Clinical trial NCT04932863: BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasms
Cancer, Treatment-Related
Keywords: neoplasms
COVID-19
Pfizer SARS- CoV-2 RNA vaccine
Lead sponsor: Ente Ospedaliero Ospedali Galliera
Sponsor class: OTHER
Collaborators: name: Universita degli Studi di Genova
First posted: 2021-06-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Antibody titer reactogenicity assessment
timeFrame: up to 12 months
measure: Comparison of the immune response in treated and untreated patients
timeFrame: up to 12 months
Secondary outcomes:
measure: Safety assessment
timeFrame: up to 24 months
measure: Antibody titer correlations with therapy
timeFrame: up to 24 months
measure: Antibody titer correlations with cancer
timeFrame: up to 24 months
measure: Antibody titer correlations with patients
timeFrame: up to 24 months
measure: Inflammatory response evaluation
timeFrame: up to 24 months
measure: Immune cell activation
timeFrame: up to 24 months
measure: Immunological memory
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Genova
country: Italy
facility: E.O. Ospedali Galliera
Study officials:
affiliation: E.O. Ospedali Galliera
name: Andrea De Censi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buttiron Webber T, Provinciali N, Musso M, Ugolini M, Boitano M, Clavarezza M, D'Amico M, Defferrari C, Gozza A, Briata IM, Magnani M, Paciolla F, Menghini N, Marcenaro E, De Palma R, Sacchi N, Innocenti L, Siri G, D'Ecclesiis O, Cevasco I, Gandini S, DeCensi A. Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment. Eur J Cancer. 2021 Dec;159:105-112. doi: 10.1016/j.ejca.2021.09.030. Epub 2021 Oct 11.