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.

项目摘要/摘要 有效和耐用的新冠肺炎疫苗有可能极大地改变新冠肺炎大流行。 新冠肺炎疫苗研发成果显著 被观察到 在大规模、随机控制的 试验发现，几种疫苗在预防有症状的新冠肺炎方面安全有效。 尽管疫苗效力水平很高，但一小部分完全接种疫苗的人(即接种了所有疫苗) 推荐剂量的FDA授权的新冠肺炎疫苗)会出现症状或无症状 SARS-CoV-2的感染，简称新冠肺炎疫苗突破性感染(以下简称 “突破性感染”)。免疫功能受损的人，如艾滋病毒携带者(PLWH)，出现了 与COVID相关的疾病、住院和死亡的风险增加。因此，确保了有效性 新冠肺炎疫苗在PLWH的应用迫在眉睫。然而，新冠肺炎疫苗在PLWH中的疗效仍然存在 不清楚，因为PLWH没有被代表性地包括在疫苗疗效试验中，也没有考虑到 在现有的努力中，有很大一部分是在免疫缺陷人群中调查疫苗效力的 真实世界中的人口。了解新冠肺炎疫苗在现实世界中的效力对于 帮助监测疾病，并为未来加强疫苗的分发提供信息。具有NIH支持(R01AI127203) 自2017年以来，我们一直在利用大数据方法来检查12,203名PLWH的治疗差距 2005-2020年期间在南卡罗来纳州(SC)被诊断为艾滋病毒携带者(“HIV Cohort”)。还支持 NIH(R01AI127203-04S1)，我们的团队从2020年6月开始建立了南卡罗来纳州新冠肺炎队列(S3C 通过将患者的电子健康记录(EHR)与COVID前一年的医疗保健利用数据进行整合。 在这项探索性研究中，我们将检索南卡罗来纳州患者级别的免疫记录 全州免疫在线网络(Simon)，并将该数据库与‘HIV Cohort’数据库合并，以 通过倾向性评分匹配，识别接种PLWH的人群和未接种PLWH的对照组。S3C 队列数据，包括医疗保健就诊和新冠肺炎诊断信息，将与 HIV Cohort和Simon数据集来定义突破性感染。通过集成多个数据 来源和高级数据分析，目前的探索性研究首先旨在描述和比较 PLWH和非PLWH之间的突破性感染(例如，流行率和疾病严重性)，然后 检查艾滋病病毒标志物和艾滋病病毒治疗是否在公共卫生医院内的新冠肺炎疫苗疗效中发挥作用 调整关键混杂因素(例如，先前的新冠肺炎诊断、并存疾病、当地情况)的同时进行总体调整 新冠肺炎发病率)。这项拟议的研究具有创新性和重要意义，因为了解COVID- 19公共卫生部门和非公共卫生部门之间的疫苗效力对于支持知情的疫苗接种决策至关重要。 在临床实践中。PLWH具有更高的突破性感染风险(低CD4计数， 未抑制的病毒载量)可能有助于制定指南，以加强他们对新冠肺炎风险的保护。