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: 10547230
• 负责人: Xueying Yang
• 金额: $ 25.51万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547230
• 关键词: 2019-nCoV; Achievement; Acquired Immunodeficiency Syndrome; Affect; Antibodies; 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; Centers for Disease Control and Prevention (U.S.); 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; Lead; Measures; Medical; Monitor; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Patients; Persons; Phase; Play; Population; Predisposition; Prevalence; Preventive measure; Randomized Controlled Trials; Records; Reporting; Research; Risk; Role; 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; Variant; Viral; Viral Load result; Vulnerable Populations; acquired immunodeficiency; antiretroviral therapy; 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.

项目概要/摘要 有效且持久的 COVID-19 疫苗有可能显着改变 COVID-19 大流行。 COVID-19疫苗研发取得显著成就 被观察到 在大型、随机对照 试验发现，多种疫苗在预防有症状的 COVID-19 方面是安全有效的。 尽管疫苗功效水平很高，但仍有一小部分人完全接种了疫苗（即接受了所有疫苗接种）。 FDA 授权的 COVID-19 疫苗的推荐剂量）将出现有症状或无症状 SARS-CoV-2 感染，称为 COVID-19 疫苗突破性感染（以下简称 “突破性感染”）出现。 与新冠病毒相关的疾病、住院和死亡的风险较高，从而确保有效性。 然而，COVID-19 疫苗在 PLWH 中的疗效仍然存在。 不清楚，因为 PLWH 没有代表性地纳入疫苗功效试验，也没有考虑到 现有工作中很大一部分是研究免疫功能低下者的疫苗功效 了解现实世界中的 COVID-19 疫苗功效对于了解现实世界中的人群至关重要。 在 NIH 的支持下帮助疾病监测并为未来的加强疫苗分发提供信息 (R01AI127203)。 自 2017 年以来，我们一直利用大数据方法来检查 12,203 名感染者的治疗差距 2005 年至 2020 年期间在南卡罗来纳州 (SC) 被诊断出感染艾滋病毒的人（“艾滋病毒队列”）也得到了支持。 NIH (R01AI127203-04S1)，我们的团队自 2020 年 6 月起建立了南卡罗来纳州 COVID-19 队列 (S3C) 通过将患者的电子健康记录 (EHR) 与新冠疫情前一年的医疗保健利用数据相整合。 在这项探索性研究中，我们将检索来自南卡罗来纳州的患者级免疫记录 全州免疫在线网络 (SIMON) 并将该数据库与“HIV 队列”数据库合并以 通过倾向评分匹配识别肺炎感染者和非感染者的对照组。 队列数据，包括医疗保健经历和 COVID-19 诊断信息，将与 HIV 队列和 SIMON 数据集通过整合多个数据来定义突破性感染。 来源和高级数据分析，当前的探索性研究首先旨在描述和比较 感染者和非感染者之间的突破性感染（例如患病率和疾病严重程度），然后 检查 HIV 标记和 HIV 治疗是否对 PLWH 内的 COVID-19 疫苗功效发挥作用 人口，同时调整关键混杂因素（例如，先前的 COVID-19 诊断、合并症、当地 拟议的研究具有创新性和重要意义，因为了解了 COVID-19 的发病率。 19 感染者和非感染者的疫苗功效对于支持明智的疫苗接种决策至关重要 在临床实践中表征 PLWH 具有较高的突破性感染风险（CD4 计数低、 未抑制的病毒载量）可能有助于制定指南，以增强他们对 COVID-19 风险的保护。