Comparative Study of Patterns of Immune Response to COVID 19 Vaccination
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Immunocompetent 100 healthy persons not suffering of any systemic diseases or malignancy of whatever nature. |
Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)
Vaccination
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| Immunocompromised 100 B thalassemia splenectomised patients. |
Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)
Vaccination
|
Outcome Measures
Primary Outcome Measures
- Studying the immune response to COVID -19 vaccination [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 [Month 3 - Month 9 of the study]
Secondary Outcome Measures
- . Determination of the most immunogenic parts of COVID 19 vaccine [Month 3-Month 9 of the study]
Detecting the most immunogenic epitopes located within the spike protein of the vaccines through ELispot assay
Eligibility Criteria
Criteria
Inclusion Criteria:
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Both sexes.
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3 weeks post scheduled first vaccination dose
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Healthy group not suffering from any systemic diseases.
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B thalassemia major splenectomized group
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Signing an informed consent .
Exclusion Criteria:
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 .
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Research Center | Cairo | Dokki | Egypt |
Sponsors and Collaborators
- National Research Centre, Egypt
- The holding company for biological products and vaccines (VACSERA)
- Theodor Bilharz Research Institute
Investigators
- Principal Investigator: Mohamed A Mokhles, Professor, National Research Center .
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 03/22-0001