Cancer, Treatment-Related, Neoplasms
Conditions
Keywords
neoplasms, COVID-19, Pfizer SARS- CoV-2 RNA vaccine
Brief summary
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
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.
Interventions
BIOLOGICALBNT162b2 mRNA Covid-19 Vaccine
Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.
Sponsors
Universita degli Studi di Genova
Ente Ospedaliero Ospedali Galliera
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody titer reactogenicity assessment | up to 12 months | 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 |
| Comparison of the immune response in treated and untreated patients | up to 12 months | Identification of predictive factors for antibody response in treated versus untreated patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody titer correlations with cancer | up to 24 months | To correlate the antibody titer with the type of cancer and cancer staging/grading |
| Antibody titer correlations with patients | up to 24 months | To correlate the antibody titer with host characteristics, including psychological variables such as distress and anxiety or depression. |
| Safety assessment | up to 24 months | Number and Grade of Adverse Events (AE) related to vaccine in patients undergoing anti-cancer treatment. |
| Immune cell activation | up to 24 months | Correlate soluble factors of inflammatory response with blood cell count and inflammatory and pro-thrombotic biomarkers |
| Immunological memory | up to 24 months | Comparing lymphocyte activation in cancer patients responding to the vaccine versus those non responding (S1/S2 IgG \<15 AU/mL) |
| Inflammatory response evaluation | up to 24 months | Dosage of soluble factors (including pro-inflammatory cytokines, Cytokine Multiplex Assay Kits) in responders and non responders to Pfizer SARS-CoV-2 RNA vaccine |
| Antibody titer correlations with therapy | up to 24 months | 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. |
Countries
Italy
Outcome results
None listed