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, Chin Voon K, Teo Jau S, Lim Teck O, Zhu Tao, Gou Jinbo, Ng Sharon S M
Centre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.
Clinical Operations Center, CanSino Biologics Inc., Tianjin, China.
NPJ Vaccines. 2024 Oct 31;9(1):209. doi: 10.1038/s41541-024-01003-x.
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.
这项3期、观察者盲法、非劣效性随机试验（ClinicalTrials.gov：NCT05517642）于2022年9月至2023年5月在马来西亚的三个地点进行，纳入了540名之前已接种三剂新冠疫苗的成年人。参与者按1:1随机分组，分别接受一剂吸入式重组新冠疫苗（Ad5-nCoV-IH）或肌肉注射托珠单抗（BNT-IM）。该研究评估了针对SARS-CoV-2变异株的安全性、疫苗效力（VE）和免疫原性。主要结局是抗刺突蛋白受体结合域（S-RBD IgG）抗体的非劣效性，几何平均浓度（GMC）比值的97.5%置信区间下限>0.67。Ad5-nCoV-IH的免疫原性低于BNT-IM，GMC比值为0.22，血清转化率差异为-71.91%。与BNT-IM（64.68%）相比，Ad5-nCoV-IH的药物不良反应（ADR）发生率较低（39.26%）。未报告与疫苗相关的严重不良事件。两种疫苗对新冠变异株的效力相当。本研究由天津市生物医学科技重大项目资助。
