Batch-to-batch consistency trial of an adenovirus type-5 vector-based COVID-19 vaccine in adults aged 18 years and above. (2nd December 2022)

• Record Type: Journal Article
• Authors: Li, Zhuo-Pei; Shi, Yun-Feng; Hou, Li-Hua; Jin, Peng-Fei; Ma, Shi-Hua; Pan, Hong-Xing; Zhang, Jin-Long; Shan, Yong-Mei; Huang, Hai-Tao; Wu, Shi-Po; Du, Pan; Wang, Xue; Wang, Li-Li; Wang, Rui-Jie; Wang, Ying; Wang, Xue-Wen; Zhu, Feng-Cai; Li, Jing-Xin
• Is Part Of: Expert review of vaccines. Volume 21:Number 12(2022)
• Page Start: 1843
• Page End: 1849
• Publication Date: 2022-12-02
• Subjects: Batch consistency -- Ad5-nCoV -- clinical trial -- COVID-19 vaccine -- RBD-specific IgG; Vaccines -- Periodicals; Vaccination -- Periodicals; 615.37205
• DOI: 10.1080/14760584.2022.2119133
• Languages: English
• ISSNs: 1476-0584

Abstract

ABSTRACT: Background: The demonstration of batch-to-batch consistency is indispensable for quality control of vaccines. Methods: 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 × 10 10 viral particles/vial, 0.5 mL). The primary endpoint was geometric mean titers (GMTs) of serum SARS-CoV-2 receptor-binding domain (RBD)-specific IgG on day 28 post-vaccination. Results: One thousand fifty participants were enrolled, with 350 (33%) participants per group. On day 28 post-vaccination, GMTs in three groups were 78.3 binding antibody units (BAU)/mL (95% CI 70.3–87.3), 82.9 BAU/mL (73.9–92.9), and 78.8 BAU/mL (70.2–88.4), respectively. The two-sided 95% CIs for the GMT ratios between each pair of batches were all between 0.67 and 1.5. The highest incidence of solicited adverse reactions within 7 days post-vaccination was reported by batch 3 recipients (23.1% versus 15.1% in batch 1 recipients and 14.6% in bath 2 recipients; p = 0.0039). None of the serious adverse events were related to vaccination. Conclusions: Immunogenicity consistency between consecutive batches of Ad5-nCoV was well established in adults. Clinical trial registration: This trial was registered with ClinicalTrials.gov (NCT05313646).