1. Safety, efficacy and immunogenicity of aerosolized Ad5-nCoV COVID-19 vaccine in a non-inferiority randomized controlled trial
- Author
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Chun K. Chew, Ruijie Wang, Sunita Bavanandan, Norliza Zainudin, Xiaoyuan Zhao, Sumeyya Ahmed, Damenthi Nair, Lihua Hou, Rosnawati Yahya, Shereen S. Ch’ng, Lai H. Pang, Azrini Abdul Aziz, Haitao Huang, Reena Rajasuriar, Shipo Wu, Zhe Zhang, Xuewen Wang, Geok Y. Chun, Aisyah Mohd Norzi, Kit Y. Cheah, Yi L. Lee, Wan H. Wan Mohamad, Mohamad R. Mohd Din, Wan M. R. Wan Ahmad Kamil, Min H. Tan, Xiaoyu Xu, Lina Wang, Meixu Yan, Yusi Liu, Voon K. Chin, Jau S. Teo, Teck O. Lim, Tao Zhu, Jinbo Gou, and Sharon S. M. Ng
- Subjects
Immunologic diseases. Allergy ,RC581-607 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract This phase 3, observer-blinded, non-inferiority randomized trial (ClinicalTrials.gov: NCT05517642), conducted from September 2022 to May 2023 at three Malaysian sites, involved 540 adults previously vaccinated with three COVID-19 doses. Participants were randomized 1:1 to receive either one dose of inhaled Recombinant COVID-19 Vaccine (Ad5-nCoV-IH) or intramuscular tozinameran (BNT-IM). The study assessed safety, vaccine efficacy (VE) and immunogenicity against SARS-CoV-2 variants. The primary outcome was the non-inferiority of anti-spike protein receptor-binding domain (S-RBD IgG) antibodies, with a 97.5% confidence interval lower limit for the geometric mean concentration (GMC) ratio >0.67. Ad5-nCoV-IH showed lower immunogenicity than BNT-IM, with a GMC ratio of 0.22 and a seroconversion rate difference of -71.91%. Adverse drug reactions (ADRs) were less frequent with Ad5-nCoV-IH (39.26%) compared to BNT-IM (64.68%). No serious vaccine-related adverse events were reported. Both vaccines had comparable efficacy against COVID-19 variants. This study was funded by Tianjin Biomedical Science and Technology Major Project.
- Published
- 2024
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