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雾化 Ad5-nCoV 增强免疫在新冠灭活疫苗接种者中引发了强烈的免疫反应。

Boosting with an aerosolized Ad5-nCoV elicited robust immune responses in inactivated COVID-19 vaccines recipients.

机构信息

Beijing Institute of Biotechnology, Beijing, China.

Health Service Department of the Guard Bureau of the General Office of the Central Committee of the Communist Party of China, Beijing, China.

出版信息

Front Immunol. 2023 Oct 4;14:1239179. doi: 10.3389/fimmu.2023.1239179. eCollection 2023.

Abstract

INTRODUCTION

The SARS-CoV-2 Omicron variant has become the dominant SARS-CoV-2 variant and exhibits immune escape to current COVID-19 vaccines, the further boosting strategies are required.

METHODS

We have conducted a non-randomized, open-label and parallel-controlled phase 4 trial to evaluate the magnitude and longevity of immune responses to booster vaccination with intramuscular adenovirus vectored vaccine (Ad5-nCoV), aerosolized Ad5-nCoV, a recombinant protein subunit vaccine (ZF2001) or homologous inactivated vaccine (CoronaVac) in those who received two doses of inactivated COVID-19 vaccines.

RESULTS

The aerosolized Ad5-nCoV induced the most robust and long-lasting neutralizing activity against Omicron variant and IFNg T-cell response among all the boosters, with a distinct mucosal immune response. SARS-CoV-2-specific mucosal IgA response was substantially generated in subjects boosted with the aerosolized Ad5-nCoV at day 14 post-vaccination. At month 6, participants boosted with the aerosolized Ad5-nCoV had remarkably higher median titer and seroconversion of the Omicron BA.4/5-specific neutralizing antibody than those who received other boosters.

DISCUSSION

Our findings suggest that aerosolized Ad5-nCoV may provide an efficient alternative in response to the spread of the Omicron BA.4/5 variant.

CLINICAL TRIAL REGISTRATION

https://www.chictr.org.cn/showproj.html?proj=152729, identifier ChiCTR2200057278.

摘要

简介

SARS-CoV-2 的奥密克戎变体已成为主要的 SARS-CoV-2 变体,并对当前的 COVID-19 疫苗表现出免疫逃逸,因此需要进一步的增强策略。

方法

我们进行了一项非随机、开放性、平行对照的 4 期试验,以评估肌肉内腺病毒载体疫苗(Ad5-nCoV)、雾化 Ad5-nCoV、重组蛋白亚单位疫苗(ZF2001)或同源灭活疫苗(CoronaVac)作为加强针在接种两剂灭活 COVID-19 疫苗的人群中引起的免疫反应的幅度和持久性。

结果

雾化 Ad5-nCoV 在所有加强针中诱导了针对奥密克戎变体的最强大和最持久的中和活性以及 IFNγ T 细胞反应,并具有明显的粘膜免疫反应。在接种雾化 Ad5-nCoV 后的第 14 天,受试者中产生了大量的 SARS-CoV-2 特异性粘膜 IgA 反应。在 6 个月时,与接受其他加强针的参与者相比,接受雾化 Ad5-nCoV 加强针的参与者对奥密克戎 BA.4/5 特异性中和抗体的中位滴度和血清转化率显著更高。

讨论

我们的研究结果表明,雾化 Ad5-nCoV 可能是应对奥密克戎 BA.4/5 变体传播的有效替代方案。

临床试验注册

https://www.chictr.org.cn/showproj.html?proj=152729,标识符 ChiCTR2200057278。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c385/10585368/16a0c6871d67/fimmu-14-1239179-g001.jpg

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