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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vaccine Adverse Reaction, Seroconversion

Intervention / Treatment
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* Biological: SARS-Cov-2 neutralizing antibody titer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health-care workers<br>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<br>* Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine<br>|

What is the study measuring?
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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 |