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

IF 6.9 1区 医学 Q1 IMMUNOLOGY
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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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.

气雾化 Ad5-nCoV COVID-19 疫苗在非劣效性随机对照试验中的安全性、有效性和免疫原性。
该3期观察盲非劣效性随机试验(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,共有540名成人参加了该试验,他们之前接种过3剂COVID-19疫苗。参与者以1:1的比例随机接受一剂吸入式重组COVID-19疫苗(Ad5-nCoV-IH)或肌肉注射妥嗪那敏(BNT-IM)。该研究评估了针对 SARS-CoV-2 变体的安全性、疫苗效力 (VE) 和免疫原性。主要结果是抗尖峰蛋白受体结合域(S-RBD IgG)抗体的非劣效性,几何平均浓度(GMC)比值大于 0.67 的置信区间下限为 97.5%。Ad5-nCoV-IH 的免疫原性低于 BNT-IM,几何平均浓度比为 0.22,血清转换率差为 -71.91%。Ad5-nCoV-IH 的药物不良反应(ADRs)发生率(39.26%)低于 BNT-IM(64.68%)。没有与疫苗相关的严重不良反应报告。两种疫苗对COVID-19变种的效力相当。本研究由天津市生物医药科技重大专项资助。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
NPJ Vaccines
NPJ Vaccines Immunology 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.
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