Clinical trial · Observational
Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
Study of the Kinetics of Antibodies Against SARS-CoV-2 and of Cellular Subpopulations of the Immune System in Volunteers Receiving the BNT162b2 Vaccine or Other Approved Vaccine Against SARS-CoV-2
NCT04743388CI-TRIAL-00057703unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Disease | — | UNRESOLVED | — |
| COVID-19 | — | UNRESOLVED | — |
| Healthy Volunteers | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BNT162b2 | Biological | — | UNRESOLVED |
| Other vaccine against SARS-Cov-2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
- interventionNames
- Biological: BNT162b2
- Biological: Other vaccine against SARS-Cov-2
- label
- Cohort 2
- description
- 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).
- interventionNames
- Biological: BNT162b2
- Biological: Other vaccine against SARS-Cov-2
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine * Age ≥ 18 years old Exclusion Criteria: * Serious allergy problems i.e. hospitalization due to a serious allergic reaction (anaphylaxis)
References
Publications (4)
- DERIVEDRosati 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. PMID 38090597
- DERIVEDTerpos 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. PMID 35871310
- DERIVEDDagla 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. PMID 35406806
- DERIVEDGavriatopoulou 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. PMID 34529762