Clinical trial NCT04743388: Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Healthy Volunteers
Chronic Disease
Hematological Malignancies
Solid Tumor
Keywords: COVID-19
BNT162b2 vaccine
Antibodies
SARS-CoV-2
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 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.

Eligibility 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)

Primary outcomes:
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Day 50 (28 days after the second dose of the vaccine)
Secondary outcomes:
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Day 1
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Day 8
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Day 22
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Day 36
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Month 3
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Month 6
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Month 9
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Month 12
measure: Neutralizing antibodies against SARS-CoV-2
timeFrame: Month 18
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Day 1
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Day 8
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Day 22
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Day 36
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Day 50
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Month 3
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Month 6
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Month 9
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Month 12
measure: Development of anti-S-RBD antibodies against SARS-CoV-2
timeFrame: Month 18
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Day 1
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Day 8
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Day 22
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Day 36
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Day 50
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Month 3
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Month 6
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Month 9
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Month 12
measure: Number of memory B-cells against SARS-CoV-2
timeFrame: Month 18
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Day 1
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Day 8
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Day 22
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Day 36
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Day 50
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Month 3
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Month 6
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Month 9
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Month 12
measure: Number of memory T-cells against SARS-CoV-2
timeFrame: Month 18
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Day 1
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Day 8
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Day 22
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Day 36
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Day 50
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Month 3
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Month 6
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Month 9
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Month 12
measure: Number of monocytes (CD14+, CD16+)
timeFrame: Month 18
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Day 1
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Day 8
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Day 22
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Day 23
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Day 36
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Day 50
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Month 3
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Month 6
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Month 9
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Month 12
measure: Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
timeFrame: Month 18
measure: TNF-a levels
timeFrame: Day 1
measure: TNF-a levels
timeFrame: Day 8
measure: TNF-a levels
timeFrame: Day 22
measure: TNF-a levels
timeFrame: Day 23
measure: TNF-a levels
timeFrame: Day 36
measure: TNF-a levels
timeFrame: Day 50
measure: TNF-a levels
timeFrame: Month 3
measure: TNF-a levels
timeFrame: Month 6
measure: TNF-a levels
timeFrame: Month 9
measure: TNF-a levels
timeFrame: Month 12
measure: TNF-a levels
timeFrame: Month 18
measure: CRP levels
timeFrame: Day 1
measure: CRP levels
timeFrame: Day 8
measure: CRP levels
timeFrame: Day 22
measure: CRP levels
timeFrame: Day 23
measure: CRP levels
timeFrame: Day 36
measure: CRP levels
timeFrame: Day 50
measure: CRP levels
timeFrame: Month 3
measure: CRP levels
timeFrame: Month 6
measure: CRP levels
timeFrame: Month 9
measure: CRP levels
timeFrame: Month 12
measure: CRP levels
timeFrame: Month 18
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Evangelos Terpos
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.