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临床试验/NCT05338736
NCT05338736已完成不适用

Differences in Humoral and Cellular Immunity in First-cycle Vaccinated Patients Infected by SARS-COV-2: an Observational Study

University Magna Graecia1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins

研究概览

简要总结

Infection by the recent Coronavirus (SARS-CoV-2) has generated at a pandemic level a new pathology, called COVID-19, characterized by "flu-like" symptoms up to severe acute respiratory failure. The pathogenesis of the disease involves both humoral and cellular immunological responses; cell-mediated immunity is the first and most effective immune response to viral infection. To date, despite the extensive scientific research aimed at curing COVID-19, there are few effective means to tackle SARS-CoV-2 infection and reduce its disease progression. Among these, a first complete anti-SARS-CoV-2 vaccination course has been shown to significantly reduce the development of the disease towards the more severe forms requiring hospital and intensive care. On the other hand, over time the antibody response induced by vaccines against SARS-CoV-2 decreases, so much so as to indicate the need for a third booster dose. This translates into the fact that some patients who have undergone a complete first vaccination course, with third dose booster indications, develop severe critical disease, with the need for hospitalization. On the other hand, other patients with the same vaccination status do not develop the disease, although they are also positive for SARS-CoV-2. The investigators therefore hypothesized that the humoral and cell-mediated response among groups of patients may be radically different. For these reasons, the investigators designed this observational pilot study in order to analyze humoral and cell-mediated responses in SARS-CoV-2 positive first complete vaccination patients.

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

  • Patients with a complete first-cycle vaccination against SARS-CoV-2 performed 4 to 7 months before.

排除标准

  • Presence of malignancy under chemotherapy
  • Patient with previous transplantation
  • Patient receiving immuno-modulatory or immunosuppressive drugs
  • Patient receiving corticosteroid therapy since more than 10 days
  • Pregnancy
  • Consent withdrawal

结局指标

主要结局

Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins

时间窗: At day 0

After obtaining plasma of included patients, the plasma will be processed with a dedicated kit to measure the concentration of Immunoglobulin G and M. Differences between patients' cohorts will be assessed

Differences between populations with respect to cellular immunity

时间窗: At day 0

Mononuclear immunity cells will be analyzed with a dedicated ELISpot kit to assess their response to SARS-CoV-2

次要结局

未报告次要终点

研究者

发起方
University Magna Graecia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Longhini

Director of the Intensive Care and Anesthesia Department

University Magna Graecia

研究点 (1)

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