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

Zagazig University

Status and phase: Completed; Phase 3

Conditions: Vaccine Adverse Reaction; Seroconversion

Treatments: Biological: SARS-Cov-2 neutralizing antibody titer

Study type: Interventional

Funder types: Other

Identifiers

NCT04756271

6738-14-2-21

Details and patient eligibility

About

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 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.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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246 participants in 1 patient group

Health-care workers

Experimental group

Description:

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

Treatment:

Biological: SARS-Cov-2 neutralizing antibody titer