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COVID-19NCT04743388

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

An observational study of COVID-19 and Healthy Volunteers, run by National and Kapodistrian University of Athens at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, Healthy Volunteers, Chronic Disease
What is being tested?
BNT162b2 and Other vaccine against SARS-Cov-2
Type of treatment
Vaccines
How many people
600 participants
Where
1 siteGreece
Study dates
4 Jan 2021to Dec 2022
How long will I take part?
18 Months
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Serious allergy problems i.e. hospitalization due to a serious allergic reaction (anaphylaxis)

Trial locations and contacts

1 site in 1 country.

Ioanna Charitaki contact

+30 6976156403

j.charitaki@gmail.com

Greece1 site, 1 recruiting

  • Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA

    Athens

    Evangelos Terpos, MD

    Recruiting

Other trials in Greece

About this study

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

Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.

Read the 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.

Being tested
BNT162b2, Other vaccine against SARS-Cov-2
Keywords
COVID-19, BNT162b2 vaccine, Antibodies, SARS-CoV-2
Medical subject headings
COVID-19, Chronic Disease, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT162b2Biological

    Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies

  • Other vaccine against SARS-Cov-2Biological

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

Study groups in NCT04743388
Study groupRoleWhat they receive
Cohort 1Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
Receives: Biological: BNT162b2; Biological: Other vaccine against SARS-Cov-2
Cohort 2People 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).
Receives: Biological: BNT162b2; Biological: Other vaccine against SARS-Cov-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neutralizing antibodies against SARS-CoV-2

    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

    Measured: Day 50 (28 days after the second dose of the vaccine)

Secondary outcomes (82)

  1. Neutralizing antibodies against SARS-CoV-2

    Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)

    Measured: Day 1

  2. Neutralizing antibodies against SARS-CoV-2

    Development of neutralizing antibodies against SARS-CoV-2 on day 8

    Measured: Day 8

  3. Neutralizing antibodies against SARS-CoV-2

    Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)

    Measured: Day 22

  4. Neutralizing antibodies against SARS-CoV-2

    Development of neutralizing antibodies against SARS-CoV-2 on day 36

    Measured: Day 36

  5. Neutralizing antibodies against SARS-CoV-2

    Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine

    Measured: Month 3

  6. Neutralizing antibodies against SARS-CoV-2

    Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine

    Measured: Month 6

  7. Neutralizing antibodies against SARS-CoV-2

    Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine

    Measured: Month 9

  8. Neutralizing antibodies against SARS-CoV-2

    Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine

    Measured: Month 12

  9. Neutralizing antibodies against SARS-CoV-2

    Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine

    Measured: Month 18

  10. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)

    Measured: Day 1

  11. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8

    Measured: Day 8

  12. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)

    Measured: Day 22

  13. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36

    Measured: Day 36

  14. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50

    Measured: Day 50

  15. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine

    Measured: Month 3

  16. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine

    Measured: Month 6

  17. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine

    Measured: Month 9

  18. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine

    Measured: Month 12

  19. Development of anti-S-RBD antibodies against SARS-CoV-2

    Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine

    Measured: Month 18

  20. Number of memory B-cells against SARS-CoV-2

    According to antibody responses on day 1

    Measured: Day 1

  21. Number of memory B-cells against SARS-CoV-2

    According to antibody responses on day 8

    Measured: Day 8

  22. Number of memory B-cells against SARS-CoV-2

    According to antibody responses on day 22 (before the second dose of the vaccine)

    Measured: Day 22

  23. Number of memory B-cells against SARS-CoV-2

    According to antibody responses on day 36

    Measured: Day 36

  24. Number of memory B-cells against SARS-CoV-2

    According to antibody responses on day 50

    Measured: Day 50

  25. Number of memory B-cells against SARS-CoV-2

    According to antibody responses at 3 months post the second dose of the vaccine

    Measured: Month 3

  26. Number of memory B-cells against SARS-CoV-2

    According to antibody responses at 6 months post the second dose of the vaccine

    Measured: Month 6

  27. Number of memory B-cells against SARS-CoV-2

    According to antibody responses at 9 months post the second dose of the vaccine

    Measured: Month 9

  28. Number of memory B-cells against SARS-CoV-2

    According to antibody responses at 12 months post the second dose of the vaccine

    Measured: Month 12

  29. Number of memory B-cells against SARS-CoV-2

    According to antibody responses at 18 months post the second dose of the vaccine

    Measured: Month 18

  30. Number of memory T-cells against SARS-CoV-2

    According to antibody responses on day 1

    Measured: Day 1

  31. Number of memory T-cells against SARS-CoV-2

    According to antibody responses on day 8

    Measured: Day 8

  32. Number of memory T-cells against SARS-CoV-2

    According to antibody responses on day 22 (before the second dose of the vaccine)

    Measured: Day 22

  33. Number of memory T-cells against SARS-CoV-2

    According to antibody responses on day 36

    Measured: Day 36

  34. Number of memory T-cells against SARS-CoV-2

    According to antibody responses on day 50

    Measured: Day 50

  35. Number of memory T-cells against SARS-CoV-2

    According to antibody responses at 3 months post the second dose of the vaccine

    Measured: Month 3

  36. Number of memory T-cells against SARS-CoV-2

    According to antibody responses at 6 months post the second dose of the vaccine

    Measured: Month 6

  37. Number of memory T-cells against SARS-CoV-2

    According to antibody responses at 9 months post the second dose of the vaccine

    Measured: Month 9

  38. Number of memory T-cells against SARS-CoV-2

    According to antibody responses at 12 months post the second dose of the vaccine

    Measured: Month 12

  39. Number of memory T-cells against SARS-CoV-2

    According to antibody responses at 18 months post the second dose of the vaccine

    Measured: Month 18

  40. Number of monocytes (CD14+, CD16+)

    According to antibody responses on day 1

    Measured: Day 1

  41. Number of monocytes (CD14+, CD16+)

    According to antibody responses on day 8

    Measured: Day 8

  42. Number of monocytes (CD14+, CD16+)

    According to antibody responses on day 22 (before the second dose of the vaccine)

    Measured: Day 22

  43. Number of monocytes (CD14+, CD16+)

    According to antibody responses on day 36

    Measured: Day 36

  44. Number of monocytes (CD14+, CD16+)

    According to antibody responses on day 50

    Measured: Day 50

  45. Number of monocytes (CD14+, CD16+)

    According to antibody responses at 3 months post the second dose of the vaccine

    Measured: Month 3

  46. Number of monocytes (CD14+, CD16+)

    According to antibody responses at 6 months post the second dose of the vaccine

    Measured: Month 6

  47. Number of monocytes (CD14+, CD16+)

    According to antibody responses at 9 months post the second dose of the vaccine

    Measured: Month 9

  48. Number of monocytes (CD14+, CD16+)

    According to antibody responses at 12 months post the second dose of the vaccine

    Measured: Month 12

  49. Number of monocytes (CD14+, CD16+)

    According to antibody responses at 18 months post the second dose of the vaccine

    Measured: Month 18

  50. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)

    Measured: Day 1

  51. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements on day 8

    Measured: Day 8

  52. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)

    Measured: Day 22

  53. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements on day 23

    Measured: Day 23

  54. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements on day 36

    Measured: Day 36

  55. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements on day 50

    Measured: Day 50

  56. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements at 3 months post the second dose of the vaccine

    Measured: Month 3

  57. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements at 6 months post the second dose of the vaccine

    Measured: Month 6

  58. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements at 9 months post the second dose of the vaccine

    Measured: Month 9

  59. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements at 12 months post the second dose of the vaccine

    Measured: Month 12

  60. Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels

    Inflammatory cytokines measurements at 18 months post the second dose of the vaccine

    Measured: Month 18

  61. TNF-a levels

    Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)

    Measured: Day 1

  62. TNF-a levels

    Inflammatory cytokines measurements on day 8

    Measured: Day 8

  63. TNF-a levels

    Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)

    Measured: Day 22

  64. TNF-a levels

    Inflammatory cytokines measurements on day 23

    Measured: Day 23

  65. TNF-a levels

    Inflammatory cytokines measurements on day 36

    Measured: Day 36

  66. TNF-a levels

    Inflammatory cytokines measurements on day 50

    Measured: Day 50

  67. TNF-a levels

    Inflammatory cytokines measurements at 3 months post the second dose of the vaccine

    Measured: Month 3

  68. TNF-a levels

    Inflammatory cytokines measurements at 6 months post the second dose of the vaccine

    Measured: Month 6

  69. TNF-a levels

    Inflammatory cytokines measurements at 9 months post the second dose of the vaccine

    Measured: Month 9

  70. TNF-a levels

    Inflammatory cytokines measurements at 12 months post the second dose of the vaccine

    Measured: Month 12

  71. TNF-a levels

    Inflammatory cytokines measurements at 18 months post the second dose of the vaccine

    Measured: Month 18

  72. CRP levels

    CRP blood level measurements on day 1 (before the first dose of the vaccine)

    Measured: Day 1

  73. CRP levels

    CRP blood level measurements on day 8

    Measured: Day 8

  74. CRP levels

    CRP blood level measurements on day 22 (before the second dose of the vaccine)

    Measured: Day 22

  75. CRP levels

    CRP blood level measurements on day 23

    Measured: Day 23

  76. CRP levels

    CRP blood level measurements on day 36

    Measured: Day 36

  77. CRP levels

    CRP blood level measurements on day 50

    Measured: Day 50

  78. CRP levels

    Inflammatory cytokines measurements at 3 months post the second dose of the vaccine

    Measured: Month 3

  79. CRP levels

    Inflammatory cytokines measurements at 6 months post the second dose of the vaccine

    Measured: Month 6

  80. CRP levels

    Inflammatory cytokines measurements at 9 months post the second dose of the vaccine

    Measured: Month 9

  81. CRP levels

    Inflammatory cytokines measurements at 12 months post the second dose of the vaccine

    Measured: Month 12

  82. CRP levels

    Inflammatory cytokines measurements at 18 months post the second dose of the vaccine

    Measured: Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start4 Jan 2021
  3. Primary completionAug 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04743388
Sponsor's protocol ID
900/24-12-2020
Status last verified
Apr 2022
First submitted
3 Feb 2021
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: At the end of the study, the results will be announced in medical conferences or medical journals.

Publications

  • Rosati M, Terpos E, Homan P, Bergamaschi C, Karaliota S, Ntanasis-Stathopoulos I, Devasundaram S, Bear J, Burns R, Bagratuni T, Trougakos IP, Dimopoulos MA, Pavlakis GN, Felber BK. Rapid transient and longer-lasting innate cytokine changes associated with adaptive immunity after repeated SARS-CoV-2 BNT162b2 mRNA vaccinations. Front Immunol. 2023 Nov 27;14:1292568. doi: 10.3389/fimmu.2023.1292568. eCollection 2023.

    PubMed 38090597

  • Terpos E, Fotiou D, Karalis V, Ntanasis-Stathopoulos I, Sklirou AD, Gavriatopoulou M, Malandrakis P, Iconomidou VA, Kastritis E, Trougakos IP, Dimopoulos MA. SARS-CoV-2 humoral responses following booster BNT162b2 vaccination in patients with B-cell malignancies. Am J Hematol. 2022 Oct;97(10):1300-1308. doi: 10.1002/ajh.26669. Epub 2022 Aug 2.

    PubMed 35871310

  • 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.

    PubMed 35406806

  • 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.

    PubMed 34529762

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