Chew, Chun K. and Wang, Ruijie and Bavanandan, Sunita and Zainudin, Norliza and Zhao, Xiaoyuan and Ahmed, Sumeyya and Nair, Damenthi and Hou, Lihua and Yahya, Rosnawati and Ch'ng, Shereen S. and Pang, Lai H. and Abdul Aziz, Azrini and Huang, Haitao and Rajasuriar, Reena and Wu, Shipo and Zhang, Zhe and Wang, Xuewen and Chun, Geok Y. and Mohd Norzi, Aisyah and Cheah, Kit Y. and Lee, Yi L. and Wan Mohamad, Wan H. and Mohd Din, Mohamad R. and Wan Ahmad Kamil, Wan M. R. and Tan, Min H. and Xu, Xiaoyu and Wang, Lina and Yan, Meixu and Liu, Yusi and Chin, Voon K. and Teo, Jau S. and Lim, Teck O. and Zhu, Tao and Gou, Jinbo and Ng, Sharon S. M. (2024) Safety, efficacy and immunogenicity of aerosolized Ad5-nCoV COVID-19 vaccine in a non-inferiority randomized controlled trial. npj Vaccines, 9 (1). p. 209. ISSN 2059-0105, DOI https://doi.org/10.1038/s41541-024-01003-x.
Full text not available from this repository.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.
| Item Type: | Article |
|---|---|
| Funders: | Cansino Biologics Inc., Tianjin Biomedical Science and Technology Major Project (21ZXSYSY00040), BNT-IM of control arm, Ministry of Health, Malaysia |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Faculty of Medicine > Medicine Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 18 Feb 2025 01:51 |
| Last Modified: | 18 Feb 2025 01:51 |
| URI: | http://eprints.um.edu.my/id/eprint/47385 |
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