NeoplasmsUNICONCT04932863
BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment
An observational study of Neoplasms and Cancer, Treatment-Related, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Cancer, Treatment-Related
- What is being tested?
- BNT162b2 mRNA Covid-19 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2021to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics
Who may be able to join
- 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
Who cannot join
- Subjects who are not eligible for "Pfizer-BioNTech COVID-19" vaccine administration
- Inability and/or unwillingness to sign written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- BNT162b2 mRNA Covid-19 Vaccine
- Keywords
- neoplasms, COVID-19, Pfizer SARS- CoV-2 RNA vaccine
- Medical subject headings
- Neoplasms, Neoplasms, Second Primary, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 mRNA Covid-19 VaccineBiological
Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: BNT162b2 mRNA Covid-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 12 months
Comparison of the immune response in treated and untreated patients
Identification of predictive factors for antibody response in treated versus untreated patients
Measured: up to 12 months
Secondary outcomes (7)
Safety assessment
Number and Grade of Adverse Events (AE) related to vaccine in patients undergoing anti-cancer treatment.
Measured: up to 24 months
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.
Measured: up to 24 months
Antibody titer correlations with cancer
To correlate the antibody titer with the type of cancer and cancer staging/grading
Measured: up to 24 months
Antibody titer correlations with patients
To correlate the antibody titer with host characteristics, including psychological variables such as distress and anxiety or depression.
Measured: up to 24 months
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
Measured: up to 24 months
Immune cell activation
Correlate soluble factors of inflammatory response with blood cell count and inflammatory and pro-thrombotic biomarkers
Measured: up to 24 months
Immunological memory
Comparing lymphocyte activation in cancer patients responding to the vaccine versus those non responding (S1/S2 IgG <15 AU/mL)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start15 Mar 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Ospedali Galliera
- Sponsor type
- University, hospital or other
- Collaborators
- Universita degli Studi di Genova
- Responsible party
- Principal investigator, Andrea DeCensi, Ente Ospedaliero Ospedali Galliera
- Investigators
- Andrea De Censi, MD, Principal investigator, E.O. Ospedali Galliera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932863
- Sponsor's protocol ID
- 35UCS2021
- Acronym
- UNICO
- Status last verified
- Aug 2025
- First submitted
- 14 Jun 2021
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the primary publication of the trial will be shared (text, tables, figures, and appendices), after deidentification
Publications
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.
PubMed 34742157
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04932863
- Acronym / sponsor ID
- UNICO / 35UCS2021
- Conditions
- Neoplasms, Cancer, Treatment-Related
- Keywords
- neoplasms, COVID-19, Pfizer SARS- CoV-2 RNA vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ente Ospedaliero Ospedali GallieraUniversity, hospital or other
- Collaborators
- Universita degli Studi di Genova
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with cancer of any type and stage under active or prior medical treatment | – | Biological: BNT162b2 mRNA Covid-19 VaccineBNT162b2 mRNA Covid-19 Vaccine as two injections, 21 days apart, of 30 μg per dose in the deltoid muscle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects who are not eligible for "Pfizer-BioNTech COVID-19" vaccine administration
- Inability and/or unwillingness to sign written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT162b2 mRNA Covid-19 VaccineTwo injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle. | Biological | Subjects with cancer of any type and stage under active or prior medical treatment |
Primary outcome
Antibody titer reactogenicity assessment
Time frame: up to 12 months
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
Comparison of the immune response in treated and untreated patients
Time frame: up to 12 months
Identification of predictive factors for antibody response in treated versus untreated patients
7 secondary outcomes
Safety assessment
Time frame: up to 24 months
Antibody titer correlations with therapy
Time frame: up to 24 months
Antibody titer correlations with cancer
Time frame: up to 24 months
Antibody titer correlations with patients
Time frame: up to 24 months
Inflammatory response evaluation
Time frame: up to 24 months
Immune cell activation
Time frame: up to 24 months
Immunological memory
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 34742157Buttiron 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the primary publication of the trial will be shared (text, tables, figures, and appendices), after deidentification
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea De Censi, MD principal investigator
E.O. Ospedali Galliera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Cancer, Treatment-Related, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titer reactogenicity assessment (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.