Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
8 de abril de 2022 actualizado por: Prof Evangelos Terpos, National and Kapodistrian University of Athens
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
Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Anticipado)
600
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ioanna Charitaki
- Número de teléfono: +30 6976156403
- Correo electrónico: j.charitaki@gmail.com
Ubicaciones de estudio
-
-
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Athens, Grecia
- Reclutamiento
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
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Contacto:
- Evangelos Terpos, MD
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
|
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
|
|
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).
|
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Day 50 (28 days after the second dose of the vaccine)
|
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
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Day 50 (28 days after the second dose of the vaccine)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Day 1
|
Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
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Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Day 8
|
Development of neutralizing antibodies against SARS-CoV-2 on day 8
|
Day 8
|
|
Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Day 22
|
Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
|
Day 22
|
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Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Day 36
|
Development of neutralizing antibodies against SARS-CoV-2 on day 36
|
Day 36
|
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Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Month 3
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Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
|
Month 3
|
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Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Month 6
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Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
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Month 6
|
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Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Month 9
|
Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
|
Month 9
|
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Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Month 12
|
Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
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Neutralizing antibodies against SARS-CoV-2
Periodo de tiempo: Month 18
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Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
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Month 18
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Day 1
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Day 8
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8
|
Day 8
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Day 22
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
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Day 22
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Day 36
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36
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Day 36
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Day 50
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50
|
Day 50
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Month 3
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
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Month 3
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Month 6
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
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Month 6
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Month 9
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
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Month 9
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Month 12
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
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Month 12
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Development of anti-S-RBD antibodies against SARS-CoV-2
Periodo de tiempo: Month 18
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
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Month 18
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Day 1
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According to antibody responses on day 1
|
Day 1
|
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Day 8
|
According to antibody responses on day 8
|
Day 8
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Day 22
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According to antibody responses on day 22 (before the second dose of the vaccine)
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Day 22
|
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Day 36
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According to antibody responses on day 36
|
Day 36
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Day 50
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According to antibody responses on day 50
|
Day 50
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Month 3
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According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Month 6
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According to antibody responses at 6 months post the second dose of the vaccine
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Month 6
|
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Month 9
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According to antibody responses at 9 months post the second dose of the vaccine
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Month 9
|
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Month 12
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According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
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Number of memory B-cells against SARS-CoV-2
Periodo de tiempo: Month 18
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According to antibody responses at 18 months post the second dose of the vaccine
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Month 18
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Day 1
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According to antibody responses on day 1
|
Day 1
|
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Day 8
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According to antibody responses on day 8
|
Day 8
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Day 22
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According to antibody responses on day 22 (before the second dose of the vaccine)
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Day 22
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Day 36
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According to antibody responses on day 36
|
Day 36
|
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Day 50
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According to antibody responses on day 50
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Day 50
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Month 3
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According to antibody responses at 3 months post the second dose of the vaccine
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Month 3
|
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Month 6
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According to antibody responses at 6 months post the second dose of the vaccine
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Month 6
|
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Month 9
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According to antibody responses at 9 months post the second dose of the vaccine
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Month 9
|
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Month 12
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According to antibody responses at 12 months post the second dose of the vaccine
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Month 12
|
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Number of memory T-cells against SARS-CoV-2
Periodo de tiempo: Month 18
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According to antibody responses at 18 months post the second dose of the vaccine
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Month 18
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Day 1
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According to antibody responses on day 1
|
Day 1
|
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Day 8
|
According to antibody responses on day 8
|
Day 8
|
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Day 22
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According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Day 36
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According to antibody responses on day 36
|
Day 36
|
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Day 50
|
According to antibody responses on day 50
|
Day 50
|
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Month 9
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According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Month 12
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According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
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Number of monocytes (CD14+, CD16+)
Periodo de tiempo: Month 18
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According to antibody responses at 18 months post the second dose of the vaccine
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Month 18
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Day 22
|
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
Periodo de tiempo: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Month 12
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Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Periodo de tiempo: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
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TNF-a levels
Periodo de tiempo: Day 1
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Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
Periodo de tiempo: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
Periodo de tiempo: Day 22
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Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
Periodo de tiempo: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
Periodo de tiempo: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
Periodo de tiempo: Day 50
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Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
Periodo de tiempo: Month 3
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Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
Periodo de tiempo: Month 6
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Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
Periodo de tiempo: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
Periodo de tiempo: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
TNF-a levels
Periodo de tiempo: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
CRP levels
Periodo de tiempo: Day 1
|
CRP blood level measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
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CRP levels
Periodo de tiempo: Day 8
|
CRP blood level measurements on day 8
|
Day 8
|
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CRP levels
Periodo de tiempo: Day 22
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CRP blood level measurements on day 22 (before the second dose of the vaccine)
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Day 22
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CRP levels
Periodo de tiempo: Day 23
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CRP blood level measurements on day 23
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Day 23
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CRP levels
Periodo de tiempo: Day 36
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CRP blood level measurements on day 36
|
Day 36
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CRP levels
Periodo de tiempo: Day 50
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CRP blood level measurements on day 50
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Day 50
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CRP levels
Periodo de tiempo: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
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Month 3
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CRP levels
Periodo de tiempo: Month 6
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Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
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Month 6
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CRP levels
Periodo de tiempo: Month 9
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Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
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Month 9
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CRP levels
Periodo de tiempo: Month 12
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Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
CRP levels
Periodo de tiempo: Month 18
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Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
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Month 18
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Evangelos Terpos, National and Kapodistrian University of Athens
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de enero de 2021
Finalización primaria (Anticipado)
1 de agosto de 2022
Finalización del estudio (Anticipado)
1 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
3 de febrero de 2021
Primero enviado que cumplió con los criterios de control de calidad
5 de febrero de 2021
Publicado por primera vez (Actual)
8 de febrero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
8 de abril de 2022
Última verificación
1 de abril de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Neoplasias
- Neumonía Viral
- Neumonía
- Enfermedades pulmonares
- Neoplasias por sitio
- Atributos de la enfermedad
- Enfermedades hematológicas
- COVID-19
- Neoplasias Hematológicas
- Enfermedad crónica
Otros números de identificación del estudio
- 900/24-12-2020
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
At the end of the study, the results will be announced in medical conferences or medical journals.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .