NCT04756271

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaccine Adverse Reaction
• Seroconversion

Interventions

Type	Name	Description
BIOLOGICAL	SARS-Cov-2 neutralizing antibody titer	Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine

Timeline

• Start date: 2021-02-11
• Primary completion: 2021-12-20
• Completion: 2021-12-22
• First posted: 2021-02-16
• Last updated: 2022-02-09

Locations

1 site across 1 country: Egypt