Immune Response to Covid 19 VaccinationNCT05408299
Comparative Study of Patterns of Immune Response to COVID 19 Vaccination
An observational study of Immune Response to Covid 19 Vaccination, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
An effective vaccine stands as the most effective way for controlling the COVID 19 pandemic , yet, immunogenic vaccine efficacy needs to be extensively studied . T cell responses against the structural proteins have been found to be the most immunogenic in peripheral blood mononuclear cells of convalescent SARS-CoV1… Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Immune Response to Covid 19 Vaccination
- What is being tested?
- Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2022to Mar 2023
- 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 15 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: The study will comprise 200 subjects divided into 2 groups; Group 1 : 100 healthy subjects not suffering of systemic diseases vaccinated at any of the MOH vaccination centers. Group 2: 100 B thalssemia splenectomised patients representing an immunocompromised cohort.
Who may be able to join
- Both sexes.
- 3 weeks post scheduled first vaccination dose
- Healthy group not suffering from any systemic diseases.
- B thalassemia major splenectomized group
- Signing an informed consent .
Who cannot join
- 1- Malignancy of whatever nature. 2- Systemic diseases apart from B thalassemia for the B thalassemia group. 3- Previous infection with COVID 19 . 4- Refusal to sign the informed consent .
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Research Center
Cairo, Dokki
Mohamed A Mokhles, Professor, +201223407520, mohamad.mokhles@gmail.com
Reeham H Dawood, Professor, +201004050989, rmhaemd@hotmail.com
About this study
Official title: Comparative Study of Patterns of Immune Response to COVID 19 Vaccination Between Immunocompetent and Immunocompromised Subjects
An effective vaccine stands as the most effective way for controlling the COVID 19 pandemic , yet, immunogenic vaccine efficacy needs to be extensively studied . T cell responses against the structural proteins have been found to be the most immunogenic in peripheral blood mononuclear cells of convalescent SARS-CoV1 patients which needs to be tested in SARS -COV2 vaccine efficacy studies alongside with the sustainability of humoral and cellular immune responses . Clinically , immunocompromised patients face drastic outcome of infections , which led the Advisory Committee on Immunization Practices (ACIP) - USA -and the Joint Committee on Vaccination and Immunisation (JCVI) -UK- recommend COVID-19 vaccination of immunocompromised , the WHO Strategic Advisory Group of Experts on Immunization (SAGE), recommended that the three vaccines(Pfizer ,Moderna and Astra Zeneca) can be used for individuals with high-risk comorbidities . Nevertheless, there is an unmet research need concerning the immune response towards COVID 19 vaccination in this population .
Based on the previous work of our team in designing B and T cell epitopes distributed over the S protein , we will study the immune response in the available vaccines in Egypt.
Read the detailed description
This proposed project is a joint collaboration between the National Research Center(NRC) , Hematology treatment unit of the holding company for biological products and vaccines (VACSERA) and Theodor Bilharz research institute . After a 1 month period of preparation , enrollment will start at month 2 (M2) over a 2 months enrollment window, where persons from 18-70 years old , of both sexes , having their first vaccination dose no more than 3 weeks of any of the available vaccines in Egypt will be enrolled into the project after signing an informed consent . Healthy persons not suffering from any systemic diseases will be enrolled from Theodor Bilharz vaccination center , and the Medical Researches Center of Excellence ( MRCE) at the NRC from the NRC vaccinated staff , while splenectomised B thalassemia patients will be enrolled from the hematology treatment unit at VACSERA . First visit will be performed 3 weeks post the first vaccination dose , while the second visit will be performed 3 weeks post the second vaccination dose , and the third visit will be performed 3 months post the second vaccination dose where ( 5 ) ml of blood will be withdrawn at each visit for the determination of the primary immune response at the first 2 visits and the sustainability of the immune response at the third visit . Enrolled persons will be instructed to contact the project logistics administrator upon experiencing any suspicious symptom of COVID 19 infection ( Fever- loss of taste and/or smell - myalgia - malaise - headache - diarrhea ) who will arrange for an additional visit where a PCR test for COVID 19 will be performed for the determination of breakthrough infections , and if positive this will be considered a primary end point and an additional ( 5) ml of blood will be withdrawn for testing for the immune status .
- Conditions
- Immune Response to Covid 19 Vaccination
- Being tested
- Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)Biological
Vaccination
| Study group | Role | What they receive |
|---|---|---|
| Immunocompetent | 100 healthy persons not suffering of any systemic diseases or malignancy of whatever nature. Receives: Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm) | |
| Immunocompromised | 100 B thalassemia splenectomised patients. Receives: Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Studying the immune response to COVID -19 vaccination
Detection of total induced IgG binding antibodies
Measured: Month 3-Month 9 of the study
. Comparing immune response to COVID 19 vaccination between healthy and immunocompromised groups
Measured: Month 3 - Month 9 of the study
Secondary outcomes (1)
. Determination of the most immunogenic parts of COVID 19 vaccine
Detecting the most immunogenic epitopes located within the spike protein of the vaccines through ELispot assay
Measured: Month 3-Month 9 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start20 Jun 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Response to Covid 19 VaccinationStudies of the same condition, open and under way.
- 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
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- The holding company for biological products and vaccines (VACSERA), Theodor Bilharz Research Institute
- Responsible party
- Principal investigator, Mohamed Aly Abd El Salam Mokhles, National Research Centre, Egypt
- Investigators
- Mohamed A Mokhles, Professor, Principal investigator, National Research Center .
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408299
- Sponsor's protocol ID
- 03/22-0001
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through published scientific papers that come out of the study , in addition to conferences presentations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Patterns of Immune Response to COVID 19 Vaccination Between Immunocompetent and Immunocompromised Subjects
- ClinicalTrials.gov ID
- NCT05408299
- Acronym / sponsor ID
- 03/22-0001
- Conditions
- Immune Response to Covid 19 Vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Collaborators
- The holding company for biological products and vaccines (VACSERA), Theodor Bilharz Research Institute
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 7 Jun 2022 (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.
An effective vaccine stands as the most effective way for controlling the COVID 19 pandemic , yet, immunogenic vaccine efficacy needs to be extensively studied . T cell responses against the structural proteins have been found to be the most immunogenic in peripheral blood mononuclear cells of convalescent SARS-CoV1 patients which needs to be tested in SARS -COV2 vaccine efficacy studies alongside with the sustainability of humoral and cellular immune responses . Clinically , immunocompromised patients face drastic outcome of infections , which led the Advisory Committee on Immunization Practices (ACIP) - USA -and the Joint Committee on Vaccination and Immunisation (JCVI) -UK- recommend COVID-19 vaccination of immunocompromised , the WHO Strategic Advisory Group of Experts on Immunization (SAGE), recommended that the three vaccines(Pfizer ,Moderna and Astra Zeneca) can be used for individuals with high-risk comorbidities . Nevertheless, there is an unmet research need concerning the immune response towards COVID 19 vaccination in this population .
Based on the previous work of our team in designing B and T cell epitopes distributed over the S protein , we will study the immune response in the available vaccines in Egypt.
Detailed description
This proposed project is a joint collaboration between the National Research Center(NRC) , Hematology treatment unit of the holding company for biological products and vaccines (VACSERA) and Theodor Bilharz research institute . After a 1 month period of preparation , enrollment will start at month 2 (M2) over a 2 months enrollment window, where persons from 18-70 years old , of both sexes , having their first vaccination dose no more than 3 weeks of any of the available vaccines in Egypt will be enrolled into the project after signing an informed consent . Healthy persons not suffering from any systemic diseases will be enrolled from Theodor Bilharz vaccination center , and the Medical Researches Center of Excellence ( MRCE) at the NRC from the NRC vaccinated staff , while splenectomised B thalassemia patients will be enrolled from the hematology treatment unit at VACSERA . First visit will be performed 3 weeks post the first vaccination dose , while the second visit will be performed 3 weeks post the second vaccination dose , and the third visit will be performed 3 months post the second vaccination dose where ( 5 ) ml of blood will be withdrawn at each visit for the determination of the primary immune response at the first 2 visits and the sustainability of the immune response at the third visit . Enrolled persons will be instructed to contact the project logistics administrator upon experiencing any suspicious symptom of COVID 19 infection ( Fever- loss of taste and/or smell - myalgia - malaise - headache - diarrhea ) who will arrange for an additional visit where a PCR test for COVID 19 will be performed for the determination of breakthrough infections , and if positive this will be considered a primary end point and an additional ( 5) ml of blood will be withdrawn for testing for the immune status .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunocompetent | – | Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)100 healthy persons not suffering of any systemic diseases or malignancy of whatever nature. |
| Immunocompromised | – | Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)100 B thalassemia splenectomised patients. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will comprise 200 subjects divided into 2 groups; Group 1 : 100 healthy subjects not suffering of systemic diseases vaccinated at any of the MOH vaccination centers. Group 2: 100 B thalssemia splenectomised patients representing an immunocompromised cohort.
Key inclusion criteria (5 listed)
- Both sexes.
- 3 weeks post scheduled first vaccination dose
- Healthy group not suffering from any systemic diseases.
- B thalassemia major splenectomized group
- Signing an informed consent .
Key exclusion criteria (2 listed)
- 1- Malignancy of whatever nature. 2- Systemic diseases apart from B thalassemia for the B thalassemia group. 3- Previous infection with COVID 19 . 4- Refusal to sign the informed consent .
- -
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 vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)Vaccination | Biological | Immunocompetent, Immunocompromised |
Primary outcome
Studying the immune response to COVID -19 vaccination
Time frame: Month 3-Month 9 of the study
Detection of total induced IgG binding antibodies
. Comparing immune response to COVID 19 vaccination between healthy and immunocompromised groups
Time frame: Month 3 - Month 9 of the study
1 secondary outcome
. Determination of the most immunogenic parts of COVID 19 vaccine
Time frame: Month 3-Month 9 of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: Yes. Data will be shared through published scientific papers that come out of the study , in addition to conferences presentations.
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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.
Mohamed A Mokhles, Professor principal investigator
National Research Center .
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Response to Covid 19 Vaccination, run by National Research Centre, Egypt 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 5 inclusion and 2 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 7 Jun 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.
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?
Contact Mohamed A Mokhles, Professor (+201223407520, mohamad.mokhles@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Studying the immune response to COVID -19 vaccination (time frame: Month 3-Month 9 of the study). 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 7 Jun 2022.