An observational study in Neoplasms and Cancer, Treatment-Related, sponsored by Ente Ospedaliero Ospedali Galliera. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Ente Ospedaliero Ospedali Galliera · Observational
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.
96 studies on the registry are indexed under Neoplasms, Second Primary; 35 are open to participants now.
This study's enrollment of 300 is below the median of 750 across 45 observational studies indexed under Neoplasms, Second Primary.
Browse Neoplasms, Second Primary studies →Ente Ospedaliero Ospedali Galliera is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
Compared within Neoplasms, Second Primary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Plan to share: Yes — Individual participant data that underlie the results reported in the primary publication of the trial will be shared (text, tables, figures, and appendices), after deidentification
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be shared 3 months following the publication of the article and they will remain available for 36 months.
Access criteria: the investigators who would like to use the data have to prepare a proposal that should be send to the Principal investigator (andrea.decensi@galliera.it).To gain access, data requestors will need to sign a data access agreement
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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