COVID-19 vaccine effectiveness among people living with and without HIV in South Carolina, USA: protocol of a population-based cohort study.
COVID-19 vaccine effectiveness among people living with and without HIV in South Carolina, USA: protocol of a population-based cohort study.
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DOI：
10.1136/bmjopen-2022-067095
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发表时间：
2022-08-23
期刊：
影响因子：
2.9
通讯作者：
Li, Xiaoming
中科院分区：
文献类型：
--
作者：
Yang Xueying;Zhang, Jiajia;Olatosi, Bankole;Weissman, Sharon;Li, Xiaoming
尽管新冠肺炎疫苗有效地防止了严重的新冠肺炎后果，但一小部分完全接种疫苗的人会出现症状或无症状的感染SARS-CoV-2，这被称为“突破新冠肺炎”。艾滋病毒携带者似乎有更高的风险出现严重的新冠肺炎结果，然而，由于现实世界中对这一人群的研究努力有限，新冠肺炎疫苗在这一人群中的有效性仍不清楚。这项研究旨在描述和比较长寿人群和非长寿人群在新冠肺炎方面取得的突破性进展(如患病率和疾病严重程度)，并检查艾滋病毒标志物是否在长寿人群中对新冠肺炎疫苗有效性起作用。这项队列研究将合并来自南卡罗来纳州(SC)多个数据源的电子健康记录数据，包括从全州增强的艾滋病毒/艾滋病报告系统确定的“艾滋病毒队列”(n=12 203)，来自全州免疫在线网络的提供患者级免疫记录的“疫苗队列”(n=~171万 )，以及包括所有接受新冠肺炎检测的个人的医疗保健会面和新冠肺炎诊断信息的“新冠肺炎队列”(n=~341万 )。采用倾向得分匹配法将PLWH与非PLWH的对照组进行配对。为了区分免疫水平在影响疫苗有效性中的作用，我们将进行亚组分析，比较病毒控制和免疫抑制的PLWH与非PLWH的结果。将使用条件Logistic回归和广义线性模型，通过调整潜在的混杂因素来分析艾滋病毒状况和保护持久性之间的关系。这项研究被南卡罗来纳大学的机构审查委员会(Pro00117583)批准为非人类主题研究。这项研究的结果将发表在同行评议的期刊上，并在国内和国际会议上以及通过社交媒体传播。
Despite the effectiveness of COVID-19 vaccines in preventing severe COVID-19 outcomes, a small percentage of fully vaccinated persons will develop symptomatic or asymptomatic infections with SARS-CoV-2, which is referred to as ‘breakthrough COVID-19’. People living with HIV (PLWH) appear to have an elevated risk of severe COVID-19 outcomes, yet the effectiveness of the COVID-19 vaccine in this population remains unclear due to the limited research efforts in this population in the real world. This study aims to characterise and compare the breakthrough COVID-19 (eg, prevalence and disease severity) between PLWH and non-PLWH and then examine whether HIV markers play a role in COVID-19 vaccine effectiveness within the PLWH population. This cohort study will merge electronic health records data from multiple data sources in South Carolina (SC), including the ‘HIV Cohort’ (n=12 203) identified from the statewide Enhanced HIV/AIDS Reporting System, ‘Vaccine Cohort’ from the Statewide Immunisation Online Network which provides patient-level immunisation records (n=~1.71 million), and ‘COVID-19 Cohort’ which includes healthcare encounters and COVID-19 diagnosis information for all individuals who were tested for COVID-19 (n=~3.41 million). The PLWH will be matched with a comparison group of non-PLWH by the propensity score matching method. To distinguish the role of immunity level in affecting the vaccine effectiveness, we will conduct subgroup analyses to compare the outcome of virally controlled and immunosuppressed PLWH with non-PLWH. Conditional logistic regression and generalised linear models will be employed to analyse the relationship between HIV status and protection durability by adjusting for potential confounders. The study was approved by the Institutional Review Board at the University of South Carolina (Pro00117583) as a Non-Human Subject study. The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences and through social media.
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影响因子：
33.9
作者：
Tenforde, Mark W.;Olson, Samantha M.;Self, Wesley H.;Talbot, H. Keipp;Lindsell, Christopher J.;Steingrub, Jay S.;Shapiro, Nathan, I;Ginde, Adit A.;Douin, David J.;Prekker, Matthew E.;Brown, Samuel M.;Peltan, Ithan D.;Gong, Michelle N.;Mohamed, Amira;Khan, Akram;Aline, Matthew C.;Files, D. Clark;Gibbs, Kevin W.;Stubblefield, William B.;Casey, Jonathan D.;Rice, Todd W.;Grijalva, Carlos G.;Hager, David N.;Shehu, Arber;Qadir, Nida;Chang, Steven Y.;Wilson, Jennifer G.;Gaglani, Manjusha;Murthy, Kempapura;Calhoun, Nicole;Monto, Arnold S.;Martin, Emily T.;Malani, Anurag;Zimmerman, Richard K.;Silveira, Fernanda P.;Middleton, Donald B.;Zhu, Yuwei;Wyatt, Dayna;Stephenson, Meagan;Baughman, Adrienne;Womack, Kelsey N.;Hart, Kimberly W.;Kobayashi, Miwako;Verani, Jennifer R.;Patel, Manish M.
通讯作者：
Patel, Manish M.
BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
影响因子：
15.1
作者：
Feng Y;Zhang Y;He Z;Huang H;Tian X;Wang G;Chen D;Ren Y;Jia L;Wang W;Wu J;Shao L;Zhang W;Tang H;Wan Y
通讯作者：
Wan Y
影响因子：
15.9
作者：
Riou, Catherine;du Bruyn, Elsa;Wilkinson, Robert J.
通讯作者：
Wilkinson, Robert J.
影响因子：
3.8
作者：
Olatosi, Bankole A.;Probst, Janice C.;Duffus, Wayne A.
通讯作者：
Duffus, Wayne A.