Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
perjantai 8. huhtikuuta 2022 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Odotettu)
600
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Ioanna Charitaki
- Puhelinnumero: +30 6976156403
- Sähköposti: j.charitaki@gmail.com
Opiskelupaikat
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Athens, Kreikka
- Rekrytointi
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
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Ottaa yhteyttä:
- Evangelos Terpos, MD
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
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.
Kuvaus
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)
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
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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
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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).
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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
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Neutralizing antibodies against SARS-CoV-2
Aikaikkuna: Day 50 (28 days after the second dose of the vaccine)
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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)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Neutralizing antibodies against SARS-CoV-2
Aikaikkuna: Day 1
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Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
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Day 1
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Neutralizing antibodies against SARS-CoV-2
Aikaikkuna: Day 8
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Development of neutralizing antibodies against SARS-CoV-2 on day 8
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Day 8
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Neutralizing antibodies against SARS-CoV-2
Aikaikkuna: Day 22
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Development of neutralizing 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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Neutralizing antibodies against SARS-CoV-2
Aikaikkuna: Day 36
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Development of neutralizing antibodies against SARS-CoV-2 on day 36
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Day 36
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Neutralizing antibodies against SARS-CoV-2
Aikaikkuna: Month 3
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Development of neutralizing 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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Neutralizing antibodies against SARS-CoV-2
Aikaikkuna: 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
Aikaikkuna: Month 9
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Development of neutralizing 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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Neutralizing antibodies against SARS-CoV-2
Aikaikkuna: Month 12
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Development of neutralizing 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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Neutralizing antibodies against SARS-CoV-2
Aikaikkuna: 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
Aikaikkuna: 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)
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Day 1
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Development of anti-S-RBD antibodies against SARS-CoV-2
Aikaikkuna: Day 8
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8
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Day 8
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Development of anti-S-RBD antibodies against SARS-CoV-2
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Day 50
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50
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Day 50
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Development of anti-S-RBD antibodies against SARS-CoV-2
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Day 1
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According to antibody responses on day 1
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Day 1
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Number of memory B-cells against SARS-CoV-2
Aikaikkuna: Day 8
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According to antibody responses on day 8
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Day 8
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Number of memory B-cells against SARS-CoV-2
Aikaikkuna: 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
Aikaikkuna: Day 36
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According to antibody responses on day 36
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Day 36
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Number of memory B-cells against SARS-CoV-2
Aikaikkuna: 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 B-cells against SARS-CoV-2
Aikaikkuna: 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 B-cells against SARS-CoV-2
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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 B-cells against SARS-CoV-2
Aikaikkuna: 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
Aikaikkuna: Day 1
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According to antibody responses on day 1
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Day 1
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Number of memory T-cells against SARS-CoV-2
Aikaikkuna: Day 8
|
According to antibody responses on day 8
|
Day 8
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Number of memory T-cells against SARS-CoV-2
Aikaikkuna: 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
Aikaikkuna: Day 36
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According to antibody responses on day 36
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Day 36
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Number of memory T-cells against SARS-CoV-2
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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+)
Aikaikkuna: Day 1
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According to antibody responses on day 1
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Day 1
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Number of monocytes (CD14+, CD16+)
Aikaikkuna: Day 8
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According to antibody responses on day 8
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Day 8
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Number of monocytes (CD14+, CD16+)
Aikaikkuna: 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+)
Aikaikkuna: Day 36
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According to antibody responses on day 36
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Day 36
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Number of monocytes (CD14+, CD16+)
Aikaikkuna: 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 monocytes (CD14+, CD16+)
Aikaikkuna: 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 monocytes (CD14+, CD16+)
Aikaikkuna: 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 monocytes (CD14+, CD16+)
Aikaikkuna: 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+)
Aikaikkuna: 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+)
Aikaikkuna: Month 18
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According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
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|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Aikaikkuna: 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
Aikaikkuna: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Aikaikkuna: 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
Aikaikkuna: Day 23
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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
Aikaikkuna: Day 36
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Inflammatory cytokines measurements on day 36
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Day 36
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Aikaikkuna: Day 50
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Inflammatory cytokines measurements on day 50
|
Day 50
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Aikaikkuna: Month 3
|
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
Aikaikkuna: Month 6
|
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
Aikaikkuna: Month 9
|
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
Aikaikkuna: Month 12
|
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
Aikaikkuna: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
TNF-a levels
Aikaikkuna: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
Aikaikkuna: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
Aikaikkuna: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
Aikaikkuna: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
Aikaikkuna: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
Aikaikkuna: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
Aikaikkuna: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
Aikaikkuna: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
Aikaikkuna: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
Aikaikkuna: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
TNF-a levels
Aikaikkuna: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
CRP levels
Aikaikkuna: Day 1
|
CRP blood level measurements on day 1 (before the first dose of the vaccine)
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Day 1
|
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CRP levels
Aikaikkuna: Day 8
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CRP blood level measurements on day 8
|
Day 8
|
|
CRP levels
Aikaikkuna: Day 22
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CRP blood level measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
CRP levels
Aikaikkuna: Day 23
|
CRP blood level measurements on day 23
|
Day 23
|
|
CRP levels
Aikaikkuna: Day 36
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CRP blood level measurements on day 36
|
Day 36
|
|
CRP levels
Aikaikkuna: Day 50
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CRP blood level measurements on day 50
|
Day 50
|
|
CRP levels
Aikaikkuna: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
CRP levels
Aikaikkuna: Month 6
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Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
CRP levels
Aikaikkuna: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
CRP levels
Aikaikkuna: Month 12
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Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
CRP levels
Aikaikkuna: 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
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: Evangelos Terpos, National and Kapodistrian University of Athens
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Maanantai 4. tammikuuta 2021
Ensisijainen valmistuminen (Odotettu)
Maanantai 1. elokuuta 2022
Opintojen valmistuminen (Odotettu)
Torstai 1. joulukuuta 2022
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 3. helmikuuta 2021
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 5. helmikuuta 2021
Ensimmäinen Lähetetty (Todellinen)
Maanantai 8. helmikuuta 2021
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 11. huhtikuuta 2022
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 8. huhtikuuta 2022
Viimeksi vahvistettu
Perjantai 1. huhtikuuta 2022
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Koronavirusinfektiot
- Coronaviridae-infektiot
- Nidovirales-infektiot
- RNA-virusinfektiot
- Virussairaudet
- Infektiot
- Hengitysteiden infektiot
- Hengityselinten sairaudet
- Neoplasmat
- Keuhkokuume, virus
- Keuhkokuume
- Keuhkosairaudet
- Neoplasmat sivustoittain
- Sairauden ominaisuudet
- Hematologiset sairaudet
- COVID-19
- Hematologiset kasvaimet
- Krooninen sairaus
Muut tutkimustunnusnumerot
- 900/24-12-2020
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
At the end of the study, the results will be announced in medical conferences or medical journals.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Joo
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .