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

February 7, 2022 updated by: Noha M Hammad, MD, Zagazig University

Safety and Immunogenicity of Oxford AstraZeneca Vaccine in Zagazig University Hospital Health-care Workers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Biological: SARS-Cov-2 neutralizing antibody titer
Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Noha M Hammad, MD, Faculty of Medicine, Zagazig University , Zagazig, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2021

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

December 22, 2021

Study Registration Dates

First Submitted

February 13, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6738-14-2-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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