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

NCT04756271 | Completed Phase 3

• 1 other identifier: 6738-14-2-21
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Adverse Reaction; Seroconversion

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse reactions

  Incidence of adverse reactions after each dose of the vaccine

  7 days after each dose

• Seroconversion rate of neutralizing antibody

  Neutralizing antibody assay will be performed after each dose of the vaccine

  84 days after each dose

Study Arms (1)

Health-care workers

EXPERIMENTAL

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 Blood samples will be withdrawn from them to investigate the immune response to the given vaccine

Biological: SARS-Cov-2 neutralizing antibody titer

Interventions

SARS-Cov-2 neutralizing antibody titer BIOLOGICAL

Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine

Health-care workers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy healthcare workers

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Noha M Hammad, MD

  Faculty of Medicine, Zagazig University , Zagazig, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 16, 2021
• Study Start: February 11, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 22, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)