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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2023-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immunogenicity of Prime-boost Vaccination of SARS-CoV-2 in Patients With Cancer

NCT05273541

Patients With Cancer Vaccine Reaction COVID-19

UNKNOWN PHASE1/PHASE2

Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active.

NCT06334744

Oncologic Complications

COMPLETED

Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer

NCT05018078

Patients With Cancers COVID-19 Vaccine

UNKNOWN NA

Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma

NCT06932861

Rhabdomyosarcoma

NOT_YET_RECRUITING EARLY_PHASE1

A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors

NCT00419328

Advanced Solid Tumors

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms Cancer, Treatment-Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

BNT162b2 mRNA Covid-19 Vaccine

Intervention Type BIOLOGICAL

Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BNT162b2 mRNA Covid-19 Vaccine

Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No