Clinical trial · Observational
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.
NCT06334744CI-TRIAL-00075540completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncologic Complications | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determination of the change in neutralizing antibodies against SARS-CoV-2 (CLIA method) towards VOCs before the third dose of COVID-19 vaccine and 21 days after the same.
- timeFrame
- 3 weeks
- description
- The immune response to viral variants will be evaluated by neutralization tests. In detail, previously titrated and characterized viral isolates representative of the alpha, beta, gamma and delta variants will be used. Any new variants relevant from a clinical and epidemiological point of view will subsequently be taken into consideration. A positive neutralizing titer is considered to be a titer equal to or greater than 1:10
Secondary outcomes (4)
- measure
- Evaluation of the kinetics of neutralizing antibodies and anti-SARS-CoV-2 IgG titer (CLIA method) up to 52 weeks after the third dose of COVID-19 vaccine
- timeFrame
- 0, 3, 26, 52 weeks
- description
- The difference in antibody titers from time 0, at 3 and 26 weeks, up to week 52
- measure
- Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged 18 years or older, regardless of gender; 2. Life expectancy (estimated by the treating doctor) ≥ 6 months; 3. Histological diagnosis confirmed solid neoplasm; 4. Under active treatment 5. Previous two doses of Pfizer anti-SARS-CoV-2 vaccine received (will be considered also patients who have completed the vaccination cycle with other mRNA vaccines - Modern-) 6. All participants subscribed and signed the informed consent form first of enlistment 7. Patients with a positive history of a previous diagnosis are also enrolled laboratory confirmed COVID-19 8. ECOG 0-2 Exclusion Criteria: 1\. Inability to sign informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.