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

Phase 3

Completed

• Conditions: Vaccine Adverse Reaction; Seroconversion
• Interventions: Biological: SARS-Cov-2 neutralizing antibody titer

• Registration Number: NCT04756271
• Lead Sponsor: Zagazig University

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 Timeline

• Study Start: 2021-02-11
• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-16
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health-care workers	SARS-Cov-2 neutralizing antibody titer	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

Primary Outcome Measures

Name	Time	Method
Seroconversion rate of neutralizing antibody	84 days after each dose	Neutralizing antibody assay will be performed after each dose of the vaccine
Incidence of adverse reactions	7 days after each dose	Incidence of adverse reactions after each dose of the vaccine

Trial Locations

Locations (1)

Zagazig University Faculty of Medicine; 🇪🇬 Zagazig, Sharkia, Egypt