COVID-19 VaccinesNCT04706143
Immunologic Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians
An observational study of COVID-19 Vaccines, run by Assiut University.
Trial summary
The recent Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and development of safe, effective vaccines is mandatory to return back to pre pandemic life. Many vaccines have been developed and requested by the authorities after the emergency license issued. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- COVID-19 Vaccines
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 1 Aug 2021
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adults aged from 25-65 years old non immune-compromised or immune suppressed receiving COVID-19 vaccines
Who may be able to join
- healthy adults receiving COVID-19 vaccines
Who cannot join
- any contraindication of each COVID-19 vaccine as listed by WHO
About this study
Official title: T Cell, Antibody and Cytokine Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians
The recent Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and development of safe, effective vaccines is mandatory to return back to pre pandemic life. Many vaccines have been developed and requested by the authorities after the emergency license issued. The main mechanism of protection is through humoral and cell-mediated immune responses that might reduce the potential for disease development or severity. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection. Preliminary data are now available indicating safty and effecacy of different vaccines . The vaccines were tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. The aim of this work is to evaluate the immune responses in adults, aged 25-65 years, up to 8 weeks after vaccination with a single and double doses live inactivated (Sinopharm), mRNA (Pfizer/ Biontech) and viral vector (Oxford/AZ- ChAdOx1 nCoV-19) vaccines. The Th1- response ( interferon-γ and tumor necrosis factor-α cytokine secretion by CD4+ T cells) and antibody production predominantly of IgG1 and IgG3 subclasses as well as CD8+ T cells mono, polyfunctional and cytotoxic phenotypes, will be also measured.
- Conditions
- COVID-19 Vaccines
- Being tested
- COVID-19 Vaccines
- Keywords
- COVID-19, Safety, Efficacy, T cell responses, Cytokine responses, Antibody responses
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccinesBiological
different available vaccines: live inactivated, mRNA and viral vector vaccines
| Study group | Role | What they receive |
|---|---|---|
| Vaccined group by live attenuated or viral vector or mRNA vaccine | Adults between 25-65 years old Receives: Biological: COVID-19 Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure immune cell activation induced by the vaccine
estimate number of lymphocytes, T cells, Natural killer cells and B cells
Measured: 8 weeks
measure antibody response to vaccines
evaluation of IgG and IgM levels, mg/dl
Measured: 8 weeks
measure the cytokine response to different vaccines
level of IL-1, IL-2, TNF-alpha, IFN- gamma, My/dl
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706143
- Sponsor's protocol ID
- AssiutU21
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Cell, Antibody and Cytokine Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians
- ClinicalTrials.gov ID
- NCT04706143
- Acronym / sponsor ID
- AssiutU21
- Conditions
- COVID-19 Vaccines
- Keywords
- COVID-19, Safety, Efficacy, T cell responses, Cytokine responses, Antibody responses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 12 Jan 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.
The recent Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and development of safe, effective vaccines is mandatory to return back to pre pandemic life. Many vaccines have been developed and requested by the authorities after the emergency license issued. The main mechanism of protection is through humoral and cell-mediated immune responses that might reduce the potential for disease development or severity. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection. Preliminary data are now available indicating safty and effecacy of different vaccines . The vaccines were tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. The aim of this work is to evaluate the immune responses in adults, aged 25-65 years, up to 8 weeks after vaccination with a single and double doses live inactivated (Sinopharm), mRNA (Pfizer/ Biontech) and viral vector (Oxford/AZ- ChAdOx1 nCoV-19) vaccines. The Th1- response ( interferon-γ and tumor necrosis factor-α cytokine secretion by CD4+ T cells) and antibody production predominantly of IgG1 and IgG3 subclasses as well as CD8+ T cells mono, polyfunctional and cytotoxic phenotypes, will be also measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccined group by live attenuated or viral vector or mRNA vaccine | – | Biological: COVID-19 VaccinesAdults between 25-65 years old |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adults aged from 25-65 years old non immune-compromised or immune suppressed receiving COVID-19 vaccines
Key inclusion criteria (1 listed)
- healthy adults receiving COVID-19 vaccines
Key exclusion criteria (1 listed)
- any contraindication of each COVID-19 vaccine as listed by WHO
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 |
|---|---|---|
| COVID-19 Vaccinesdifferent available vaccines: live inactivated, mRNA and viral vector vaccines | Biological | Vaccined group by live attenuated or viral vector or mRNA vaccine |
Primary outcome
measure immune cell activation induced by the vaccine
Time frame: 8 weeks
estimate number of lymphocytes, T cells, Natural killer cells and B cells
measure antibody response to vaccines
Time frame: 8 weeks
evaluation of IgG and IgM levels, mg/dl
measure the cytokine response to different vaccines
Time frame: 8 weeks
level of IL-1, IL-2, TNF-alpha, IFN- gamma, My/dl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: Yes. On request
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccines, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
measure immune cell activation induced by the vaccine (time frame: 8 weeks). The study lists 3 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 14 Jan 2021.