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临床试验/NCT05089565
NCT05089565已完成不适用

Assessment of the Immune Response to SARS-CoV-2/COVID-19 Vaccination in Patients With Sarcoidosis

Northwestern University1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Humeral immune response

研究概览

简要总结

People with sarcoidosis, particularly those with significant lung and/or cardiac involvement, who become infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) are likely at increased risk of complications or death from COVID-19. While SARS-CoV-2 vaccines are highly efficacious in preventing COVID-19 in the general population, whether vaccination provides similar protection in people with sarcoidosis is unknown. The investigators hypothesize that people with sarcoidosis develop less robust antibody and cell-mediated immune responses to SARS-CoV-2 vaccination than healthy individuals, both as a consequence of the disease itself and due to treatment with immunosuppressive medications. This hypothesis will be examined by determining levels of anti-SARS-CoV-2 spike protein immunoglobulin G (IgG) antibody (Specific Aim 1) and measuring SARS-CoV-2-specific activation of peripheral blood T cells (Specific Aim 2) following SARS-CoV-2 vaccination in individuals with sarcoidosis treated and not treated with immunosuppressive medications, in comparison to age- and sex-matched healthy controls. For Specific Aim 1, a second-generation anti-SARS-CoV-2 spike IgG assay calibrated against an independent virus neutralization assay will be utilized. The results of this investigation will address a critical gap in the understanding of vaccine responses in people with sarcoidosis. In addition, the study will contribute knowledge needed to inform clinicians' recommendations to sarcoidosis patients regarding risk of infection after SARS-CoV-2 vaccination, and will help lay the basis for future trials to evaluate the possible benefit of vaccine boosters in individuals with poor immune responses to initial vaccination.

详细描述

Introduction, Hypothesis and Specific Aims

People with sarcoidosis, particularly those with significant lung and/or cardiac involvement, who become infected with SARS-CoV-2 are likely at increased risk of complications or death from COVID-19. While SARS-CoV-2 vaccines are highly efficacious in preventing COVID-19 in the general population, whether vaccination provides similar protection in people with sarcoidosis is unknown. The investigators hypothesize that people with sarcoidosis develop less robust antibody and cluster of differentiation 4 (CD4)+ T cell-mediated immune responses to SARS-CoV-2 vaccination than healthy individuals, both as a consequence of the disease itself and as a result of treatment with immunosuppressive medications.

Specific Aim 1. Determine blood anti-SARS-CoV-2 spike protein IgG antibody levels following SARS-CoV-2 vaccination in individuals with sarcoidosis treated and not treated with immunosuppressive medications, in comparison to age- and sex-matched healthy controls.

Specific Aim 2. Determine levels of SARS-CoV-2-specific activation of peripheral blood CD4+ T cells following SARS-CoV-2 vaccination in individuals with sarcoidosis treated and not treated with immunosuppressive medications, in comparison to age- and sex-matched healthy controls.

The results of this investigation will address a critical gap in the understanding of vaccine responses in people with sarcoidosis. In addition, the study will contribute knowledge needed to inform clinicians' recommendations to sarcoidosis patients regarding risk of infection after SARS-CoV-2 vaccination, and will help lay the basis for future trials to evaluate the possible benefit of vaccine boosters in individuals with poor immune responses to initial vaccination.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Humeral immune response

时间窗: 2 weeks to 1 year following primary vaccination, or primary + booster vaccination

Anti-spike IgG level

Cell-mediated immune response

时间窗: 2 weeks to 1 year following primary vaccination, or primary + booster vaccination

Level of interferon-gamma release by peripheral blood T cells in response to SARS-CoV-2 peptide stimulation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Sporn, MD

Professor of Medicine

Northwestern University

研究点 (1)

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