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ABSTRACT
Background
The certification of immunogenicity consistency at different production scales is indispensable for the quality control of vaccines.
Research design and methods
A randomized, double-blind immunobridging trial in healthy adults aged 18–59 was divided into Scale A (50 L and 800 L) and Scale B (50 L and 500 L) based on vaccine manufacturing scales. Eligible participants in Scale A were randomly assigned to receive the single-dose recombinant adenovirus type-5 vectored COVID-19 vaccine (Ad5-nCoV) of different scales at a 1:1 ratio, as was Scale B. The primary endpoint was the geometric mean titer (GMT) of anti-live SARS-CoV-2-specific neutralizing antibodies (NAb) 28 days post-vaccination.
Results
1,012 participants were enrolled, with 253 (25%) per group. The post-vaccination GMTs of NAb were 10.72 (95% CI: 9.43, 12.19) and 13.23 (11.64, 15.03) in Scale A 50 L and 800 L, respectively; 11.64 (10.12, 13.39) and 12.09 (10.48, 13.95) in Scale B 50 L and 500 L, respectively. GMT ratios in Scale A and B have a 95% CI of 0.67–1.5. Most adverse reactions were mild or moderate. 17 of 18 participants reported non-vaccination-related serious adverse reactions.
Conclusions
The Ad5-nCoV in the scale-up production of 500 L and 800 L showed consistent immunogenicity with the original 50 L production scale, respectively.
GRAPHICAL ABSTRACT
Author contributions
Feng-cai Zhu was the principal investigator of this trial. Feng-cai Zhu and Jing-xin Li designed the trials and the study protocol. Jing-xin Li and Feng-cai Zhu contributed to critical review and revising of the report. Yan-fei Wu, Ming-wei Wei contributed to the data interpretation, drafting, and revising of this manuscript. Rui-jie Wang provided the vaccines of trial and led the trial supervision. Xi-ling Guo led the laboratory tests. Hong-xing Pan contributed to tiral supervision. Ming-wei Wei and Ya-chun Gao led and participated in the site work, including the recruitment, follow-up, and data collection. Xiao-long Li, Xue Wang, Xiao-min Ma, Peng Wan monitored the trial. Li Zhou and Ya-wen Zhu contributed to statistical analysis.
Declaration of interest
RJ Wang, XL Li, X Wang, XM Ma and P Wan are the employees of CanSino Biologics Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14760584.2023.2234997.
Clinical trial registration
www.clinicaltrials.gov identifier is NCT04916886.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Ethical approval
The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. The trial protocol was reviewed and approved by the Chinese National Medical Products Administration (NMPA) and the institutional review board of the Jiangsu Provincial Center of Disease Control and Prevention (JSJK2021-A010-01).