Clinical trial · Observational
BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Treatment-Related | Malignant Neoplasm | ALIAS | 0.85 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BNT162b2 mRNA Covid-19 Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects with cancer of any type and stage under active or prior medical treatment
- description
- BNT162b2 mRNA Covid-19 Vaccine as two injections, 21 days apart, of 30 μg per dose in the deltoid muscle.
- interventionNames
- Biological: BNT162b2 mRNA Covid-19 Vaccine
Primary outcomes (2)
- measure
- Antibody titer reactogenicity assessment
- timeFrame
- up to 12 months
- description
- 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
- measure
- Comparison of the immune response in treated and untreated patients
- timeFrame
- up to 12 months
- description
- Identification of predictive factors for antibody response in treated versus untreated patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDButtiron 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 34742157