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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
Sponsor:
Collaborator:
University of Genoa
Information provided by (Responsible Party):
Andrea DeCensi, Ente Ospedaliero Ospedali Galliera

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.

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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

Resource links provided by the National Library of Medicine


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.




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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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
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Principal Investigator: Andrea De Censi, MD E.O. Ospedali Galliera
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Responsible Party: Andrea DeCensi, Director of Medical Oncology, Ente Ospedaliero Ospedali Galliera
ClinicalTrials.gov Identifier: NCT04932863    
Other Study ID Numbers: 35UCS2021
First Posted: June 21, 2021    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea DeCensi, Ente Ospedaliero Ospedali Galliera:
neoplasms
COVID-19
Pfizer SARS- CoV-2 RNA vaccine
Additional relevant MeSH terms:
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Neoplasms, Second Primary
Neoplasms