先前接种两剂科兴疫苗的个体中，经口服雾化 Ad5-nCoV 异源加强后抗体持久性和安全性：一项随机对照试验的 12 个月分析。

Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial.

机构信息

School of Public Health, Southeast University, Nanjing, People's Republic of China.

National Health Commission (NHC) Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, People's Republic of China.

出版信息

Emerg Microbes Infect. 2023 Dec;12(1):2155251. doi: 10.1080/22221751.2022.2155251.

DOI:10.1080/22221751.2022.2155251

PMID:36503413

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10519268/

Abstract

Antibody persistence and safety up to 12 months of heterologous orally administered adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in individuals who were primed with two-dose inactivated SARS-CoV-2 vaccine (CoronaVac) previously, has not been reported yet. This randomized, open-label, single-centre trial included Chinese adults who have received two-dose CoronaVac randomized to low-dose or high-dose aerosolised Ad5-nCoV group, or CoronaVac group. In this report, we mainly evaluated the geometric mean titres (GMTs) of neutralizing antibodies (NAbs) against live wild-type SARS-CoV-2 virus and omicron BA.4/5 pseudovirus at 12 months after the booster dose and the incidence of serious adverse events (SAEs) till month 12. Of 419 participants, all were included in the safety analysis and 120 (28.64%) were included in the immunogenicity analysis. Serum NAb GMT against live wild-type SARS-CoV-2 was 204.36 (95% CI 152.91, 273.14) in the low-dose group and 171.38 (95% CI 121.27, 242.19) in the high-dose group at month 12, significantly higher than the GMT in the CoronaVac group (8.00 [95% CI 4.22, 15.17], < 0.0001). Serum NAb GMT against omicron BA.4/5 pseudovirus was 40.97 (95% CI 30.15, 55.67) in the low-dose group and 35.08 (95% CI 26.31, 46.77) in the high-dose group at month 12, whereas the GMT in the CoronaVac group was below the lower limit of detection. No vaccine-related SAEs were observed. Orally administered aerosolised Ad5-nCoV following two-dose CoronaVac priming has a good safety profile and is persistently more immunogenic than three-dose CoronaVac within 12 months after the booster dose.Trial registration: ClinicalTrials.gov identifier: NCT05043259..

摘要

在先前已接种两剂灭活 SARS-CoV-2 疫苗（科兴疫苗）的个体中，异源口服腺病毒 5 型载体 COVID-19 疫苗（Ad5-nCoV）的抗体持久性和安全性可长达 12 个月，但目前尚未有相关报道。这项随机、开放标签、单中心试验纳入了已接种两剂科兴疫苗的中国成年人，他们被随机分配至低剂量或高剂量雾化 Ad5-nCoV 组，或科兴疫苗组。在本报告中，我们主要评估了加强针后 12 个月时针对活野生型 SARS-CoV-2 病毒和 omicron BA.4/5 假病毒的中和抗体（NAb）的几何平均滴度（GMT），以及到第 12 个月时严重不良事件（SAE）的发生率。在 419 名参与者中，所有人均纳入安全性分析，120 人（28.64%）纳入免疫原性分析。低剂量组和高剂量组在第 12 个月时针对活野生型 SARS-CoV-2 的血清 NAb GMT 分别为 204.36（95%CI 152.91，273.14）和 171.38（95%CI 121.27，242.19），显著高于科兴疫苗组（8.00 [95%CI 4.22，15.17]，<0.0001）。低剂量组和高剂量组在第 12 个月时针对 omicron BA.4/5 假病毒的血清 NAb GMT 分别为 40.97（95%CI 30.15，55.67）和 35.08（95%CI 26.31，46.77），而科兴疫苗组的 GMT 低于检测下限。未观察到与疫苗相关的 SAE。在两剂科兴疫苗接种后，口服雾化 Ad5-nCoV 具有良好的安全性，并且在加强针后 12 个月内比三剂科兴疫苗更具免疫原性。临床试验注册：ClinicalTrials.gov 标识符：NCT05043259。