Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial.

IF 8.4 2区医学 Q1 IMMUNOLOGY Emerging Microbes & Infections Pub Date : 2024-12-01 Epub Date: 2023-12-30 DOI:10.1080/22221751.2023.2281355

Jia-Wei Xu, Bu-Sen Wang, Ping Gao, Hai-Tao Huang, Fei-Yu Wang, Wei Qiu, Yuan-Yuan Zhang, Yu Xu, Jin-Bo Gou, Lin-Ling Yu, Xuan Liu, Rui-Jie Wang, Tao Zhu, Li-Hua Hou, Qing- Wang

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Abstract

Vaccination strategies that can induce a broad spectrum immune response are important to enhance protection against SARS-CoV-2 variants. We conducted a randomized, double-blind and parallel controlled trial to evaluate the safety and immunogenicity of the bivalent (5×10¹⁰viral particles) and B.1.1.529 variant (5×10¹⁰viral particles) adenovirus type-5 (Ad5) vectored COVID-19 vaccines administrated via inhalation. 451 eligible subjects aged 18 years and older who had been vaccinated with three doses inactivated COVID-19 vaccines were randomly assigned to inhale one dose of either B.1.1.529 variant Ad5 vectored COVID-19 vaccine (Ad5-nCoVO-IH group, N=150), bivalent Ad5 vectored COVID-19 vaccine (Ad5-nCoV/O-IH group, N=151), or Ad5 vectored COVID-19 vaccine (5×10¹⁰viral particles; Ad5-nCoV-IH group, N=150). Adverse reactions reported by 37 (24.67%) participants in the Ad5-nCoVO-IH group, 28 (18.54%) in the Ad5-nCoV/O-IH group, and 26 (17.33%) in the Ad5-nCoV-IH group with mainly mild to moderate dry mouth, oropharyngeal pain, headache, myalgia, cough, fever and fatigue. No serious adverse events related to the vaccine were reported. Investigational vaccines were immunogenic, with significant difference in the GMTs of neutralizing antibodies against Omicron BA.1 between Ad5-nCoV/O-IH (43.70) and Ad5-nCoV-IH (29.25) at 28 days after vaccination (P=0.0238). The seroconversion rates of neutralizing antibodies against BA.1 in Ad5-nCoVO-IH, Ad5-nCoV/O-IH, and Ad5-nCoV-IH groups were 56.00%, 59.60% and 48.67% with no significant difference among the groups. Overall, the investigational vaccines were demonstrated to be safe and well tolerated in adults, and was highly effective in inducing mucosal immunities in addition to humoral and cellular immune responses defending against SARS-CoV-2 variants.Trial registration: Chictr.org identifier: ChiCTR2200063996.

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口服雾化二价腺病毒5型载体新冠肺炎疫苗和B.1.1.529变异腺病毒5号载体新冠肺炎疫苗对18岁及以上成年人异源增强的安全性和免疫原性：一项随机、双盲、平行对照试验。

可以诱导广谱免疫反应的疫苗接种策略对于增强对严重急性呼吸系统综合征冠状病毒2型变异株的保护非常重要。我们进行了一项随机、双盲和平行对照试验，以评估吸入接种的二价（5×1010病毒颗粒）和B.1.1.529变体（5×1010病毒颗粒）5型腺病毒（Ad5）载体新冠肺炎疫苗的安全性和免疫原性。总共451名18岁及以上接种过三剂新冠肺炎灭活疫苗的合格受试者被随机分配吸入一剂B.1.1.529变体Ad5载体新冠肺炎疫苗（Ad5-nCoVO-IH组，N=150）、二价Ad5载体新冠肺炎疫苗（Ad3-nCoV/O-IH组，N=151）、，或Ad5载体新冠肺炎疫苗（5×1010个病毒颗粒；Ad5-nCoV-IH组，N=150）。主要安全性结果包括Ad5-nCoVO IH组37名（24.67%）参与者、Ad5-nCoV/O-IH组28名（18.54%）参与者和Ad5-nCoV-IH组26名（17.33%）参与者报告的不良反应，主要表现为轻度至中度口干、口咽疼痛、头痛、肌痛、咳嗽、发烧和疲劳。未报告与疫苗相关的严重不良事件。所有研究疫苗都是免疫原性的，在接种后28天，Ad5-nCoV/O-IH（43.70）和Ad5-nCoV IH（29.25）之间的针对奥密克戎BA.1的中和抗体GMT差异具有统计学意义（P=0.0238），59.60%和48.67%，差异无统计学意义。总的来说，研究疫苗在成年人中被证明是安全和耐受性良好的，并且在诱导粘膜免疫以及防御严重急性呼吸系统综合征冠状病毒2型变异株的体液和细胞免疫反应方面非常有效。试验注册：Chictr.org标识符：ChiCTR220063996。

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来源期刊

Emerging Microbes & Infections IMMUNOLOGY-MICROBIOLOGY

CiteScore

26.20

自引率

2.30%

发文量

276

审稿时长

20 weeks

期刊介绍： Emerging Microbes & Infections is a peer-reviewed, open-access journal dedicated to publishing research at the intersection of emerging immunology and microbiology viruses. The journal's mission is to share information on microbes and infections, particularly those gaining significance in both biological and clinical realms due to increased pathogenic frequency. Emerging Microbes & Infections is committed to bridging the scientific gap between developed and developing countries. This journal addresses topics of critical biological and clinical importance, including but not limited to: - Epidemic surveillance - Clinical manifestations - Diagnosis and management - Cellular and molecular pathogenesis - Innate and acquired immune responses between emerging microbes and their hosts - Drug discovery - Vaccine development research Emerging Microbes & Infections invites submissions of original research articles, review articles, letters, and commentaries, fostering a platform for the dissemination of impactful research in the field.