BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment (UNICO)
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|ClinicalTrials.gov Identifier: NCT04932863|
Recruitment Status : Recruiting
First Posted : June 21, 2021
Last Update Posted : June 21, 2021
|Condition or disease||Intervention/treatment|
|Neoplasms Cancer, Treatment-Related||Biological: BNT162b2 mRNA Covid-19 Vaccine|
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|
|Estimated Enrollment :||300 participants|
|Official Title:||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|
|Actual Study Start Date :||March 15, 2021|
|Estimated Primary Completion Date :||March 15, 2022|
|Estimated Study Completion Date :||March 15, 2023|
Subjects with cancer of any type and stage under active or prior medical treatment
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
Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.
- Antibody titer reactogenicity assessment [ Time Frame: 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 [ Time Frame: up to 12 months ]Identification of predictive factors for antibody response in treated versus untreated patients
- Safety assessment [ Time Frame: up to 24 months ]Number and Grade of Adverse Events (AE) related to vaccine in patients undergoing anti-cancer treatment.
- Antibody titer correlations with therapy [ Time Frame: 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.
- Antibody titer correlations with cancer [ Time Frame: up to 24 months ]To correlate the antibody titer with the type of cancer and cancer staging/grading
- Antibody titer correlations with patients [ Time Frame: up to 24 months ]To correlate the antibody titer with host characteristics, including psychological variables such as distress and anxiety or depression.
- Inflammatory response evaluation [ Time Frame: 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
- Immune cell activation [ Time Frame: up to 24 months ]Correlate soluble factors of inflammatory response with blood cell count and inflammatory and pro-thrombotic biomarkers
- Immunological memory [ Time Frame: up to 24 months ]Comparing lymphocyte activation in cancer patients responding to the vaccine versus those non responding (S1/S2 IgG <15 AU/mL)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04932863
|Contact: Marco Musso, PhDemail@example.com|
|Contact: Nicoletta Provinciali, MDfirstname.lastname@example.org|
|Principal Investigator:||Andrea De Censi, MD||E.O. Ospedali Galliera|