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 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
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 estudo
Observacional
Inscrição (Antecipado)
600
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ioanna Charitaki
- Número de telefone: +30 6976156403
- E-mail: j.charitaki@gmail.com
Locais de estudo
-
-
-
Athens, Grécia
- Recrutamento
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
-
Contato:
- Evangelos Terpos, MD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Neutralizing antibodies against SARS-CoV-2
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Prazo: Day 1
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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
Prazo: Day 8
|
Development of neutralizing antibodies against SARS-CoV-2 on day 8
|
Day 8
|
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Neutralizing antibodies against SARS-CoV-2
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Day 1
|
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
Prazo: Day 8
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Day 1
|
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
Prazo: Day 8
|
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Day 8
|
According to antibody responses on day 8
|
Day 8
|
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Number of memory T-cells against SARS-CoV-2
Prazo: 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 memory T-cells against SARS-CoV-2
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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+)
Prazo: 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+)
Prazo: Day 8
|
According to antibody responses on day 8
|
Day 8
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Number of monocytes (CD14+, CD16+)
Prazo: Day 22
|
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+)
Prazo: Day 36
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According to antibody responses on day 36
|
Day 36
|
|
Number of monocytes (CD14+, CD16+)
Prazo: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of monocytes (CD14+, CD16+)
Prazo: 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+)
Prazo: 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+)
Prazo: Month 9
|
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+)
Prazo: 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+)
Prazo: 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
Prazo: Day 1
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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
Prazo: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Prazo: 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
Prazo: 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
Prazo: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Prazo: Day 50
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Inflammatory cytokines measurements on day 50
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Day 50
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
TNF-a levels
Prazo: Day 1
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Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
Prazo: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
Prazo: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
Prazo: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
Prazo: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
Prazo: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
Prazo: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
Prazo: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
Prazo: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
Prazo: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
TNF-a levels
Prazo: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
CRP levels
Prazo: Day 1
|
CRP blood level measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
CRP levels
Prazo: Day 8
|
CRP blood level measurements on day 8
|
Day 8
|
|
CRP levels
Prazo: Day 22
|
CRP blood level measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
CRP levels
Prazo: Day 23
|
CRP blood level measurements on day 23
|
Day 23
|
|
CRP levels
Prazo: Day 36
|
CRP blood level measurements on day 36
|
Day 36
|
|
CRP levels
Prazo: Day 50
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CRP blood level measurements on day 50
|
Day 50
|
|
CRP levels
Prazo: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
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CRP levels
Prazo: Month 6
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Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
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CRP levels
Prazo: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
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CRP levels
Prazo: 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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CRP levels
Prazo: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Evangelos Terpos, National and Kapodistrian University of Athens
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
4 de janeiro de 2021
Conclusão Primária (Antecipado)
1 de agosto de 2022
Conclusão do estudo (Antecipado)
1 de dezembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
3 de fevereiro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de fevereiro de 2021
Primeira postagem (Real)
8 de fevereiro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de abril de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de abril de 2022
Última verificação
1 de abril de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Infecções por coronavírus
- Infecções por Coronaviridae
- Infecções por Nidovírus
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções do Trato Respiratório
- Doenças Respiratórias
- Neoplasias
- Pneumonia Viral
- Pneumonia
- Doenças pulmonares
- Neoplasias por local
- Atributos da doença
- Doenças Hematológicas
- COVID-19
- Neoplasias Hematológicas
- Doença crônica
Outros números de identificação do estudo
- 900/24-12-2020
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
At the end of the study, the results will be announced in medical conferences or medical journals.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .