The COVID-19 vaccine efficacy among people living with and without HIV: a real-world data approach

COVID-19 疫苗在艾滋病毒感染者和未感染者中的功效：真实世界数据方法

• 批准号: 10640994
• 负责人: Xueying Yang
• 金额: $ 14.32万
• 依托单位: UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-10 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10640994
• 关键词: 2019-nCoV; Achievement; Acquired Immunodeficiency Syndrome; Affect; Antibodies; Authorization documentation; Big Data; CD4 Lymphocyte Count; CD4 Positive T Lymphocytes; COVID-19; COVID-19 diagnosis; COVID-19 outbreak; COVID-19 pandemic; COVID-19 risk; COVID-19 vaccination; COVID-19 vaccine; Case Series; Case Study; Cessation of life; Clinical; Clinical Management; Data; Data Analytics; Data Set; Databases; Decision Making; Diagnosis; Disease; Dose; Effectiveness; Electronic Health Record; Ensure; Female; Funding; Future; Guidelines; HIV; Healthcare; Hospitalization; Immune response; Immunization; Immunocompromised Host; Immunosuppression; Incidence; Individual; Infection; Measures; Medical; Monitor; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Patients; Persons; Phase; Population; Predisposition; Prevalence; Preventive measure; Randomized, Controlled Trials; Recommendation; Records; Reporting; Research; Risk; SARS-CoV-2 B.1.1.529; SARS-CoV-2 antibody; SARS-CoV-2 infection; Sample Size; Severity of illness; Social Distance; Societies; South Carolina; T-Cell Depletion; Time; United States National Institutes of Health; Update; Vaccination; Vaccinee; Vaccines; Viral; Viral Load result; Vulnerable Populations; acquired immunodeficiency; antiretroviral therapy; authority; booster vaccine; breakthrough infection; clinical practice; cohort; comorbidity; comparison group; coronavirus disease; efficacy trial; experience; health care service utilization; health equity promotion; high risk; human old age (65+); innovation; mortality; multiple data sources; neutralizing antibody; post-COVID-19; prevent; protective effect; response; surveillance data; symptomatic COVID-19; vaccine development; vaccine distribution; vaccine efficacy

Project Summary/Abstract Effective and durable COVID-19 vaccines hold the potential to dramatically alter the COVID-19 pandemic. Remarkable achievement of COVID-19 vaccine development was observed in large, randomized-controlled trials, where several vaccines were found to be safe and efficacious in preventing symptomatic COVID-19. Despite the high level of vaccine efficacy, a small percentage of fully vaccinated persons (i.e., received all recommended doses of an FDA-authorized COVID-19 vaccine) will develop symptomatic or asymptomatic infections of SARS-CoV-2, which is referred to as COVID-19 vaccine breakthrough infections (hereafter as “breakthrough infections”). Immunocompromised individuals, such as people living with HIV (PLWH), appear to be at an elevated risk of COVID-related illness, hospitalization, and death. Thus, ensuring the effectiveness of COVID-19 vaccine in PLWH is pressing. However, the efficacy of COVID-19 vaccine among PLWH remains unclear because PLWH were not representatively included in the vaccine efficacy trials and did not account for a large proportion in the existing efforts to investigate vaccine efficacy among immunocompromised population in the real-world. Understanding COVID-19 vaccine efficacy in real-world settings is critical to helping disease monitoring and inform future booster vaccine distribution. With NIH support (R01AI127203) since 2017, we have been utilizing a Big Data approach to examine the treatment gaps among 12,203 PLWH who were diagnosed with HIV during 2005-2020 (‘HIV Cohort’) in South Carolina (SC). Also supported by NIH (R01AI127203-04S1), our team have established a South Carolina COVID-19 cohort (S3C) since 06/2020 by integrating patients’ electronic health records (EHR) with one-year pre-COVID healthcare utilization data. In this exploratory study, we will retrieve the patient-level immunization records from the South Carolina Statewide Immunization Online Network (SIMON) and merge this database with ‘HIV Cohort’ database to identify vaccinated PLWH and a comparison group of non-PLWH via propensity score matching. The S3C cohort data, which includes healthcare encounters and COVID-19 diagnosis information, will be merged with HIV Cohort and SIMON datasets to define the breakthrough infections. With the integration of multiple data sources and advanced data analytics, the current exploratory study first aims to characterize and compare the breakthrough infections (e.g., prevalence and disease severity) between PLWH and non-PLWH and then examine whether HIV markers and HIV treatment play a role in COVID-19 vaccine efficacy within the PLWH population while adjusting for key confounders (e.g., prior COVID-19 diagnosis, comorbid conditions, local COVID-19 incidence). The proposed research is innovative and significant because understanding the COVID- 19 vaccine efficacy among PLWH and non-PLWH is essential to support informed vaccination decision-making in clinical practice. Characterizing PLWH at higher risk of breakthrough infections (low CD4 counts, unsuppressed viral load) may help to develop guidance to augment their protection against risk of COVID-19.

项目摘要/摘要 有效耐用的Covid-19疫苗具有显着改变COVID-19大流行的潜力。 Covid-19疫苗开发的显着成就 被观察到 大，随机控制 试验，发现几种疫苗在预防有症状的Covid-19中是安全有效的。 尽管疫苗效率很高，但完全接种疫苗的人（即收到了全部疫苗接种的人） 推荐的FDA授权的Covid-19疫苗将出现有症状或无症状的剂量 SARS-COV-2的感染，被称为Covid-19疫苗突破感染（以下称为 “突破性感染”）。免疫功能低下的人，例如患有艾滋病毒（PLWH）的人，出现 患有相关疾病，住院和死亡的风险较高。那，确保有效性 PLWH中的Covid-19疫苗的压力。但是，PLWH中的Covid-19疫苗的效率仍然存在 不清楚，因为PLWH未代表在疫苗效率试验中，也没有考虑 现有的研究疫苗效率的现有努力很大一部分 现实世界中的人口。了解现实世界中的Covid-19疫苗效率对 帮助疾病监测并告知未来的增强疫苗分布。 NIH支持（R01AI127203） 自2017年以来，我们一直在使用大数据方法来检查12,203 PLWH之间的治疗差距 在2005 - 2020年在南卡罗来纳州（SC）被诊断出患有艾滋病毒的人。也支持 NIH（R01AI127203-04S1），我们的团队自06/2020以来就建立了南卡罗来纳州Covid-19 Cohort（S3C） 通过将患者的电子健康记录（EHR）与一年的预循环前医疗保健利用数据相结合。 在这项探索性研究中，我们将从南卡罗来纳州检索患者水平的免疫记录 州范围内的免疫在线网络（SIMON），并将此数据库与“ HIV队列”数据库合并到 通过倾向分数匹配确定接种的PLWH和非PLWH的比较组。 S3C 包括医疗保健遭遇和COVID-19诊断信息在内的队列数据将与 HIV队列和Simon数据集以定义突破性感染。随着多个数据的集成 来源和高级数据分析，当前的探索性研究首先旨在表征和比较 PLWH和非PLWH之间的突破性感染（例如患病率和疾病严重程度），然后 检查HIV标记和HIV治疗是否在PLWH中的Covid-19疫苗效率中起作用 在调整关键混杂因素的同时（例如，先前的COVID-19诊断，合并症，本地 COVID-19事件）。拟议的研究具有创新性和意义 19 PLWH和非PLWH中的疫苗效率对于支持知情疫苗决策至关重要 在临床实践中。表征PLWH以较高的突破感染风险（低CD4计数， 未经抑制的病毒负荷）可能有助于开发指导以增加其防止Covid-19的风险的保护。

项目成果

COVID-19 vaccine effectiveness among people living with and without HIV in South Carolina, USA: protocol of a population-based cohort study.

• DOI: 10.1136/bmjopen-2022-067095
• 发表时间: 2022-08-23
• 期刊: BMJ OPEN
• 影响因子: 2.9
• 作者: Yang Xueying;Zhang, Jiajia;Olatosi, Bankole;Weissman, Sharon;Li, Xiaoming
• 通讯作者: Li, Xiaoming

COVID-19 breakthrough infections among people living with and without HIV: A statewide cohort analysis.

HIV 感染者和未感染者中的 COVID-19 突破性感染：全州范围的队列分析。

• DOI: 10.1016/j.ijid.2023.11.029
• 发表时间: 2024
• 期刊: International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
• 作者: Yang,Xueying;Zhang,Jiajia;Liu,Ziang;Chen,Shujie;Olatosi,Bankole;Poland,GregoryA;Weissman,Sharon;Li,Xiaoming
• 通讯作者: Li,Xiaoming