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

Neoplasms Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04932863
• Study type: Observational
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: Marco Musso, PhD
• Phone: 00390105634521
• Email: marco.musso@galliera.it
• Status: Recruiting
• Start date: March 15, 2021
• Completion date: March 15, 2023