NCT04932863

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

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: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Ente Ospedaliero Ospedali Galliera · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms
• Cancer, Treatment-Related

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2 mRNA Covid-19 Vaccine	Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-03-15
• Completion: 2023-03-15
• First posted: 2021-06-21
• Last updated: 2025-08-08

Locations

1 site across 1 country: Italy