Batch-to-batch consistency trial of an adenovirus type-5 vector-based COVID-19 vaccine in adults aged 18 years and above

Zhuo-Pei Li, Yun-Feng Shi, Li-Hua Hou, Peng-Fei Jin, Shi-Hua Ma, Hong-Xing Pan, Jin-Long Zhang, Yong-Mei Shan, Hai-Tao Huang, Shi-Po Wu, Pan Du, Xue Wang, Li-Li Wang, Rui-Jie Wang, Ying Wang, Xue-Wen Wang, Feng-Cai Zhu & Jing-Xin Li
The demonstration of batch-to-batch consistency is indispensable for quality control of vaccines. We conducted a randomized, double-blind, parallel-controlled trial to evaluate the immunogenicity consistency of a single shot of Ad5-nCoV in healthy adults who had not previously received any COVID-19 vaccine. All eligible participants were randomly assigned equally to receive one of the three consecutive batches of Ad5-nCoV (5 × 1010 viral particles/vial, 0.5 mL). The primary endpoint was geometric mean titers (GMTs) of serum...
1 citation reported since publication in 2022.
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