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Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.
The purpose of this study is to assess the kinetics of antibodies against SARS-CoV-2 as well as the kinetics of the immune system's cell subpopulations and cytokines associated with the immune system in healthy volunteers receiving the BNT162b2 vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies or any other vaccine authorized and administered by the Ministry of Health. Immunoassays will be performed at serum collection points before and after vaccination, as set out in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders. |
| |
| Cohort 2 | People with hematological malignancies or solid tumors in various phases of their treatment (under treatment or in remission/ follow-up). This cohort may include patients with smoldering multiple myeloma (n=50), multiple myeloma (n=140), chronic lymphocytic leukemia (with or without hypoglobulinemia) (n=50), lymphoma (n=80), AL amyloidosis (n=30), patients who receive PARP (n=30), CDK4/6 (n=30), or immune checkpoint inhibitors (n=40), and patients under therapy with Androgen Receptor Targeted Agents (n=50). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 | Biological | Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibodies against SARS-CoV-2 | Primary endpoint of the study is the development of neutralizing antibodies against SARS-CoV-2 on Day 50 28 days after the second dose of the vaccine) in the study populations | Day 50 (28 days after the second dose of the vaccine) |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibodies against SARS-CoV-2 | Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine) | Day 1 |
| Neutralizing antibodies against SARS-CoV-2 |
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Inclusion Criteria:
Exclusion Criteria:
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The admission criteria include both healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine. In particular, the study includes people with hematological malignancies or solid tumors, either receiving treatment or in remission/ follow-up, pursuant to the vaccination instructions of the Ministry of Health. The study will also include patients with autoimmune diseases who receive or do not receive treatment for their disease. Patients with diabetes mellitus, hypertension, heart disease, chronic renal failure of all stages (and undergoing dialysis) or other chronic diseases deemed suitable for vaccination, according to the instructions of the Ministry of Health, may also participate in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ioanna Charitaki | Contact | +30 6976156403 | j.charitaki@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Evangelos Terpos | National and Kapodistrian University of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA | Recruiting | Athens | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38090597 | Derived | Rosati M, Terpos E, Homan P, Bergamaschi C, Karaliota S, Ntanasis-Stathopoulos I, Devasundaram S, Bear J, Burns R, Bagratuni T, Trougakos IP, Dimopoulos MA, Pavlakis GN, Felber BK. Rapid transient and longer-lasting innate cytokine changes associated with adaptive immunity after repeated SARS-CoV-2 BNT162b2 mRNA vaccinations. Front Immunol. 2023 Nov 27;14:1292568. doi: 10.3389/fimmu.2023.1292568. eCollection 2023. | |
| 35871310 |
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At the end of the study, the results will be announced in medical conferences or medical journals.
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Blood samples (whole blood)
| Other vaccine against SARS-Cov-2 | Biological | Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2 |
|
Development of neutralizing antibodies against SARS-CoV-2 on day 8
| Day 8 |
| Neutralizing antibodies against SARS-CoV-2 | Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine) | Day 22 |
| Neutralizing antibodies against SARS-CoV-2 | Development of neutralizing antibodies against SARS-CoV-2 on day 36 | Day 36 |
| Neutralizing antibodies against SARS-CoV-2 | Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine | Month 3 |
| Neutralizing antibodies against SARS-CoV-2 | Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine | Month 6 |
| Neutralizing antibodies against SARS-CoV-2 | Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine | Month 9 |
| Neutralizing antibodies against SARS-CoV-2 | Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine | Month 12 |
| Neutralizing antibodies against SARS-CoV-2 | Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine | Month 18 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine) | Day 1 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8 | Day 8 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine) | Day 22 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36 | Day 36 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50 | Day 50 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine | Month 3 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine | Month 6 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine | Month 9 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine | Month 12 |
| Development of anti-S-RBD antibodies against SARS-CoV-2 | Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine | Month 18 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses on day 1 | Day 1 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses on day 8 | Day 8 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses on day 22 (before the second dose of the vaccine) | Day 22 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses on day 36 | Day 36 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses on day 50 | Day 50 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses at 3 months post the second dose of the vaccine | Month 3 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses at 6 months post the second dose of the vaccine | Month 6 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses at 9 months post the second dose of the vaccine | Month 9 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses at 12 months post the second dose of the vaccine | Month 12 |
| Number of memory B-cells against SARS-CoV-2 | According to antibody responses at 18 months post the second dose of the vaccine | Month 18 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses on day 1 | Day 1 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses on day 8 | Day 8 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses on day 22 (before the second dose of the vaccine) | Day 22 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses on day 36 | Day 36 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses on day 50 | Day 50 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses at 3 months post the second dose of the vaccine | Month 3 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses at 6 months post the second dose of the vaccine | Month 6 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses at 9 months post the second dose of the vaccine | Month 9 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses at 12 months post the second dose of the vaccine | Month 12 |
| Number of memory T-cells against SARS-CoV-2 | According to antibody responses at 18 months post the second dose of the vaccine | Month 18 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses on day 1 | Day 1 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses on day 8 | Day 8 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses on day 22 (before the second dose of the vaccine) | Day 22 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses on day 36 | Day 36 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses on day 50 | Day 50 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses at 3 months post the second dose of the vaccine | Month 3 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses at 6 months post the second dose of the vaccine | Month 6 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses at 9 months post the second dose of the vaccine | Month 9 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses at 12 months post the second dose of the vaccine | Month 12 |
| Number of monocytes (CD14+, CD16+) | According to antibody responses at 18 months post the second dose of the vaccine | Month 18 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine) | Day 1 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements on day 8 | Day 8 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine) | Day 22 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements on day 23 | Day 23 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements on day 36 | Day 36 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements on day 50 | Day 50 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements at 3 months post the second dose of the vaccine | Month 3 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements at 6 months post the second dose of the vaccine | Month 6 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements at 9 months post the second dose of the vaccine | Month 9 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements at 12 months post the second dose of the vaccine | Month 12 |
| Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels | Inflammatory cytokines measurements at 18 months post the second dose of the vaccine | Month 18 |
| TNF-a levels | Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine) | Day 1 |
| TNF-a levels | Inflammatory cytokines measurements on day 8 | Day 8 |
| TNF-a levels | Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine) | Day 22 |
| TNF-a levels | Inflammatory cytokines measurements on day 23 | Day 23 |
| TNF-a levels | Inflammatory cytokines measurements on day 36 | Day 36 |
| TNF-a levels | Inflammatory cytokines measurements on day 50 | Day 50 |
| TNF-a levels | Inflammatory cytokines measurements at 3 months post the second dose of the vaccine | Month 3 |
| TNF-a levels | Inflammatory cytokines measurements at 6 months post the second dose of the vaccine | Month 6 |
| TNF-a levels | Inflammatory cytokines measurements at 9 months post the second dose of the vaccine | Month 9 |
| TNF-a levels | Inflammatory cytokines measurements at 12 months post the second dose of the vaccine | Month 12 |
| TNF-a levels | Inflammatory cytokines measurements at 18 months post the second dose of the vaccine | Month 18 |
| CRP levels | CRP blood level measurements on day 1 (before the first dose of the vaccine) | Day 1 |
| CRP levels | CRP blood level measurements on day 8 | Day 8 |
| CRP levels | CRP blood level measurements on day 22 (before the second dose of the vaccine) | Day 22 |
| CRP levels | CRP blood level measurements on day 23 | Day 23 |
| CRP levels | CRP blood level measurements on day 36 | Day 36 |
| CRP levels | CRP blood level measurements on day 50 | Day 50 |
| CRP levels | Inflammatory cytokines measurements at 3 months post the second dose of the vaccine | Month 3 |
| CRP levels | Inflammatory cytokines measurements at 6 months post the second dose of the vaccine | Month 6 |
| CRP levels | Inflammatory cytokines measurements at 9 months post the second dose of the vaccine | Month 9 |
| CRP levels | Inflammatory cytokines measurements at 12 months post the second dose of the vaccine | Month 12 |
| CRP levels | Inflammatory cytokines measurements at 18 months post the second dose of the vaccine | Month 18 |
| Derived |
| Terpos E, Fotiou D, Karalis V, Ntanasis-Stathopoulos I, Sklirou AD, Gavriatopoulou M, Malandrakis P, Iconomidou VA, Kastritis E, Trougakos IP, Dimopoulos MA. SARS-CoV-2 humoral responses following booster BNT162b2 vaccination in patients with B-cell malignancies. Am J Hematol. 2022 Oct;97(10):1300-1308. doi: 10.1002/ajh.26669. Epub 2022 Aug 2. |
| 35406806 | Derived | Dagla I, Iliou A, Benaki D, Gikas E, Mikros E, Bagratuni T, Kastritis E, Dimopoulos MA, Terpos E, Tsarbopoulos A. Plasma Metabolomic Alterations Induced by COVID-19 Vaccination Reveal Putative Biomarkers Reflecting the Immune Response. Cells. 2022 Apr 6;11(7):1241. doi: 10.3390/cells11071241. |
| 34529762 | Derived | Gavriatopoulou M, Terpos E, Ntanasis-Stathopoulos I, Briasoulis A, Gumeni S, Malandrakis P, Fotiou D, Migkou M, Theodorakakou F, Eleutherakis-Papaiakovou E, Kanellias N, Kastritis E, Trougakos IP, Dimopoulos MA. Poor neutralizing antibody responses in 106 patients with WM after vaccination against SARS-CoV-2: a prospective study. Blood Adv. 2021 Nov 9;5(21):4398-4405. doi: 10.1182/bloodadvances.2021005444. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D002908 | Chronic Disease |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
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