Safety, efficacy and immunogenicity of aerosolized Ad5-nCoV COVID-19 vaccine in a non-inferiority randomized controlled trial

Authors

• 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 RajasuriarFollow
• 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

Document Type

Article

Publication Date

10-1-2024

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.

Publication Title

npj Vaccines

Recommended Citation

Chew, Chun K.; Wang, Ruijie; Bavanandan, Sunita; Zainudin, Norliza; Zhao, Xiaoyuan; Ahmed, Sumeyya; Nair, Damenthi; Hou, Lihua; Yahya, Rosnawati; Ch'ng, Shereen S.; Pang, Lai H.; Abdul Aziz, Azrini; Huang, Haitao; Rajasuriar, Reena; Wu, Shipo; Zhang, Zhe; Wang, Xuewen; Chun, Geok Y.; Mohd Norzi, Aisyah; Cheah, Kit Y.; Lee, Yi L.; Wan Mohamad, Wan H.; Mohd Din, Mohamad R.; Wan Ahmad Kamil, Wan M. R.; Tan, Min H.; Xu, Xiaoyu; Wang, Lina; Yan, Meixu; Liu, Yusi; and Chin, Voon K., "Safety, efficacy and immunogenicity of aerosolized Ad5-nCoV COVID-19 vaccine in a non-inferiority randomized controlled trial" (2024). Research Publications (2021 to 2025). 5902.
https://knova.um.edu.my/research_publications_2021_2025/5902

Divisions

medicinedept

Funders

Cansino Biologics Inc.,Tianjin Biomedical Science and Technology Major Project (21ZXSYSY00040),BNT-IM of control arm,Ministry of Health, Malaysia

Volume

9

Issue

1

Publisher

Nature Portfolio

Publisher Location

HEIDELBERGER PLATZ 3, BERLIN, 14197, GERMANY