Safety and Immunogenicity of Oxford AstraZeneca Vaccine in Zagazig University Hospital Health-care Workers
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Seroconversion rate of neutralizing antibody
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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 Blood samples will be withdrawn from them to investigate the immune response to the given vaccine
Intervention: SARS-Cov-2 neutralizing antibody titer (Biological)
Outcomes
Primary Outcomes
Seroconversion rate of neutralizing antibody
Time Frame: 84 days after each dose
Neutralizing antibody assay will be performed after each dose of the vaccine
Incidence of adverse reactions
Time Frame: 7 days after each dose
Incidence of adverse reactions after each dose of the vaccine
Secondary Outcomes
No secondary outcomes reported
Investigators
Noha M Hammad, MD
Principal investigator
Zagazig University