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Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743388
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Prof Evangelos Terpos, National and Kapodistrian University of Athens

Study Description
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Brief Summary:
Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.

Condition or disease Intervention/treatment
COVID-19 Healthy Volunteers Chronic Disease Hematological Malignancies Solid Tumor Biological: BNT162b2 Biological: Other vaccine against SARS-Cov-2

Detailed Description:
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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: 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
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
 Biological: BNT162b2
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies

Biological: Other vaccine against SARS-Cov-2
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).
 Biological: BNT162b2
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies

Biological: Other vaccine against SARS-Cov-2
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2


Outcome Measures
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Primary Outcome Measures :
  1. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: 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


Secondary Outcome Measures :
  1. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: Day 1 ]
    Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)

  2. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: Day 8 ]
    Development of neutralizing antibodies against SARS-CoV-2 on day 8

  3. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: Day 22 ]
    Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)

  4. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: Day 36 ]
    Development of neutralizing antibodies against SARS-CoV-2 on day 36

  5. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: Month 3 ]
    Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine

  6. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: Month 6 ]
    Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine

  7. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: Month 9 ]
    Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine

  8. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: Month 12 ]
    Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine

  9. Neutralizing antibodies against SARS-CoV-2 [ Time Frame: Month 18 ]
    Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine

  10. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Day 1 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)

  11. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Day 8 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8

  12. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Day 22 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)

  13. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Day 36 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36

  14. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Day 50 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50

  15. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Month 3 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine

  16. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Month 6 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine

  17. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Month 9 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine

  18. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Month 12 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine

  19. Development of anti-S-RBD antibodies against SARS-CoV-2 [ Time Frame: Month 18 ]
    Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine

  20. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Day 1 ]
    According to antibody responses on day 1

  21. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Day 8 ]
    According to antibody responses on day 8

  22. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Day 22 ]
    According to antibody responses on day 22 (before the second dose of the vaccine)

  23. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Day 36 ]
    According to antibody responses on day 36

  24. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Day 50 ]
    According to antibody responses on day 50

  25. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Month 3 ]
    According to antibody responses at 3 months post the second dose of the vaccine

  26. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Month 6 ]
    According to antibody responses at 6 months post the second dose of the vaccine

  27. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Month 9 ]
    According to antibody responses at 9 months post the second dose of the vaccine

  28. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Month 12 ]
    According to antibody responses at 12 months post the second dose of the vaccine

  29. Number of memory B-cells against SARS-CoV-2 [ Time Frame: Month 18 ]
    According to antibody responses at 18 months post the second dose of the vaccine

  30. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Day 1 ]
    According to antibody responses on day 1

  31. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Day 8 ]
    According to antibody responses on day 8

  32. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Day 22 ]
    According to antibody responses on day 22 (before the second dose of the vaccine)

  33. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Day 36 ]
    According to antibody responses on day 36

  34. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Day 50 ]
    According to antibody responses on day 50

  35. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Month 3 ]
    According to antibody responses at 3 months post the second dose of the vaccine

  36. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Month 6 ]
    According to antibody responses at 6 months post the second dose of the vaccine

  37. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Month 9 ]
    According to antibody responses at 9 months post the second dose of the vaccine

  38. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Month 12 ]
    According to antibody responses at 12 months post the second dose of the vaccine

  39. Number of memory T-cells against SARS-CoV-2 [ Time Frame: Month 18 ]
    According to antibody responses at 18 months post the second dose of the vaccine

  40. Number of monocytes (CD14+, CD16+) [ Time Frame: Day 1 ]
    According to antibody responses on day 1

  41. Number of monocytes (CD14+, CD16+) [ Time Frame: Day 8 ]
    According to antibody responses on day 8

  42. Number of monocytes (CD14+, CD16+) [ Time Frame: Day 22 ]
    According to antibody responses on day 22 (before the second dose of the vaccine)

  43. Number of monocytes (CD14+, CD16+) [ Time Frame: Day 36 ]
    According to antibody responses on day 36

  44. Number of monocytes (CD14+, CD16+) [ Time Frame: Day 50 ]
    According to antibody responses on day 50

  45. Number of monocytes (CD14+, CD16+) [ Time Frame: Month 3 ]
    According to antibody responses at 3 months post the second dose of the vaccine

  46. Number of monocytes (CD14+, CD16+) [ Time Frame: Month 6 ]
    According to antibody responses at 6 months post the second dose of the vaccine

  47. Number of monocytes (CD14+, CD16+) [ Time Frame: Month 9 ]
    According to antibody responses at 9 months post the second dose of the vaccine

  48. Number of monocytes (CD14+, CD16+) [ Time Frame: Month 12 ]
    According to antibody responses at 12 months post the second dose of the vaccine

  49. Number of monocytes (CD14+, CD16+) [ Time Frame: Month 18 ]
    According to antibody responses at 18 months post the second dose of the vaccine

  50. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Day 1 ]
    Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)

  51. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Day 8 ]
    Inflammatory cytokines measurements on day 8

  52. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Day 22 ]
    Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)

  53. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Day 23 ]
    Inflammatory cytokines measurements on day 23

  54. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Day 36 ]
    Inflammatory cytokines measurements on day 36

  55. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Day 50 ]
    Inflammatory cytokines measurements on day 50

  56. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Month 3 ]
    Inflammatory cytokines measurements at 3 months post the second dose of the vaccine

  57. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Month 6 ]
    Inflammatory cytokines measurements at 6 months post the second dose of the vaccine

  58. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Month 9 ]
    Inflammatory cytokines measurements at 9 months post the second dose of the vaccine

  59. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Month 12 ]
    Inflammatory cytokines measurements at 12 months post the second dose of the vaccine

  60. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels [ Time Frame: Month 18 ]
    Inflammatory cytokines measurements at 18 months post the second dose of the vaccine

  61. TNF-a levels [ Time Frame: Day 1 ]
    Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)

  62. TNF-a levels [ Time Frame: Day 8 ]
    Inflammatory cytokines measurements on day 8

  63. TNF-a levels [ Time Frame: Day 22 ]
    Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)

  64. TNF-a levels [ Time Frame: Day 23 ]
    Inflammatory cytokines measurements on day 23

  65. TNF-a levels [ Time Frame: Day 36 ]
    Inflammatory cytokines measurements on day 36

  66. TNF-a levels [ Time Frame: Day 50 ]
    Inflammatory cytokines measurements on day 50

  67. TNF-a levels [ Time Frame: Month 3 ]
    Inflammatory cytokines measurements at 3 months post the second dose of the vaccine

  68. TNF-a levels [ Time Frame: Month 6 ]
    Inflammatory cytokines measurements at 6 months post the second dose of the vaccine

  69. TNF-a levels [ Time Frame: Month 9 ]
    Inflammatory cytokines measurements at 9 months post the second dose of the vaccine

  70. TNF-a levels [ Time Frame: Month 12 ]
    Inflammatory cytokines measurements at 12 months post the second dose of the vaccine

  71. TNF-a levels [ Time Frame: Month 18 ]
    Inflammatory cytokines measurements at 18 months post the second dose of the vaccine

  72. CRP levels [ Time Frame: Day 1 ]
    CRP blood level measurements on day 1 (before the first dose of the vaccine)

  73. CRP levels [ Time Frame: Day 8 ]
    CRP blood level measurements on day 8

  74. CRP levels [ Time Frame: Day 22 ]
    CRP blood level measurements on day 22 (before the second dose of the vaccine)

  75. CRP levels [ Time Frame: Day 23 ]
    CRP blood level measurements on day 23

  76. CRP levels [ Time Frame: Day 36 ]
    CRP blood level measurements on day 36

  77. CRP levels [ Time Frame: Day 50 ]
    CRP blood level measurements on day 50

  78. CRP levels [ Time Frame: Month 3 ]
    Inflammatory cytokines measurements at 3 months post the second dose of the vaccine

  79. CRP levels [ Time Frame: Month 6 ]
    Inflammatory cytokines measurements at 6 months post the second dose of the vaccine

  80. CRP levels [ Time Frame: Month 9 ]
    Inflammatory cytokines measurements at 9 months post the second dose of the vaccine

  81. CRP levels [ Time Frame: Month 12 ]
    Inflammatory cytokines measurements at 12 months post the second dose of the vaccine

  82. CRP levels [ Time Frame: Month 18 ]
    Inflammatory cytokines measurements at 18 months post the second dose of the vaccine


Biospecimen Retention:   Samples With DNA
Blood samples (whole blood)

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743388


Contacts
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Contact: Ioanna Charitaki +30 6976156403 j.charitaki@gmail.com

Locations
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Greece
Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA Recruiting
Athens, Greece
Contact: Evangelos Terpos, MD         
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Evangelos Terpos National and Kapodistrian University of Athens
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof Evangelos Terpos, Professor of Therapeutics-Hematology, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT04743388    
Other Study ID Numbers: 900/24-12-2020
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At the end of the study, the results will be announced in medical conferences or medical journals.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prof Evangelos Terpos, National and Kapodistrian University of Athens:
COVID-19
BNT162b2 vaccine
Antibodies
SARS-CoV-2
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Hematologic Neoplasms
Chronic Disease
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms by Site
Hematologic Diseases