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异源 COVID-19 疫苗第三剂接种后在完全接种灭活疫苗的参与者中的反应原性、免疫原性和体液免疫应答动态。

Reactogenicity, immunogenicity, and humoral immune response dynamics after the third dose of heterologous COVID-19 vaccines in participants fully vaccinated with inactivated vaccine.

机构信息

Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand.

Center of Learning and Research in Celebration of HRH Princess Chulabhorn's 60th Birthday Anniversary, Chulabhorn Royal Academy, Bangkok, Thailand.

出版信息

Expert Rev Vaccines. 2022 Dec;21(12):1873-1881. doi: 10.1080/14760584.2022.2099380. Epub 2022 Jul 13.

Abstract

INTRODUCTION

Immunogenicity after the CoronaVac vaccine remains uncertain, especially regarding infections with the coronavirus variants of concern and waning immunity.

METHODS

This was a single-center, open-label clinical trial designed to assess the immunogenicity and safety of BBIBP-CorV, AZD1222, or BNT162b2 as the third vaccination. The key eligible criteria were individuals at least 18 years old who were fully vaccinated with two doses of CoronaVac vaccine for 2-4 months. The primary endpoint was the ratio of the geometric mean concentration (GMC) of the total anti-receptor binding domain (RBD) antibody post-vaccination compared with that pre-vaccination. The secondary endpoint was reactogenicity within 7 days.

RESULTS

Forty-one participants received AZD1222, 40 received BBIBP-CorV, and 40 received BNT162b2. The GMC of anti-RBD antibody at 2 weeks post-vaccination was 31,138.67 binding antibody units (BAU)/mL for BNT162b2, 6,412.10 BAU/mL for AZD1222, and 1,092.7 BAU/mL for BBIBP-CorV. Compared with pre-vaccination, the ratio of anti-RBD concentration was 690.24 for BNT162b2, 130.02 for AZD1222, and 17.79 for BBIBP-CorV. No potentially life-threatening adverse reaction were observed within 7 days.

CONCLUSION

A third vaccination with the heterologous vaccine, BBIBP-CorV, AZD1222, or BNT162b2, can elicit a robust immune response, without serious adverse events in participants fully vaccinated with the CoronaVac vaccine.

摘要

简介

科兴疫苗接种后的免疫原性仍不确定,尤其是在感染关注的冠状病毒变体和免疫减弱方面。

方法

这是一项单中心、开放性临床试验,旨在评估 BBIBP-CorV、AZD1222 或 BNT162b2 作为第三剂疫苗的免疫原性和安全性。主要入选标准为至少 18 岁、已完成两剂科兴疫苗接种且距第二剂接种后 2-4 个月的个体。主要终点是接种后与接种前相比,总受体结合域(RBD)抗体的几何平均浓度(GMC)比值。次要终点为 7 天内的不良反应。

结果

41 名参与者接种了 AZD1222,40 名接种了 BBIBP-CorV,40 名接种了 BNT162b2。接种后 2 周时,BNT162b2、AZD1222 和 BBIBP-CorV 的抗 RBD 抗体 GMC 分别为 31138.67 结合抗体单位(BAU)/毫升、6412.10 BAU/ml 和 1092.7 BAU/ml。与接种前相比,抗 RBD 浓度比值分别为 BNT162b2 组的 690.24、AZD1222 组的 130.02 和 BBIBP-CorV 组的 17.79。接种后 7 天内未观察到有生命危险的不良反应。

结论

在已完全接种科兴疫苗的参与者中,接种第三剂异源疫苗(BBIBP-CorV、AZD1222 或 BNT162b2)可引起强烈的免疫反应,且无严重不良事件。

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