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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04932863
Other study ID # 35UCS2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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