Safety, efficacy and immunogenicity of aerosolized Ad5-nCoV COVID-19 vaccine in a non-inferiority randomized controlled trial
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.
Authors
- Min Hui Tan (ORCID: https://orcid.org/0000-0003-2807-6421)
- Lihua Hou (ORCID: https://orcid.org/0000-0003-3644-2612)
- Mohamad R. Mohd Din
- W.H. Wan Mohamad
- Sharon Shi Min Ng (ORCID: https://orcid.org/0000-0001-6873-9483)
- Gary Chun (ORCID: https://orcid.org/0000-0002-9733-1126)
- Shipo Wu (ORCID: https://orcid.org/0000-0001-8083-247X)
- Yusi Liu
- Sunita Bavanandan (ORCID: https://orcid.org/0000-0001-5521-6480)
- Reena Rajasuriar (ORCID: https://orcid.org/0000-0003-3756-0629)
- Xiaoyuan Zhao (ORCID: https://orcid.org/0000-0002-8628-2023)
- Kit Yee Cheah (ORCID: https://orcid.org/0000-0001-6397-5735)
- Yi L. Lee
- Jin-Bo Gou
- Baoying Huang (ORCID: https://orcid.org/0000-0001-9516-1146)
- Chun Keat Chew (ORCID: https://orcid.org/0000-0002-7674-5143)
- Tao Zhu (ORCID: https://orcid.org/0000-0003-4197-0065)
- Wan Mohd Rasis Wan Ahmad Kamil (ORCID: https://orcid.org/0000-0002-3419-5649)
- Voon Kin Chin (ORCID: https://orcid.org/0000-0003-4031-5851)
- Rosnawati Yahya (ORCID: https://orcid.org/0000-0002-1347-5318)
- Jasmine S.M. Teo (ORCID: https://orcid.org/0000-0002-5413-0324)
- Lina Wang (ORCID: https://orcid.org/0000-0002-1474-9173)
- Zhe Zhang (ORCID: https://orcid.org/0000-0002-9303-8221)
- Mengning Yan (ORCID: https://orcid.org/0000-0002-4495-3351)
- Xiaoyu Xu (ORCID: https://orcid.org/0000-0001-6958-6597)
- Xuewen Wang (ORCID: https://orcid.org/0000-0001-8995-4799)
- Ruijie Wang (ORCID: https://orcid.org/0000-0001-9611-4974)
- Damenthi Nair
- Teck Onn Lim
- Azrini Abdul Aziz
- Norliza Zainudin
- Lai Hui Pang
- S. S. Ch’ng
- Sumeyya Ahmed
- Aisyah Mohd Norzi
Institutions
- Ministry of Health (MY)
- Hospital Kuala Lumpur (MY)
- University of Malaya (MY)
- Cancer Research Malaysia (MY)
- CanSino (China) (CN)
- Hospital Selayang (MY)
- KPJ Ampang Puteri Specialist Hospital (MY)
Publication Details
- Journal
- npj Vaccines
- Published
- 2024-10-31
- DOI
- https://doi.org/10.1038/s41541-024-01003-x
- Citations
- 7
- Primary Topic
- SARS-CoV-2 and COVID-19 Research
- Type
- article
- Field-Weighted Citation Impact
- 2.72