Safety and Immunogenicity of Oxford AstraZeneca Vaccine Against COVID-19 Infection

Overview

After SARS-COV-2 inactivated vaccine authorization for use in different countries including Egypt, investigating its immunogenicity, safety, and efficacy in preventing COVID-19 infection is highly needed. In Egypt, immunization of HCWs in isolation hospitals by SARS-COV-2 inactivated vaccine is now a national priority. Moreover, data and reports regarding the application of vaccine are still limited and deficient.

Full Title of Study: “Safety and Immunogenicity of Oxford AstraZeneca Vaccine in Zagazig University Hospital Health-care Workers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 20, 2021

Detailed Description

This study will be conducted at Zagazig University hospital. Laboratory work will be implemented at Immunology Research Laboratory at Microbiology and Immunology Department, Faculty of Medicine, Zagazig University. A representative sample will be drawn from healthcare workers (HCWs) at Zagazig University Hospital. Assessment of inclusion and exclusion criteria by history taking. Blood samples will be drawn from HCWs by direct venipuncture before the start of immunization and 14 days after immunization. The incidence of any adverse reactions after each immunization will be recorded. SARS-CoV-2 neutralizing antibodies will be detected by enzyme-linked immunosorbent assay.

Interventions

  • Biological: SARS-Cov-2 neutralizing antibody titer
    • Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine

Arms, Groups and Cohorts

  • Experimental: Health-care workers
    • Healthy health-care workers at Zagazig University Hospital who opt by their free well to administer 2 doses of SARS-Cov-2 inactivated vaccine at 0 and 21 days. Blood samples will be withdrawn from them to investigate the immune response to the given vaccine

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of adverse reactions
    • Time Frame: 7 days after each dose
    • Incidence of adverse reactions after each dose of the vaccine
  • Seroconversion rate of neutralizing antibody
    • Time Frame: 84 days after each dose
    • Neutralizing antibody assay will be performed after each dose of the vaccine

Participating in This Clinical Trial

Inclusion Criteria

-Healthy healthcare workers Exclusion Criteria:

  • Healthy healthcare workers' refusal. – Pregnancy and lactation. – Confirmed acute cases of SARS-CoV-2 Infection – Having a history of SARS-CoV-2 infection in the past 3 months. – Fever (body temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination. – History of allergy to any vaccines – Previous vaccination within the last 30 days

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Zagazig University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Noha M Hammad, MD, Principal investigator – Zagazig University
  • Overall Official(s)
    • Noha M Hammad, MD, Principal Investigator, Faculty of Medicine, Zagazig University , Zagazig, Egypt

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