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出境医 / 临床实验 / BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment (UNICO)

BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment (UNICO)

Study Description
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.

Condition or disease Intervention/treatment
Neoplasms Cancer, Treatment-Related Biological: BNT162b2 mRNA Covid-19 Vaccine

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.

Study Design
Layout table for study information
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
Arms and Interventions
Group/Cohort Intervention/treatment
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.

Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Safety assessment [ Time Frame: up to 24 months ]
    Number and Grade of Adverse Events (AE) related to vaccine in patients undergoing anti-cancer treatment.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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
Lymphocytes B and T cells for antigen-specific immune response studies; serum for cytokine panel

Eligibility Criteria
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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
Study Population
Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics
Criteria

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
Contacts and Locations

Contacts
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Contact: Marco Musso, PhD 00390105634521 marco.musso@galliera.it
Contact: Nicoletta Provinciali, MD 00390105634212 n.provinciali@galliera.it

Locations
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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   
Sponsors and Collaborators
Ente Ospedaliero Ospedali Galliera
University of Genoa
Investigators
Layout table for investigator information
Principal Investigator: Andrea De Censi, MD E.O. Ospedali Galliera
Tracking Information
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
 (submitted: June 18, 2021)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 18, 2021)
  • 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)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
Sampling Method Non-Probability Sample
Study Population Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics
Condition
  • Neoplasms
  • Cancer, Treatment-Related
Intervention Biological: BNT162b2 mRNA Covid-19 Vaccine
Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.
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
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.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 18, 2021)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Marco Musso, PhD 00390105634521 marco.musso@galliera.it
Contact: Nicoletta Provinciali, MD 00390105634212 n.provinciali@galliera.it
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
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
Responsible Party Andrea DeCensi, Ente Ospedaliero Ospedali Galliera
Study Sponsor Ente Ospedaliero Ospedali Galliera
Collaborators University of Genoa
Investigators
Principal Investigator: Andrea De Censi, MD E.O. Ospedali Galliera
PRS Account Ente Ospedaliero Ospedali Galliera
Verification Date June 2021