欧洲JCOVDEN单剂疫苗对COVID-19住院治疗的有效性分析DRIVE试验阴性的病例对照研究

IF 4.7 3区医学 Q1 INFECTIOUS DISEASES

Journal of Infection and Public Health Pub Date : 2025-02-11 DOI:10.1016/j.jiph.2025.102700

Chloé Wyndham-Thomas , E. Claire Newbern , Ainara Mira-Iglesias , Akshat Dwivedi , Alejandro Orrico Sánchez , Andrés Antón , Charlotte Martin , Giancarlo Icardi , Irma Casas , Kok Yew Ngew , Laura Drikite , Leonie de Munter , Gerrit Luit ten Kate , Nikki Vroom , Sebastian Baumgartner , Susana Otero-Romero , Xavier Holemans , Kaatje Bollaerts , Nicolas Praet

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引用次数: 0

摘要

jcovden （Ad26.COV2.S）是一种病毒载体疫苗，于2021年初在欧盟获得了用于预防COVID-19的有条件上市许可。我们提出了JCOVDEN单剂量疫苗对COVID-19住院的有效性（VE）估计。MethodsThe id。COVID-19 - VE研究是一项正在进行的欧洲非干预性多中心研究，采用阴性病例对照设计。研究参与者为成人≥ ，年龄18岁，在2021年5月1日至2023年2月28日期间因严重急性呼吸道感染住院。作为整个研究期间的单一测量，VE按风险组、接种疫苗间隔时间（14天至12周、12至25周、25至52周、52周）、SARS-CoV-2变体和日历时间类别进行分层。所有的估计都根据症状发生日期、年龄、性别和预先定义的慢性病数量进行了调整。结果总体而言，VE为55.6% %(95% % CI 23.6；74.2)接种后的中位时间为146天。对于18- 49岁的人群，VE为61.6 %(95 % CI 16.2；82.4), 57.7 %(95 % ci 3.4；50- 64岁为81.5),40.8 %(95% % CI−6.0；66.9)≥ 65岁。最精确的估计是接种疫苗后12至25周的间隔时间(59.2 %[95 % CI 25.0；77.8])和2021年8月1日 - 2021年11月30日(Delta占主导地位；51.2 %[95 % ci 21.7；69.6])。结论JCOVDEN单剂可预防COVID-19住院。它的有效性至少为6个月，在年龄较大的人群中，VE估计相对较低。结果具有低至中等水平的确定性，应谨慎解释。

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Vaccine effectiveness of JCOVDEN single-dose against COVID-19 hospitalisation in Europe: An id.DRIVE test-negative case-control study

Background

JCOVDEN (Ad26.COV2.S), a viral-vector vaccine, was granted conditional marketing authorisation in the European Union for the prevention of COVID-19 in early 2021. We present JCOVDEN single-dose vaccine effectiveness (VE) estimates against COVID-19 hospitalisation.

Methods

The id.DRIVE (previously COVIDRIVE) COVID-19 VE study is an ongoing European non-interventional, multi-centre study with a test-negative case-control design. Study participants were adults ≥ 18 years old, hospitalised with severe acute respiratory infection between 1 May 2021 and 28 February 2023. Estimated as a single measure over the entire study period, VE was stratified by risk group, time since vaccination intervals (14 days-12 weeks, 12-to-25 weeks, 25-to-52 weeks, >52 weeks), SARS-CoV-2 variant and calendar time categories. All estimates were adjusted for symptom-onset date, age, sex, and number of pre-defined chronic conditions.

Results

Overall, VE was 55.6 % (95 % CI 23.6; 74.2) for a median time since vaccination of 146 days. For 18- to 49-year-olds, VE was 61.6 % (95 % CI 16.2; 82.4), 57.7 % (95 % CI 3.4; 81.5) for 50- to-64-years-olds, and 40.8 % (95 % CI −6.0; 66.9) for ≥ 65-year-olds. Most precise estimates were obtained for time since vaccination 12-to- 25-week interval (59.2 % [95 % CI 25.0; 77.8]) and for the calendar time period 1 Aug 2021 −30 Nov 2021 (Delta predominant; 51.2 % [95 % CI 21.7; 69.6]).

Conclusion

The JCOVDEN single-dose protected against COVID-19 hospitalisation. It is effective for at least six months, with VE estimates comparatively lower in the older age groups. Results had low to medium levels of certainty and are to be interpreted with caution.

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来源期刊

Journal of Infection and Public Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH -INFECTIOUS DISEASES

CiteScore

13.10

自引率

1.50%

发文量

203

审稿时长

96 days

期刊介绍： The Journal of Infection and Public Health, first official journal of the Saudi Arabian Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences and the Saudi Association for Public Health, aims to be the foremost scientific, peer-reviewed journal encompassing infection prevention and control, microbiology, infectious diseases, public health and the application of healthcare epidemiology to the evaluation of health outcomes. The point of view of the journal is that infection and public health are closely intertwined and that advances in one area will have positive consequences on the other. The journal will be useful to all health professionals who are partners in the management of patients with communicable diseases, keeping them up to date. The journal is proud to have an international and diverse editorial board that will assist and facilitate the publication of articles that reflect a global view on infection control and public health, as well as emphasizing our focus on supporting the needs of public health practitioners. It is our aim to improve healthcare by reducing risk of infection and related adverse outcomes by critical review, selection, and dissemination of new and relevant information in the field of infection control, public health and infectious diseases in all healthcare settings and the community.