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Clinical Trials/NCT04706143
NCT04706143
Unknown
Not Applicable

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

Assiut University0 sites100 target enrollmentJanuary 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 Vaccines
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
measure the cytokine response to different vaccines
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2021
End Date
August 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aliae AR Mohamed Hussein

Professor of Pulmonology

Assiut University

Eligibility Criteria

Inclusion Criteria

  • healthy adults receiving COVID-19 vaccines

Exclusion Criteria

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

Outcomes

Primary Outcomes

measure the cytokine response to different vaccines

Time Frame: 8 weeks

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

measure immune cell activation induced by the vaccine

Time Frame: 8 weeks

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

measure antibody response to vaccines

Time Frame: 8 weeks

evaluation of IgG and IgM levels, mg/dl

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