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法国新冠病毒疫苗研究招募的全国性平台:Covireivac 志愿者的特征。

A national platform for Covid-19 vaccine studies recruitment in France: Covireivac volunteer's characteristics.

机构信息

CIC Cochin Pasteur, Hôpital Cochin, Assistance Publique Hôpitaux de Paris, Paris, France.

Innovative Clinical Research Network in Vaccinology (I-REIVAC), F-CRIN, Paris, France.

出版信息

Hum Vaccin Immunother. 2022 Nov 30;18(6):2109364. doi: 10.1080/21645515.2022.2109364. Epub 2022 Aug 26.

Abstract

During the Covid-19 pandemic, the urgent need for safe and effective vaccines has led to many vaccine trials, implying fast and extensive recruitment of volunteers. In France, until 2020, vaccine clinical research participants were usually recruited locally, through center-based pools of volunteers, and local communication plans. Covireivac is a French public online platform launched on 10/01/2020 that enables national, large-scale recruitment of volunteers for Covid-19 vaccine studies. On the Covireivac website, all adult participants registered online, gave their informed consent, and filled out two online forms with information on their identity, health status (comorbidities, treatments), and known exposure to SARS-CoV-2. Since July 2021, volunteers could mention if their children are interested in participating in a Covid-19 vaccine trial. The objective of this work is to describe Covireivac's volunteer characteristics registered from 10/01/2020 to 11/02/2022. To identify independent volunteer characteristics associated with a period of registration we performed a multivariate logistic regression. Among 54,424 registrations, 52,391 (96%) were analysed; 61% were male ( = 31,893), median age was 50 y; 13% ( = 6586) were healthcare workers. At registration, 15,879 volunteers (33%) reported at least one comorbidity, among whom 16% ( = 7349) were obese and 17% ( = 8346) had hypertension. Most volunteers registered during the first month ( = 35,876, 66%). The Covireivac platform allowed quick and large recruitment of potential volunteers for Covid-19 vaccine trials and could be used on a larger scale for vaccine trials in France. It could facilitate recruitment in vaccine trials and provide sponsors with better visibility of the recruitment capacities of clinical research centers.

摘要

在 COVID-19 大流行期间,对安全有效的疫苗的迫切需求导致了许多疫苗试验,这意味着志愿者的快速广泛招募。在法国,直到 2020 年,疫苗临床研究参与者通常通过当地的志愿者中心池和当地的沟通计划在当地招募。Covireivac 是一个法国公共在线平台,于 2020 年 1 月 10 日推出,可用于全国范围内大规模招募 COVID-19 疫苗研究志愿者。在 Covireivac 网站上,所有成年在线注册的参与者都给予了他们的知情同意,并填写了两份在线表格,其中包含他们的身份、健康状况(合并症、治疗)和已知的 SARS-CoV-2 暴露信息。自 2021 年 7 月以来,志愿者可以提及他们的孩子是否有兴趣参加 COVID-19 疫苗试验。这项工作的目的是描述从 2020 年 1 月 10 日至 2022 年 11 月 2 日在 Covireivac 上注册的志愿者的特征。为了确定与注册期间相关的独立志愿者特征,我们进行了多变量逻辑回归分析。在 54424 次注册中,分析了 52391 次(96%);61%为男性(=31893),中位年龄为 50 岁;13%(=6586)为卫生保健工作者。在注册时,15879 名志愿者(33%)报告至少有一种合并症,其中 16%(=7349)为肥胖,17%(=8346)为高血压。大多数志愿者在第一个月(=35876,66%)注册。Covireivac 平台允许快速大规模招募 COVID-19 疫苗试验的潜在志愿者,并且可以在法国更大范围内用于疫苗试验。它可以促进疫苗试验的招募,并为赞助商提供更好的临床研究中心招募能力的可见度。

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