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

NCT04706143 | Unknown

• 1 other identifier: AssiutU21
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19 Vaccines

Keywords

COVID-19; Safety; Efficacy; T cell responses; Cytokine responses; Antibody responses

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Vaccined group by live attenuated or viral vector or mRNA vaccine

Adults between 25-65 years old

Biological: COVID-19 Vaccines

Interventions

COVID-19 Vaccines BIOLOGICAL

different available vaccines: live inactivated, mRNA and viral vector vaccines

Vaccined group by live attenuated or viral vector or mRNA vaccine

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• healthy adults receiving COVID-19 vaccines

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pulmonology

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 12, 2021
• Study Start: January 15, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share