Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universita degli Studi di Genova | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 mRNA Covid-19 Vaccine | Biological | Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea De Censi, MD | E.O. Ospedali Galliera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E.O. Ospedali Galliera | Genova | Italy | 16128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34742157 | Derived | Buttiron Webber T, Provinciali N, Musso M, Ugolini M, Boitano M, Clavarezza M, D'Amico M, Defferrari C, Gozza A, Briata IM, Magnani M, Paciolla F, Menghini N, Marcenaro E, De Palma R, Sacchi N, Innocenti L, Siri G, D'Ecclesiis O, Cevasco I, Gandini S, DeCensi A. Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment. Eur J Cancer. 2021 Dec;159:105-112. doi: 10.1016/j.ejca.2021.09.030. Epub 2021 Oct 11. |
Not provided
Not provided
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
Data will be shared 3 months following the publication of the article and they will remain available for 36 months.
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
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D016609 | Neoplasms, Second Primary |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Lymphocytes B and T cells for antigen-specific immune response studies; serum for cytokine panel
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |