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临床试验/NCT05049187
NCT05049187已完成不适用

Characterization and Durability of COVID-19 Vaccine Induced Immune Responses in Healthcare/Frontline Workers

Tuberculosis Research Centre, India1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2021年5月7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
132
试验地点
1
主要终点
Ratio of immune biomarker production

研究概览

简要总结

Rationale: Early in the covid-19 pandemic, it was unclear whether and how individuals and populations would develop protective and enduring immunity against SARS-CoV-2, either after infection or vaccination. It is still not clear what role might immune cellular responses play in the development of immunity to SARS-CoV-2 infection and what are the implications for vaccines? As T cells recognise and respond to viral antigens they produce many protective reactions and effector molecules. One such molecule is the cytokine interferon γ, secreted by CD4+ and CD8+ T cells and their memory cells. This can be measured means of documenting specific T cell responses to viral antigens. Published studies offered a strong evidence that T cell immune responses are sustained, even in the face of declining or undetectable antibodies, implying that some immunity persists. The evidence from new studies, interim results from phase III vaccine trials, and previous data from phase I and phase II trials support the notion that memory T cell responses to the vaccines, along with B cell antibody responses, should provide good and possibly enduring immunity to SARS-Cov-2. We propose to describe and characterize the humoral, innate and long-term adaptive immune responses and the neutralization potential generated by COVID-19 vaccination (Covaxin, Covishield) among healthcare and frontline workers.

详细描述

Study objectives i. To estimate the neutralizing antibodies titre against SARS CoV-2 by vaccine type.

ii. To estimate the proportion of vaccine recipients developing effective antibody response for SARS-CoV-2 specific IgG, IgM, and total IgE and IgA antibodies pre- and post-COVID-19 vaccination on day zero, day 28, month 2, 3, 6, 12, 18 and 24 by vaccine type.

iii. To identify and characterize the immune biomarkers for long term innate and adaptive immune response by vaccine type.

iv. To estimate the ratio of immune biomarker levels between pre- and post- COVID-19 vaccination at days 28, month 2, 3, 6, 12, 18 and 24 by vaccine type

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-60 years
  • Should have been vaccinated with either Covaxin or Covishield
  • Willing to provide written informed consent

排除标准

  • Participants will be ineligible if they are not vaccinated for either Covaxin or Covishield vaccine
  • Not willing to provide written informed consent

结局指标

主要结局

Ratio of immune biomarker production

时间窗: 2 years

The ratio of immune biomarkers production between pre and post COVID-19 vaccination

Antibody titers

时间窗: 2 years

IgM and IgG SARS-Cov2 specific antibody titres and IgA and IgE (total)

次要结局

未报告次要终点

研究者

发起方
Tuberculosis Research Centre, India
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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