Immunologic Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19 Vaccines

Intervention / Treatment
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* Biological: COVID-19 Vaccines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adults receiving COVID-19 vaccines Exclusion Criteria: any contraindication of each COVID-19 vaccine as listed by WHO

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccined group by live attenuated or viral vector or mRNA vaccine<br>Adults between 25-65 years old | Biological: COVID-19 Vaccines<br>* different available vaccines: live inactivated, mRNA and viral vector vaccines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure immune cell activation induced by the vaccine | estimate number of lymphocytes, T cells, Natural killer cells and B cells | 8 weeks | 
| measure antibody response to vaccines | evaluation of IgG and IgM levels, mg/dl | 8 weeks | 
| measure the cytokine response to different vaccines | level of IL-1, IL-2, TNF-alpha, IFN- gamma, My/dl | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Safety, Efficacy, T cell responses, Cytokine responses, Antibody responses