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OpenTrials
Completed

NCT Number: NCT04756271

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

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.

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Key information

Conditions

Vaccine Adverse Reaction Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Seroconversion Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SARS-Cov-2 neutralizing antibody titer

Biological

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

Primary outcomes

  1. Incidence of adverse reactions

    Time frame: 7 days after each dose

    Incidence of adverse reactions after each dose of the vaccine

  2. Seroconversion rate of neutralizing antibody

    Time frame: 84 days after each dose

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 16, 2021
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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