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临床试验/NCT04706143
NCT04706143Unknown不适用

T Cell, Antibody and Cytokine Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians

Assiut University0 个研究点目标入组 100 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
measure the cytokine response to different vaccines

研究概览

简要总结

The recent Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and development of safe, effective vaccines is mandatory to return back to pre pandemic life. Many vaccines have been developed and requested by the authorities after the emergency license issued. The main mechanism of protection is through humoral and cell-mediated immune responses that might reduce the potential for disease development or severity. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection. Preliminary data are now available indicating safty and effecacy of different vaccines . The vaccines were tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. The aim of this work is to evaluate the immune responses in adults, aged 25-65 years, up to 8 weeks after vaccination with a single and double doses live inactivated (Sinopharm), mRNA (Pfizer/ Biontech) and viral vector (Oxford/AZ- ChAdOx1 nCoV-19) vaccines. The Th1- response ( interferon-γ and tumor necrosis factor-α cytokine secretion by CD4+ T cells) and antibody production predominantly of IgG1 and IgG3 subclasses as well as CD8+ T cells mono, polyfunctional and cytotoxic phenotypes, will be also measured.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy adults receiving COVID-19 vaccines

排除标准

  • any contraindication of each COVID-19 vaccine as listed by WHO

结局指标

主要结局

measure the cytokine response to different vaccines

时间窗: 8 weeks

level of IL-1, IL-2, TNF-alpha, IFN- gamma, My/dl

measure immune cell activation induced by the vaccine

时间窗: 8 weeks

estimate number of lymphocytes, T cells, Natural killer cells and B cells

measure antibody response to vaccines

时间窗: 8 weeks

evaluation of IgG and IgM levels, mg/dl

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

Aliae AR Mohamed Hussein

Professor of Pulmonology

Assiut University

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