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在养老院居住的老年人中 COVID-19 疫苗的免疫原性、有效性和安全性:一项真实世界研究。

Immunogenicity, effectiveness and safety of COVID-19 vaccine in older adults living in nursing homes: A real-life study.

机构信息

Department of Internal Medicine, Hospital Quironsalud A Coruña, A Coruña, Spain.

Executive Director, Residencia Dulcinea, Grupo Quirónsalud, Alcázar de San Juan, Ciudad Real, Spain.

出版信息

Rev Esp Geriatr Gerontol. 2023 May-Jun;58(3):125-133. doi: 10.1016/j.regg.2023.02.009. Epub 2023 Mar 6.

DOI:10.1016/j.regg.2023.02.009
PMID:37031072
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9986119/
Abstract

INTRODUCTION

BNT162b2 (BioNTech and Pfizer) is a nucleoside-modified mRNA vaccine that provides protection against SARS-CoV-2 infection and is generally well tolerated. However, data about its efficacy, immunogenicity and safety in people of old age or with underlying chronic conditions are scarce.

PURPOSE

To describe BNT162b2 (BioNTech and Pfizer) COVID-19 vaccine immunogenicity, effectiveness and reactogenicity after complete vaccination (two doses), and immunogenicity and reactogenicity after one booster, in elders residing in nursing homes (NH) and healthy NH workers in real-life conditions.

METHODS

Observational, ambispective, multicenter study. Older adults and health workers were recruited from three nursing homes of a private hospital corporation located in three Spanish cities. The primary vaccination was carried out between January and March 2021. The follow-up was 13 months. Humoral immunity, adverse events, SARS-CoV-2 infections, hospitalizations and deaths were evaluated. Cellular immunity was assessed in a participant subset.

RESULTS

A total of 181 residents (mean age 84.1 years; 89.9% females, Charlson index ≥2: 45%) and 148 members of staff (mean age 45.2 years; 70.2% females) were surveyed (n:329). After primary vaccination of 327 participants, vaccine response in both groups was similar; ≈70% of participants, regardless of the group, had an antibody titer above the cut-off considered currently protective (260BAU/ml). This proportion increased significantly to ≈ 98% after the booster (p<0.0001 in both groups). Immunogenicity was largely determined by a prior history of COVID-19 infection. Twenty residents and 3 workers were tested for cellular immunity. There was evidence of cellular immunity after primary vaccination and after booster. During the study, one resident was hospitalized for SARS-CoV-2. No SARS-CoV-2-related deaths were reported and most adverse events were mild.

CONCLUSIONS

Our results suggest that the BNT162b2 mRNA COVID-19 vaccine is immunogenic, effective and safe in elderly NH residents with underlying chronic conditions.

摘要

简介

BNT162b2(辉瑞/BioNTech)是一种核苷修饰的 mRNA 疫苗,可预防 SARS-CoV-2 感染,且通常具有良好的耐受性。然而,关于其在老年人或患有基础慢性病人群中的疗效、免疫原性和安全性的数据还很缺乏。

目的

描述 BNT162b2(辉瑞/BioNTech)COVID-19 疫苗在真实环境下,完全接种(两剂)后的免疫原性、有效性和不良反应,以及一剂加强针后的免疫原性和不良反应,接种对象为养老院中的老年人和健康的养老院工作人员。

方法

这是一项观察性、前瞻性、多中心研究。从位于西班牙三个城市的一家私立医院集团的三家养老院招募老年人和工作人员。初次接种于 2021 年 1 月至 3 月进行。随访时间为 13 个月。评估了体液免疫、不良事件、SARS-CoV-2 感染、住院和死亡情况。在一个参与者亚组中评估了细胞免疫。

结果

共调查了 181 名居民(平均年龄 84.1 岁;89.9%为女性,Charlson 指数≥2:45%)和 148 名工作人员(平均年龄 45.2 岁;70.2%为女性)(n=329)。在 327 名参与者进行初次接种后,两组的疫苗反应相似;无论组内如何,约 70%的参与者抗体滴度高于当前被认为具有保护作用的临界值(260BAU/ml)。在加强针后,这一比例显著增加至约 98%(两组均 p<0.0001)。免疫原性主要由先前的 COVID-19 感染史决定。20 名居民和 3 名工作人员接受了细胞免疫测试。初次接种和加强针后均有细胞免疫的证据。在研究期间,有 1 名居民因 SARS-CoV-2 住院。未报告与 SARS-CoV-2 相关的死亡病例,大多数不良反应为轻度。

结论

我们的结果表明,BNT162b2 mRNA COVID-19 疫苗在患有基础慢性病的养老院老年人中具有免疫原性、有效性和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2cf/9986119/0f784292fe96/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2cf/9986119/166d11a90ae3/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2cf/9986119/0f784292fe96/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2cf/9986119/166d11a90ae3/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2cf/9986119/0f784292fe96/gr2_lrg.jpg

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