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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Cancer, Treatment-Related
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Marco Musso, PhD; Phone Number: 00390105634521; Email: marco.musso@galliera.it
• Study Contact Backup: Name: Nicoletta Provinciali, MD; Phone Number: 00390105634212; Email: n.provinciali@galliera.it

Study Locations

• Italy
  • Genova, Italy, 16128
    • Recruiting
    • E.O. Ospedali Galliera
    • Contact: Nicoletta Provinciali, MD; Phone Number: 00390105634212; Email: n.provinciali@galliera.it
    • Contact: Andrea De Censi, MD; Phone Number: 00390105634501; Email: andrea.decensi@galliera.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Ospedali Galliera
• Collaborators: University of Genoa
• Investigators: Principal Investigator: Andrea De Censi, MD, E.O. Ospedali Galliera

Publications and helpful links

General 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 Dec;159:105-112. doi: 10.1016/j.ejca.2021.09.030. Epub 2021 Oct 11.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Anticipated): March 15, 2022
• Study Completion (Anticipated): March 15, 2023

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; neoplasms; Pfizer SARS- CoV-2 RNA vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Neoplasms, Second Primary
• Other Study ID Numbers: 35UCS2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Time Frame: Data will be shared 3 months following the publication of the article and they will remain available for 36 months.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No