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

Vaccine Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756271
• Other study ID #: 6738-14-2-21
• Status: Completed
• Phase: Phase 3
• Start date: February 11, 2021
• Est. completion date: December 22, 2021

Study information

• Verified date: February 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 22, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Seroconversion
• Vaccine Adverse Reaction

Intervention

Biological:
• SARS-Cov-2 neutralizing antibody titer
Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine

Locations

Country	Name	City	State
Egypt	Zagazig University Faculty of Medicine	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse reactions	Incidence of adverse reactions after each dose of the vaccine	7 days after each dose
Primary	Seroconversion rate of neutralizing antibody	Neutralizing antibody assay will be performed after each dose of the vaccine	84 days after each dose