Prospective Biological Study to Evaluate the Persistence of COVID-19 Vaccine and Other Vaccines'-Induced Immune Responses in Follicular Lymphoma Patients Undergoing Frontline Induction Immuno-chemotherapy and Anti-CD20 Maintenance
FIL_FollVax22
1 other identifier
observational
56
1 country
14
Brief Summary
This is a prospective biological study evaluating the persistence of COVID-19 vaccine and other vaccines' (zoster, diphtheria and tetanus)-induced immunity in a subgroup patient affected by Follicular Lymphoma requiring treatment undergoing frontline induction immuno-chemotherapy and anti-CD20 maintenance within the prospective FIL\_FOLL19 study (NCT05058404). Blood samples from patients will be collected before and at planned timepoints during treatment to evaluate humoral and cellular immunity against SARS-COV-2, VZV, tetanus and diphtheria and T-cell markers characterization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2024
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedStudy Start
First participant enrolled
May 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
June 29, 2025
June 1, 2025
3 years
October 3, 2023
June 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of patients with persistence of cell-mediated immunity induced by COVID-19 approved vaccines (at least three doses) after standard induction immuno-chemotherapy.
Proportion of patients with laboratory parameters of vaccine-induced cellular immunity against SARS-CoV-2 (by ELISpot assay) at EOI (after induction immuno-chemotherapy) vs proportion at baseline
At the end of induction therapy (EOI) - About 8 months from treatment start
Secondary Outcomes (7)
Rate of patients with persistence of cell-mediated immunity induced by COVID-19 approved vaccines (at least three doses) during anti-CD20 mAbs maintenance
At +12 months of maintenance - About 20 months from treatment start
Rate of patients with persistence of humoral immunity induced by COVID-19 approved vaccines (at least three doses) after standard induction immuno-chemotherapy and during maintenance.
At the end of induction therapy (EOI) and at +12 months of maintenance - About 8 months and 20 months from treatment start respectively
Rate of patients (with a detectable serologic response at study entry) with persistence of humoral and cellular immunity induced by adjuvanted recombinant zoster vaccine after standard induction immuno-chemotherapy and during maintenance
At the end of induction therapy (EOI) and at +12 months of maintenance - About 8 months and 20 months from treatment start respectively
Rate of patients (with a detectable serologic response at study entry) with persistence of humoral immunity induced by childhood vaccines (diphtheria and tetanus) after standard induction immuno-chemotherapy and during maintenance
At the end of induction therapy (EOI) and at +12 months of maintenance - About 8 months and 20 months from treatment start respectively
Rate of COVID-19 infection events and severity in vaccinated patients and correlation with humoral and/or cellular immunity with eventual tixagevimab/cilgavimab or other MAb prophylaxis and with dominant SARS-CoV-2 variant/subvariant at time of infection
From baseline (before therapy) up to 20 months from treatment start (+12 months of maintenance)
- +2 more secondary outcomes
Study Arms (1)
Patients enrolled
Patient affected by advanced Follicular Lymphoma undergoing front-line immunochemotherapy and antiCD-20 maintenance in the FIL\_FOLL19 trial
Interventions
Evaluation of cellular immunity vs SARS-CoV-2 by ELISpot assay
Evaluation of Humoral immunity vs SARS-CoV-2 by ELISA assay (IgG anti-RBD and anti-N)
Evaluation of cellular immunity vs VZV by Enzyme-Linked immunoSPOT (ELISPOT) assay
Evaluation of humoral immunity vs VZV by ELISA (VZV gE-binding IgG)
Evaluation of diphtheria toxin-binding IgG by ELISA assay
Evaluation of tetanus toxoid-binding IgG by ELISA assay
Characterization of T-cell populations and markers by flow cytometry
Eligibility Criteria
Patients affected by Follicular Lymphoma undergoing frontline induction immuno-chemotherapy and anti-CD20 maintenance within the prospective FIL\_FOLL19 study
You may qualify if:
- Enrolment in FIL\_FOLL19 study
- Previous vaccination for COVID-19 (at least 3 doses)
- Availability of informations about COVID-19 and other vaccines previously administered (vaccination records)
- Willingness to comply with blood collection timepoints required for vaccination immunity evaluation
- Signature of specific informed consent form
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, AV, 83100, Italy
A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia
Alessandria, IT, Italy
Nuovo Ospedale degli Infermi, SSD Ematologia
Biella, IT, Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, IT, Italy
Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - Ematologia
Milan, IT, Italy
A.O.U. Maggiore della Carità di Novara - S.C.D.U. Ematologia
Novara, IT, Italy
IRCCS Policlinico San Matteo - Divisione di Ematologia
Pavia, IT, Italy
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Piacenza, IT, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
Torino, IT, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino, IT, Italy
ASST Spedali Civili - S.C. Ematologia
Brescia, Italy
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia, Italy
A.O.U. Senese - U.O.C. Ematologia
Siena, Italy
Biospecimen
Peripheral blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Merli, MD
U.O.C Ematologia, Ospedale di Circolo, Varese
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 6, 2023
Study Start
May 7, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
June 29, 2025
Record last verified: 2025-06