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

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: Vaccine Adverse Reaction; Seroconversion
• Intervention / Treatment: Biological: SARS-Cov-2 neutralizing antibody titer

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

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

Study record dates

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: Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Blocking
• 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