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Trial record 6 of 27 for:    mRNA | COVID-19

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04706143
Recruitment Status : Not yet recruiting
First Posted : January 12, 2021
Last Update Posted : January 14, 2021
Information provided by (Responsible Party):
Aliae AR Mohamed Hussein, Assiut University

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.

Condition or disease Intervention/treatment
COVID-19 Vaccines Biological: COVID-19 Vaccines

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: T Cell, Antibody and Cytokine Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians
Estimated Study Start Date : January 15, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Group/Cohort Intervention/treatment
Vaccined group by live attenuated or viral vector or mRNA vaccine
Adults between 25-65 years old
Biological: COVID-19 Vaccines
different available vaccines: live inactivated, mRNA and viral vector vaccines

Primary Outcome Measures :
  1. measure immune cell activation induced by the vaccine [ Time Frame: 8 weeks ]
    estimate number of lymphocytes, T cells, Natural killer cells and B cells

  2. measure antibody response to vaccines [ Time Frame: 8 weeks ]
    evaluation of IgG and IgM levels, mg/dl

  3. measure the cytokine response to different vaccines [ Time Frame: 8 weeks ]
    level of IL-1, IL-2, TNF-alpha, IFN- gamma, My/dl

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy adults aged from 25-65 years old non immune-compromised or immune suppressed receiving COVID-19 vaccines

Inclusion Criteria:

  • healthy adults receiving COVID-19 vaccines

Exclusion Criteria:

  • any contraindication of each COVID-19 vaccine as listed by WHO
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Responsible Party: Aliae AR Mohamed Hussein, Professor of Pulmonology, Assiut University Identifier: NCT04706143    
Other Study ID Numbers: AssiutU21
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aliae AR Mohamed Hussein, Assiut University:
T cell responses
Cytokine responses
Antibody responses