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
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引用次数: 0
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.
NPJ VaccinesImmunology and Microbiology-Immunology
CiteScore
11.90
自引率
4.30%
发文量
146
审稿时长
11 weeks
期刊介绍:
Online-only and open access, npj Vaccines is dedicated to highlighting the most important scientific advances in vaccine research and development.