队列资料简介：一项评估 COVID-19 献血人群血清流行率的纵向区域性队列研究——Semaco 研究参与者的基线特征。

Cohort profile: a longitudinal regional cohort study to assess COVID-19 seroprevalence in blood donors - baseline characteristics of the SeMaCo study participants.

机构信息

Institute of Social Medicine and Health Systems Research, University Hospital Magdeburg, Magdeburg, Germany

Institute of Social Medicine and Health Systems Research, University Hospital Magdeburg, Magdeburg, Germany.

出版信息

BMJ Open. 2023 Apr 18;13(4):e068472. doi: 10.1136/bmjopen-2022-068472.

DOI:10.1136/bmjopen-2022-068472

PMID:37072368

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10124278/

Abstract

PURPOSE

The SeMaCo study (Serologische Untersuchungen bei Blutspendern des Großraums Magdeburg auf Antikörper gegen SARS-CoV-2), a prospective, longitudinal cohort study with four survey phases spanning 3-5 months each over a period of 22 months, extends the spectrum of seroepidemiological studies in Germany. We present here a careful characterisation of the initial survey phase of the cohort to provide baseline data on infection incidence and obtained from questionnaires, focussing in particular on the attitude towards COVID-19 vaccinations, the vaccination success and the vaccination acceptance.

PARTICIPANTS

A total of 2195 individual blood donors from the donor pool of the blood donation service of the University Hospital Magdeburg were enrolled in the initial survey phase from 20 January 2021 to 30 April 2021. 2138 participants gave sociodemographic/contact data (51.7% male, mean age 44 years) and 2082 participants answered the vaccination questionnaire.

FINDINGS TO DATE

Out of 2195 participants with antibody results, 1909 (87.0%) were antibody negative. The remaining 286 subjects (13.0%) were either antibody-positive and vaccinated (160/286; 55.9%) or antibody-positive without vaccination information (17/286; 5.9%) or antibody-positive and unvaccinated (109/286; 38.1%). The latter result reflects the rate of true or highly probable SARS-CoV-2 infections in our initial study cohort.

FUTURE PLANS

The study primarily aims to measure the prevalence and long-term kinetics of IgG-antibodies against SARS-CoV-2. Including the baseline, the study foresees four survey periods of 3-4 months each. At each visit, we will assess the blood donors' attitude towards vaccination, the antibody response following vaccination and/or infection, as well as undesired vaccination effects. We aim to test the same participants during the survey periods by repeated invitations for blood donation to ensure a long-term (follow-up) in as many study participants as possible. After the four survey phases, a longitudinal data set will be created that reflects the course of the antibody levels/frequencies as well as the infection and vaccination incidence.

TRIAL REGISTRATION NUMBER

DRKS00023263.

摘要

目的

Semaco 研究（在马格德堡地区献血者中进行的血清学研究，以检测针对 SARS-CoV-2 的抗体）是一项前瞻性、纵向队列研究，共分为四个研究阶段，每个阶段持续 3-5 个月，历时 22 个月，扩展了德国血清流行病学研究的范围。本研究对队列的初始研究阶段进行了仔细描述，提供了感染发生率的基线数据，并从问卷调查中获得了这些数据，重点关注对 COVID-19 疫苗接种的态度、疫苗接种成功率和疫苗接种接受率。

参与者

2021 年 1 月 20 日至 2021 年 4 月 30 日，从马格德堡大学医院献血服务的献血者库中招募了 2195 名个体献血者参加初始调查阶段。2138 名参与者提供了社会人口统计学/联系方式（51.7%为男性，平均年龄 44 岁），2082 名参与者回答了疫苗接种问卷。

截至目前的发现

在有抗体结果的 2195 名参与者中，1909 名（87.0%）抗体阴性。其余 286 名受试者（13.0%）要么抗体阳性且已接种疫苗（160/286；55.9%），要么抗体阳性但无疫苗接种信息（17/286；5.9%），要么抗体阳性且未接种疫苗（109/286；38.1%）。后一种结果反映了我们初始研究队列中真正或高度可能的 SARS-CoV-2 感染率。

未来计划

该研究主要旨在测量针对 SARS-CoV-2 的 IgG 抗体的流行率和长期动力学。包括基线在内，该研究预计有四个为期 3-4 个月的调查阶段。在每次访问中，我们将评估献血者对疫苗接种的态度、接种疫苗/感染后的抗体反应以及不良的疫苗接种效果。我们的目标是通过多次邀请献血来检测同一批参与者，以确保在尽可能多的研究参与者中进行长期（随访）。在四个调查阶段之后，将创建一个纵向数据集，反映抗体水平/频率以及感染和疫苗接种发生率的变化。