NCT04932863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

June 14, 2021

Last Update Submit

August 5, 2025

Conditions

NeoplasmsCancer, Treatment-Related

Keywords

neoplasmsCOVID-19Pfizer SARS- CoV-2 RNA vaccine

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • Safety assessment

    up to 24 months

  • Antibody titer correlations with therapy

    up to 24 months

  • Antibody titer correlations with cancer

    up to 24 months

  • Antibody titer correlations with patients

    up to 24 months

  • Inflammatory response evaluation

    up to 24 months

  • +2 more secondary outcomes

Study Arms (1)

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.

Biological: BNT162b2 mRNA Covid-19 Vaccine

Interventions

BNT162b2 mRNA Covid-19 VaccineBIOLOGICAL

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients on current or prior active treatment or ultravulnerable according to clinical characteristics

You may qualify if:

  • 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

You may not qualify if:

  • Subjects who are not eligible for "Pfizer-BioNTech COVID-19" vaccine administration
  • Inability and/or unwillingness to sign written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E.O. Ospedali Galliera

Genova, Italy, 16128, Italy

Location

Related Publications (1)

  • 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.

    PMID: 34742157DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Lymphocytes B and T cells for antigen-specific immune response studies; serum for cytokine panel

MeSH Terms

Conditions

NeoplasmsNeoplasms, Second PrimaryCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Andrea De Censi, MD

    E.O. Ospedali Galliera

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Medical Oncology

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 21, 2021

Study Start

March 15, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2023

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be shared 3 months following the publication of the article and they will remain available for 36 months.
Access Criteria
the investigators who would like to use the data have to prepare a proposal that should be send to the Principal investigator (andrea.decensi@galliera.it).To gain access, data requestors will need to sign a data access agreement

Locations

IT(1)