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18 岁及以上成年人中口服雾化双价腺病毒 5 型载体 COVID-19 疫苗和 B.1.1.529 变异腺病毒 5 型载体 COVID-19 疫苗异源加强免疫的安全性和免疫原性：一项随机、双盲、平行对照试验。

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.

机构信息

Expanded Program on Immunization, Chongqing Center for Disease Control and Prevention, Chongqing, People's Republic of China.

Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, People's Republic of China.

出版信息

Emerg Microbes Infect. 2024 Dec;13(1):2281355. doi: 10.1080/22221751.2023.2281355. Epub 2023 Dec 30.

DOI:10.1080/22221751.2023.2281355
PMID:37933089
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11025474/
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 (5×10viral particles) and B.1.1.529 variant (5×10viral 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 (5×10viral 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.

摘要

接种能够诱导广谱免疫应答的疫苗策略对于增强对 SARS-CoV-2 变体的保护至关重要。我们进行了一项随机、双盲、平行对照试验，以评估吸入式 5×10 病毒颗粒二价（5×10 病毒颗粒）和 B.1.1.529 变体腺病毒 5 型（Ad5）载体 COVID-19 疫苗的安全性和免疫原性。451 名符合条件的 18 岁及以上成年人已接种三剂灭活 COVID-19 疫苗，随机分为三组，每组 150 人，分别吸入一剂 B.1.1.529 变体 Ad5 载体 COVID-19 疫苗（Ad5-nCoVO-IH 组）、二价 Ad5 载体 COVID-19 疫苗（Ad5-nCoV/O-IH 组）或 5×10 病毒颗粒 Ad5 载体 COVID-19 疫苗（Ad5-nCoV-IH 组）。报告称，Ad5-nCoVO-IH 组有 37 名（24.67%）参与者、Ad5-nCoV/O-IH 组有 28 名（18.54%）参与者、Ad5-nCoV-IH 组有 26 名（17.33%）参与者出现不良反应，主要为轻度至中度口干、口咽疼痛、头痛、肌痛、咳嗽、发热和疲劳。未报告与疫苗相关的严重不良事件。试验疫苗具有免疫原性，接种后 28 天，Ad5-nCoV/O-IH（43.70）和 Ad5-nCoV-IH（29.25）对奥密克戎 BA.1 的中和抗体几何平均滴度（GMT）差异有统计学意义（P=0.0238）。Ad5-nCoVO-IH、Ad5-nCoV/O-IH 和 Ad5-nCoV-IH 组 BA.1 中和抗体的血清转化率分别为 56.00%、59.60%和 48.67%，组间差异无统计学意义。总体而言，试验疫苗在成年人中表现出良好的安全性和耐受性，除了诱导体液和细胞免疫应答以抵御 SARS-CoV-2 变体外，还能高度有效地诱导黏膜免疫。 试验注册：Chictr.org 标识符：ChiCTR2200063996。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/309d8aaf96be/TEMI_A_2281355_F0006_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/eb14fa0f62d4/TEMI_A_2281355_F0001_OB.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/0869d02dbccf/TEMI_A_2281355_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/f727e32227fd/TEMI_A_2281355_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/27ba5bc465f7/TEMI_A_2281355_F0004_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/a7e120b21505/TEMI_A_2281355_F0005_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/309d8aaf96be/TEMI_A_2281355_F0006_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/eb14fa0f62d4/TEMI_A_2281355_F0001_OB.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/0869d02dbccf/TEMI_A_2281355_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/f727e32227fd/TEMI_A_2281355_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/27ba5bc465f7/TEMI_A_2281355_F0004_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/a7e120b21505/TEMI_A_2281355_F0005_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957a/11025474/309d8aaf96be/TEMI_A_2281355_F0006_OC.jpg

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本文引用的文献

[1]
Repeated Omicron exposures override ancestral SARS-CoV-2 immune imprinting.

Nature. 2024-1

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Safety, immunogenicity and protection of heterologous boost with an aerosolised Ad5-nCoV after two-dose inactivated COVID-19 vaccines in adults: a multicentre, open-label phase 3 trial.

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Front Immunol. 2023

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