogle Scholar 11.Wang
H , Zhang
Y , Huang
B ,
et al Development of an inactivated vaccine candidate, BBIBP-CorV, with potent protection against SARS-CoV-2.
Cell. Published online June 6, 2020. doi:
10.1016/j.cell.2020.06.008Google Scholar 14.Luchsinger
LL , Ransegnola
B , Jin
D ,
et al. Serological analysis of New York City COVID19 convalescent plasma donors.
medRxiv. Preprint posted June 9, 2020. doi:
10.1101/2020.06.08.20124792 16.Wang
X , Guo
X , Xin
Q ,
et al. Neutralizing antibodies responses to SARS-CoV-2 in COVID-19 inpatients and convalescent patients.
Clin Infect Dis. Published online June 4, 2020. doi:
10.1093/cid/ciaa721PubMedGoogle Scholar 17.Wu
F , Wang
A , Liu
M ,
et al. Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications.
medRxiv. Preprint posted April 20, 2020. doi:
10.1101/2020.03.30.20047365 18.Zhao
J , Yuan
Q , Wang
H ,
et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019.
Clin Infect Dis. Published online March 28, 2020. doi:
10.1093/cid/ciaa344PubMedGoogle Scholar 19.Liu
T , Wu
S , Tao
H ,
et al. Prevalence of IgG antibodies to SARS-CoV-2 in Wuhan: implications for the ability to produce long-lasting protective antibodies against SARS-CoV-2.
medRxiv. Preprint posted June 16, 2020. doi:
10.1101/2020.06.13.20130252 21.Ibarrondo
FJ , Fulcher
JA , Goodman-Meza
D ,
et al. Rapid decay of anti–SARS-CoV-2 antibodies in persons with mild Covid-19.
N Engl J Med. Published online July 21, 2020. doi:
10.1056/NEJMc2025179PubMedGoogle Scholar 23.Lin
JT , Zhang
JS , Su
N ,
et al. Safety and immunogenicity from a phase I trial of inactivated severe acute respiratory syndrome coronavirus vaccine.
Antivir Ther. 2007;12(7):1107-1113.
PubMedGoogle Scholar