npj Vaccines (Oct 2024)
Safety, efficacy and immunogenicity of aerosolized Ad5-nCoV COVID-19 vaccine in a non-inferiority randomized controlled trial
- 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,
- Sharon S. M. Ng
Affiliations
- Chun K. Chew
- Centre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia
- Ruijie Wang
- Clinical Operations Center, CanSino Biologics Inc.
- Sunita Bavanandan
- Department of Nephrology, Hospital Kuala Lumpur
- Norliza Zainudin
- Rheumatology Unit, Hospital Selayang
- Xiaoyuan Zhao
- Clinical Operations Center, CanSino Biologics Inc.
- Sumeyya Ahmed
- Clinical Operations Center, CanSino Biologics Inc.
- Damenthi Nair
- Clinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang
- Lihua Hou
- Beijing Institute of Biotechnology
- Rosnawati Yahya
- Department of Nephrology, Hospital Kuala Lumpur
- Shereen S. Ch’ng
- Rheumatology Unit, Hospital Selayang
- Lai H. Pang
- Clinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang
- Azrini Abdul Aziz
- Department of Nephrology, Hospital Kuala Lumpur
- Haitao Huang
- Clinical Operations Center, CanSino Biologics Inc.
- Reena Rajasuriar
- Immunotherapeutcis Laboratory and Department of Medicine, Faculty of Medicine, University Malaya
- Shipo Wu
- Beijing Institute of Biotechnology
- Zhe Zhang
- Beijing Institute of Biotechnology
- Xuewen Wang
- Shanghai ImStat Medical Technology Co., Ltd.
- Geok Y. Chun
- Centre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia
- Aisyah Mohd Norzi
- Clinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang
- Kit Y. Cheah
- Clinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang
- Yi L. Lee
- Clinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang
- Wan H. Wan Mohamad
- Department of Nephrology, Hospital Kuala Lumpur
- Mohamad R. Mohd Din
- Department of Nephrology, Hospital Kuala Lumpur
- Wan M. R. Wan Ahmad Kamil
- Department of Nephrology, Hospital Kuala Lumpur
- Min H. Tan
- Department of Nephrology, Hospital Kuala Lumpur
- Xiaoyu Xu
- Nanjing Vazyme Biotech Co., Ltd.
- Lina Wang
- Clinical Operations Center, CanSino Biologics Inc.
- Meixu Yan
- Clinical Operations Center, CanSino Biologics Inc.
- Yusi Liu
- Clinical Operations Center, CanSino Biologics Inc.
- Voon K. Chin
- Clinical Operations Center, CanSino Biologics Inc.
- Jau S. Teo
- Clindata Consult Sdn Bhd
- Teck O. Lim
- Clin Research Private Enterprise
- Tao Zhu
- Clinical Operations Center, CanSino Biologics Inc.
- Jinbo Gou
- Clinical Operations Center, CanSino Biologics Inc.
- Sharon S. M. Ng
- Centre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia
- DOI
- https://doi.org/10.1038/s41541-024-01003-x
- Journal volume & issue
-
Vol. 9,
no. 1
pp. 1 – 9
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.
