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

Ente Ospedaliero Ospedali Galliera

Status: Completed

Conditions: Neoplasms; Cancer, Treatment-Related

Treatments: Biological: BNT162b2 mRNA Covid-19 Vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04932863

35UCS2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Subjects with cancer of any type and stage under active or prior medical treatment

Description:

BNT162b2 mRNA Covid-19 Vaccine as two injections, 21 days apart, of 30 μg per dose in the deltoid muscle.

Treatment:

Biological: BNT162b2 mRNA Covid-19 Vaccine