Condition or disease | Intervention/treatment |
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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 |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Group/Cohort | Intervention/treatment |
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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.
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Biological: BNT162b2 mRNA Covid-19 Vaccine
Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marco Musso, PhD | 00390105634521 | marco.musso@galliera.it | |
Contact: Nicoletta Provinciali, MD | 00390105634212 | n.provinciali@galliera.it |
Italy | |
E.O. Ospedali Galliera | Recruiting |
Genova, Italy, 16128 | |
Contact: Andrea De Censi, MD 00390105634501 andrea.decensi@galliera.it | |
Contact: Nicoletta Provinciali, MD 00390105634212 n.provinciali@galliera.it |
Principal Investigator: | Andrea De Censi, MD | E.O. Ospedali Galliera |
Tracking Information | |||||||||||||||
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First Submitted Date | June 14, 2021 | ||||||||||||||
First Posted Date | June 21, 2021 | ||||||||||||||
Last Update Posted Date | June 21, 2021 | ||||||||||||||
Actual Study Start Date | March 15, 2021 | ||||||||||||||
Estimated Primary Completion Date | March 15, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||||||||
Change History | No Changes Posted | ||||||||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title | BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment | ||||||||||||||
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 | ||||||||||||||
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. |
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Study Type | Observational | ||||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||||||||
Biospecimen | Retention: Samples With DNA Description:
Lymphocytes B and T cells for antigen-specific immune response studies; serum for cytokine panel
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Sampling Method | Non-Probability Sample | ||||||||||||||
Study Population | Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics | ||||||||||||||
Condition |
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Intervention | Biological: BNT162b2 mRNA Covid-19 Vaccine
Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.
|
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Study Groups/Cohorts | 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.
Intervention: Biological: BNT162b2 mRNA Covid-19 Vaccine
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Publications * | 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 Oct 11;159:105-112. doi: 10.1016/j.ejca.2021.09.030. [Epub ahead of print] | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status | Recruiting | ||||||||||||||
Estimated Enrollment |
300 | ||||||||||||||
Original Estimated Enrollment | Same as current | ||||||||||||||
Estimated Study Completion Date | March 15, 2023 | ||||||||||||||
Estimated Primary Completion Date | March 15, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||
Contacts |
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Listed Location Countries | Italy | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number | NCT04932863 | ||||||||||||||
Other Study ID Numbers | 35UCS2021 | ||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Andrea DeCensi, Ente Ospedaliero Ospedali Galliera | ||||||||||||||
Study Sponsor | Ente Ospedaliero Ospedali Galliera | ||||||||||||||
Collaborators | University of Genoa | ||||||||||||||
Investigators |
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PRS Account | Ente Ospedaliero Ospedali Galliera | ||||||||||||||
Verification Date | June 2021 |