Vaccine Adverse ReactionPhase 3NCT04756271
Safety and Immunogenicity of Oxford AstraZeneca Vaccine Against COVID-19 Infection
A Phase 3 study testing SARS-Cov-2 neutralizing antibody titer in people with Vaccine Adverse Reaction and Seroconversion, run by Zagazig University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Adverse Reaction, Seroconversion
- What is being tested?
- SARS-Cov-2 neutralizing antibody titer
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Feb 2021to 22 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Healthy healthcare workers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University Faculty of Medicine
Zagazig, Sharqia Province, 44519
About this study
Official title: Safety and Immunogenicity of Oxford AstraZeneca Vaccine in Zagazig University Hospital Health-care Workers
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.
Read the 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
- Being tested
- SARS-Cov-2 neutralizing antibody titer
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-Cov-2 neutralizing antibody titerBiological
Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: SARS-Cov-2 neutralizing antibody titer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Incidence of adverse reactions after each dose of the vaccine
Measured: 7 days after each dose
Seroconversion rate of neutralizing antibody
Neutralizing antibody assay will be performed after each dose of the vaccine
Measured: 84 days after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start11 Feb 2021
- Primary completion20 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noha M Hammad, MD, Zagazig University
- Investigators
- Noha M Hammad, MD, Principal investigator, Faculty of Medicine, Zagazig University , Zagazig, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756271
- Sponsor's protocol ID
- 6738-14-2-21
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Oxford AstraZeneca Vaccine in Zagazig University Hospital Health-care Workers
- ClinicalTrials.gov ID
- NCT04756271
- Acronym / sponsor ID
- 6738-14-2-21
- Conditions
- Vaccine Adverse Reaction, Seroconversion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health-care workers | Experimental | Biological: SARS-Cov-2 neutralizing antibody titerHealthy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Healthy healthcare workers
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-Cov-2 neutralizing antibody titerQuantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine | Biological | Health-care workers |
Primary outcome
Incidence of adverse reactions
Time frame: 7 days after each dose
Incidence of adverse reactions after each dose of the vaccine
Seroconversion rate of neutralizing antibody
Time frame: 84 days after each dose
Neutralizing antibody assay will be performed after each dose of the vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha M Hammad, MD principal investigator
Faculty of Medicine, Zagazig University , Zagazig, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SARS-Cov-2 neutralizing antibody titer in people with Vaccine Adverse Reaction and Seroconversion, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: 7 days after each dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.