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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-11

Study Completion Date

2021-12-22

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.

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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.

Conditions

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Vaccine Adverse Reaction Seroconversion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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 Blood samples will be withdrawn from them to investigate the immune response to the given vaccine

Group Type EXPERIMENTAL

SARS-Cov-2 neutralizing antibody titer

Intervention Type BIOLOGICAL

Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine

Interventions

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SARS-Cov-2 neutralizing antibody titer

Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes