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

Neoplasms Clinical Trial

— UNICO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932863
• Other study ID #: 35UCS2021
• Status: Recruiting
• Start date: March 15, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: June 2021
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: Marco Musso, PhD
• Phone: 00390105634521
• Email: marco.musso[@]galliera.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Treatment-Related
• Neoplasms
• Neoplasms, Second Primary

Intervention

Biological:
• BNT162b2 mRNA Covid-19 Vaccine
Two injections, 21 days apart, of the BNT162b2 vaccine 30 µg per dose in the deltoid muscle.

Locations

Country	Name	City	State
Italy	E.O. Ospedali Galliera	Genova

Sponsors (2)

Lead Sponsor	Collaborator
Ente Ospedaliero Ospedali Galliera	University of Genoa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Safety assessment	Number and Grade of Adverse Events (AE) related to vaccine in patients undergoing anti-cancer treatment.	up to 24 months
Secondary	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
Secondary	Antibody titer correlations with cancer	To correlate the antibody titer with the type of cancer and cancer staging/grading	up to 24 months
Secondary	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
Secondary	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
Secondary	Immune cell activation	Correlate soluble factors of inflammatory response with blood cell count and inflammatory and pro-thrombotic biomarkers	up to 24 months
Secondary	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