BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Observational Non Interventional Study of Reactogenicity and Safety of the BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment

Conditions
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Neoplasms, Cancer, Treatment-Related

Intervention / Treatment
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* Biological: BNT162b2 mRNA Covid-19 Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years On treatment for cancer during the last 6 months or being treated >6 months ago but being ultravulnerable About to receive Pfizer-BioNTech COVID-19 vaccine Lymphocyte count≥0.5x10^9/L Exclusion Criteria: Subjects who are not eligible for Pfizer-BioNTech COVID-19 vaccine administration Inability and/or unwillingness to sign written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with cancer of any type and stage under active or prior medical treatment<br>BNT162b2 mRNA Covid-19 Vaccine as two injections, 21 days apart, of 30 μg per dose in the deltoid muscle. | Biological: BNT162b2 mRNA Covid-19 Vaccine<br>* Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment | Number and Grade of Adverse Events (AE) related to vaccine in patients undergoing anti-cancer treatment. | 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. | up to 24 months | 
| Antibody titer correlations with cancer | To correlate the antibody titer with the type of cancer and cancer staging/grading | 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. | 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 | up to 24 months | 
| Immune cell activation | Correlate soluble factors of inflammatory response with blood cell count and inflammatory and pro-thrombotic biomarkers | 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) | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pfizer SARS- CoV-2 RNA vaccine, neoplasms, COVID-19