Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app: a prospective, community-based, nested, case-control study.
Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app: a prospective, community-based, nested, case-control study.
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DOI：
10.1016/s1473-3099(21)00460-6
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发表时间：
2022-01
期刊：
影响因子：
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通讯作者：
Steves CJ
中科院分区：
文献类型：
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作者：
Antonelli M;Penfold RS;Merino J;Sudre CH;Molteni E;Berry S;Canas LS;Graham MS;Klaser K;Modat M;Murray B;Kerfoot E;Chen L;Deng J;Österdahl MF;Cheetham NJ;Drew DA;Nguyen LH;Pujol JC;Hu C;Selvachandran S;Polidori L;May A;Wolf J;Chan AT;Hammers A;Duncan EL;Spector TD;Ourselin S;Steves CJ
COVID-19疫苗在临床试验中显示出优异的疗效，在现实数据中也显示出有效性，但仍有部分人在接种疫苗后感染了SARS-CoV-2。本研究旨在确定疫苗接种后SARS-CoV-2感染的危险因素，并描述疫苗接种后疾病的特征。这项前瞻性、以社区为基础、巢式、病例对照研究使用了自我报告的数据（例如，人口统计数据，地理位置，健康风险因素，以及COVID-19检测结果，症状和疫苗接种）来自英国的成人（≥18岁）COVID症状研究移动的手机应用程序的用户。对于风险因素分析，病例在12月8日之间接受了第一剂或第二剂COVID-19疫苗，于二零二零年及二零二一年七月四日;在首次接种疫苗后至少14天（但在第二次接种疫苗前;病例1）或在第二次接种疫苗后至少7天（病例2）进行COVID-19检测呈阳性;且在接种疫苗前未进行阳性检测。选择了两个对照组（在接种疫苗前也没有检测出SARS-CoV-2阳性）：第一次接种疫苗后至少14天但在第二次接种疫苗前报告阴性检测的使用者（对照组1）和第二次接种疫苗后至少7天报告阴性检测的使用者（对照组2）。对照组1和对照组2分别与病例1和病例2按接种后检测日期、卫生保健工作者身份和性别进行匹配（1：1）。在疾病特征分析中，我们从病例1和病例2中选择了参与者，他们在SARS-CoV-2检测呈阳性后至少连续使用了14天（分别为病例3和病例4）。对照组3和对照组4是未接种疫苗的参与者，报告SARS-CoV-2检测呈阳性，在检测后至少连续14天使用该应用程序，并分别与病例3和病例4匹配（1：1），根据阳性检测日期，卫生保健工作者状态，性别，体重指数（BMI）和年龄。我们使用单变量logistic回归模型（调整年龄，BMI和性别）来分析风险因素与疫苗接种后感染之间的关联，以及个体症状，总体疾病持续时间和疾病严重程度与疫苗接种状态之间的关联。在2020年12月8日至2021年7月4日期间，1 240 009名COVID症状研究应用程序用户报告了第一剂疫苗，其中6030人（0.5%）随后检测为SARS-CoV-2阳性（病例1），971 504人报告了第二剂疫苗，其中2370人（0.2%）随后检测为SARS-CoV-2阳性（病例2）。在危险因素分析中，老年人的虚弱与接种后感染有关首次接种疫苗后（≥60岁）（比值比[OR] 1.93，95% CI 1.50 ~ 2.48; p<0.0001），生活在高度贫困地区的个体在首次接种疫苗后感染的几率增加（OR 1.11，95% CI 1.01 - 1.23; p= 0.039）。没有肥胖的个体（BMI <30 kg/m2）在首次接种疫苗后感染的几率较低（OR 0.84，95% CI 0.75 - 0.94; p= 0.0030）。对于疾病特征分析，病例1的3825名使用者被纳入病例3，病例2的906名使用者被纳入病例4。接种疫苗（与未接种疫苗相比）与第一次或第二次接种后第一周住院或出现5种以上症状的几率降低以及第二次接种后出现长期（≥28天）症状相关。几乎所有的症状在接种疫苗的感染者中报告的频率低于未接种疫苗的感染者，接种疫苗的参与者更有可能完全无症状，特别是如果他们是60岁或以上。为了尽量减少SARS-CoV-2感染，必须针对高危人群，努力提高疫苗的有效性和感染控制措施。我们的研究结果可能支持在疫苗接种后放松身体距离和其他个人保护措施的谨慎态度，特别是在体弱的老年人和生活在更贫困地区的个人周围，即使这些人接种了疫苗，也可能对加强疫苗接种等策略产生影响。ZOE、英国政府卫生和社会保健部、威康信托基金会、英国工程和物理科学研究理事会、英国研究与创新伦敦医学成像和人工智能中心、英国国家健康研究所、英国医学研究理事会、英国心脏基金会和阿尔茨海默氏症协会。
COVID-19 vaccines show excellent efficacy in clinical trials and effectiveness in real-world data, but some people still become infected with SARS-CoV-2 after vaccination. This study aimed to identify risk factors for post-vaccination SARS-CoV-2 infection and describe the characteristics of post-vaccination illness. This prospective, community-based, nested, case-control study used self-reported data (eg, on demographics, geographical location, health risk factors, and COVID-19 test results, symptoms, and vaccinations) from UK-based, adult (≥18 years) users of the COVID Symptom Study mobile phone app. For the risk factor analysis, cases had received a first or second dose of a COVID-19 vaccine between Dec 8, 2020, and July 4, 2021; had either a positive COVID-19 test at least 14 days after their first vaccination (but before their second; cases 1) or a positive test at least 7 days after their second vaccination (cases 2); and had no positive test before vaccination. Two control groups were selected (who also had not tested positive for SARS-CoV-2 before vaccination): users reporting a negative test at least 14 days after their first vaccination but before their second (controls 1) and users reporting a negative test at least 7 days after their second vaccination (controls 2). Controls 1 and controls 2 were matched (1:1) with cases 1 and cases 2, respectively, by the date of the post-vaccination test, health-care worker status, and sex. In the disease profile analysis, we sub-selected participants from cases 1 and cases 2 who had used the app for at least 14 consecutive days after testing positive for SARS-CoV-2 (cases 3 and cases 4, respectively). Controls 3 and controls 4 were unvaccinated participants reporting a positive SARS-CoV-2 test who had used the app for at least 14 consecutive days after the test, and were matched (1:1) with cases 3 and 4, respectively, by the date of the positive test, health-care worker status, sex, body-mass index (BMI), and age. We used univariate logistic regression models (adjusted for age, BMI, and sex) to analyse the associations between risk factors and post-vaccination infection, and the associations of individual symptoms, overall disease duration, and disease severity with vaccination status. Between Dec 8, 2020, and July 4, 2021, 1 240 009 COVID Symptom Study app users reported a first vaccine dose, of whom 6030 (0·5%) subsequently tested positive for SARS-CoV-2 (cases 1), and 971 504 reported a second dose, of whom 2370 (0·2%) subsequently tested positive for SARS-CoV-2 (cases 2). In the risk factor analysis, frailty was associated with post-vaccination infection in older adults (≥60 years) after their first vaccine dose (odds ratio [OR] 1·93, 95% CI 1·50–2·48; p<0·0001), and individuals living in highly deprived areas had increased odds of post-vaccination infection following their first vaccine dose (OR 1·11, 95% CI 1·01–1·23; p=0·039). Individuals without obesity (BMI <30 kg/m2) had lower odds of infection following their first vaccine dose (OR 0·84, 95% CI 0·75–0·94; p=0·0030). For the disease profile analysis, 3825 users from cases 1 were included in cases 3 and 906 users from cases 2 were included in cases 4. Vaccination (compared with no vaccination) was associated with reduced odds of hospitalisation or having more than five symptoms in the first week of illness following the first or second dose, and long-duration (≥28 days) symptoms following the second dose. Almost all symptoms were reported less frequently in infected vaccinated individuals than in infected unvaccinated individuals, and vaccinated participants were more likely to be completely asymptomatic, especially if they were 60 years or older. To minimise SARS-CoV-2 infection, at-risk populations must be targeted in efforts to boost vaccine effectiveness and infection control measures. Our findings might support caution around relaxing physical distancing and other personal protective measures in the post-vaccination era, particularly around frail older adults and individuals living in more deprived areas, even if these individuals are vaccinated, and might have implications for strategies such as booster vaccinations. ZOE, the UK Government Department of Health and Social Care, the Wellcome Trust, the UK Engineering and Physical Sciences Research Council, UK Research and Innovation London Medical Imaging and Artificial Intelligence Centre for Value Based Healthcare, the UK National Institute for Health Research, the UK Medical Research Council, the British Heart Foundation, and the Alzheimer's Society.