T Cell, Antibody and Cytokine Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians
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
- 是
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
Aliae AR Mohamed Hussein
Professor of Pulmonology
Assiut University
