Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
8 avril 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
600
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ioanna Charitaki
- Numéro de téléphone: +30 6976156403
- E-mail: j.charitaki@gmail.com
Lieux d'étude
-
-
-
Athens, Grèce
- Recrutement
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
-
Contact:
- Evangelos Terpos, MD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Délai: 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
|
Day 50 (28 days after the second dose of the vaccine)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Délai: Day 1
|
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
Délai: Day 8
|
Development of neutralizing antibodies against SARS-CoV-2 on day 8
|
Day 8
|
|
Neutralizing antibodies against SARS-CoV-2
Délai: Day 22
|
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
Délai: Day 36
|
Development of neutralizing antibodies against SARS-CoV-2 on day 36
|
Day 36
|
|
Neutralizing antibodies against SARS-CoV-2
Délai: Month 3
|
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
Délai: Month 6
|
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
Délai: Month 9
|
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
Délai: Month 12
|
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
Délai: Month 18
|
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
Délai: Day 1
|
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
Délai: Day 8
|
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
Délai: Day 22
|
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
Délai: Day 36
|
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
Délai: Day 50
|
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
Délai: Month 3
|
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
Délai: Month 6
|
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
Délai: Month 9
|
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
Délai: Month 12
|
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
Délai: Month 18
|
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
Délai: Day 1
|
According to antibody responses on day 1
|
Day 1
|
|
Number of memory B-cells against SARS-CoV-2
Délai: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory B-cells against SARS-CoV-2
Délai: Day 22
|
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
Délai: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of memory B-cells against SARS-CoV-2
Délai: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of memory B-cells against SARS-CoV-2
Délai: Month 3
|
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
Délai: Month 6
|
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
Délai: Month 9
|
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
Délai: Month 12
|
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
Délai: Month 18
|
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
Délai: Day 1
|
According to antibody responses on day 1
|
Day 1
|
|
Number of memory T-cells against SARS-CoV-2
Délai: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory T-cells against SARS-CoV-2
Délai: Day 22
|
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
Délai: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of memory T-cells against SARS-CoV-2
Délai: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of memory T-cells against SARS-CoV-2
Délai: Month 3
|
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
Délai: Month 6
|
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
Délai: Month 9
|
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
Délai: Month 12
|
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
Délai: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Number of monocytes (CD14+, CD16+)
Délai: Day 1
|
According to antibody responses on day 1
|
Day 1
|
|
Number of monocytes (CD14+, CD16+)
Délai: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of monocytes (CD14+, CD16+)
Délai: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of monocytes (CD14+, CD16+)
Délai: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of monocytes (CD14+, CD16+)
Délai: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of monocytes (CD14+, CD16+)
Délai: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of monocytes (CD14+, CD16+)
Délai: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of monocytes (CD14+, CD16+)
Délai: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of monocytes (CD14+, CD16+)
Délai: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of monocytes (CD14+, CD16+)
Délai: Month 18
|
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
Délai: Day 1
|
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
Délai: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Délai: 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
Délai: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Délai: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Délai: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
TNF-a levels
Délai: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
Délai: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
Délai: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
Délai: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
Délai: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
Délai: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
Délai: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
Délai: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
Délai: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
Délai: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
TNF-a levels
Délai: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
CRP levels
Délai: Day 1
|
CRP blood level measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
CRP levels
Délai: Day 8
|
CRP blood level measurements on day 8
|
Day 8
|
|
CRP levels
Délai: Day 22
|
CRP blood level measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
CRP levels
Délai: Day 23
|
CRP blood level measurements on day 23
|
Day 23
|
|
CRP levels
Délai: Day 36
|
CRP blood level measurements on day 36
|
Day 36
|
|
CRP levels
Délai: Day 50
|
CRP blood level measurements on day 50
|
Day 50
|
|
CRP levels
Délai: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
CRP levels
Délai: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
CRP levels
Délai: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
CRP levels
Délai: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
CRP levels
Délai: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Evangelos Terpos, National and Kapodistrian University of Athens
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
4 janvier 2021
Achèvement primaire (Anticipé)
1 août 2022
Achèvement de l'étude (Anticipé)
1 décembre 2022
Dates d'inscription aux études
Première soumission
3 février 2021
Première soumission répondant aux critères de contrôle qualité
5 février 2021
Première publication (Réel)
8 février 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 avril 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 avril 2022
Dernière vérification
1 avril 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Tumeurs
- Pneumonie virale
- Pneumonie
- Maladies pulmonaires
- Tumeurs par site
- Attributs de la maladie
- Maladies hématologiques
- COVID-19 [feminine]
- Tumeurs hématologiques
- Maladie chronique
Autres numéros d'identification d'étude
- 900/24-12-2020
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
At the end of the study, the results will be announced in medical conferences or medical journals.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .