In this Italian observational study the antibody titer reactogenicity to Pfizer Severe Acute Respiratory Syndrome (SARS) - Coronavirus (CoV-2) RNA vaccine in cancer patients under active antitumor treatment will be evaluated at 21 and 42 days and after 6 months. Furthermore patients safety will be monitored. Factors affecting immunogenicity (or lack of), including cancer treatment, will be the primary aim of the study.
This is an observational non-interventional study in cancer patients. The study will evaluate the safety, tolerability and immunogenicity of Pfizer SARS-CoV-2 RNA vaccine against COronaVIrus Disease-19 (COVID-19) which will be delivered in the deltoid muscle in 2-dose (separated by 21 days). Blood will be collected in two 5 milliliters (mL) vacuettes for serum Immunoglobulin G (IgG) and Cytokine assessment, at baseline and after 21 days, immediately before the first and the second dose, respectively, then after 42 days from the first dose and finally after 6 months from the baseline. A panel of 22 cytokines (Biorad) will be measured at baseline and after 21 and 42 days in four groups consisting of: no responders (S1/S2 IgG\<15 Arbitrary Unit AU/ml at 42 days), slow responders (S1/S2 IgG\<15 AU/mL after 21 days and \>15 AU/mL after the second dose), fast responders (S1/S2 IgG\>15 AU/mL after the first 21 days) and immunized patients (S1/S2 IgG\>15 AU/mL at baseline). At baseline, at 42 days and 6 months questionnaires for psychological testing will be dispensed for completion to patients. After 42 days from the first dose, 15 mL of heparinized peripheral blood from both non-responders (S1/S2 IgG\<25 AU/mL) and responders will be used for isolation of different Cluster of Differentiation 4 (CD4+) and CD8+ T cell subpopulations and analysis of their capability to undergo activation/proliferation in response to specific SARS- CoV-2 derived peptides.
Study Type
OBSERVATIONAL
Enrollment
300
Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.
E.O. Ospedali Galliera
Genova, Italy, Italy
Antibody titer reactogenicity assessment
Serum IgG assessment at baseline, after 21 days, 42 days and after 6 months to Pfizer SARS- CoV-2 RNA vaccine in cancer patients under prior or current active antitumor treatment
Time frame: up to 12 months
Comparison of the immune response in treated and untreated patients
Identification of predictive factors for antibody response in treated versus untreated patients
Time frame: up to 12 months
Safety assessment
Number and Grade of Adverse Events (AE) related to vaccine in patients undergoing anti-cancer treatment.
Time frame: up to 24 months
Antibody titer correlations with therapy
To correlate the antibody titer with type and timing of therapy. Particular attention will be devoted to the effect in patients receiving checkpoint inhibitor immunotherapy.
Time frame: up to 24 months
Antibody titer correlations with cancer
To correlate the antibody titer with the type of cancer and cancer staging/grading
Time frame: up to 24 months
Antibody titer correlations with patients
To correlate the antibody titer with host characteristics, including psychological variables such as distress and anxiety or depression.
Time frame: up to 24 months
Inflammatory response evaluation
Dosage of soluble factors (including pro-inflammatory cytokines, Cytokine Multiplex Assay Kits) in responders and non responders to Pfizer SARS-CoV-2 RNA vaccine
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Time frame: up to 24 months
Immune cell activation
Correlate soluble factors of inflammatory response with blood cell count and inflammatory and pro-thrombotic biomarkers
Time frame: up to 24 months
Immunological memory
Comparing lymphocyte activation in cancer patients responding to the vaccine versus those non responding (S1/S2 IgG \<15 AU/mL)
Time frame: up to 24 months