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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
Sponsor: Fondazione Italiana Linfomi - ETS
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
56
Start Date
2024-05-07
Completion Date
2027-05
Last Updated
2025-06-29
Healthy Volunteers
No
Conditions
Interventions
Cellular immunity vs SARS-CoV-2
Evaluation of cellular immunity vs SARS-CoV-2 by ELISpot assay
Humoral immunity vs SARS-CoV-2
Evaluation of Humoral immunity vs SARS-CoV-2 by ELISA assay (IgG anti-RBD and anti-N)
Cellular immunity vs Varicella Zoster Virus
Evaluation of cellular immunity vs VZV by Enzyme-Linked immunoSPOT (ELISPOT) assay
Humoral immunity vs Varicella Zoster Virus
Evaluation of humoral immunity vs VZV by ELISA (VZV gE-binding IgG)
Diphtheria toxin-binding IgG
Evaluation of diphtheria toxin-binding IgG by ELISA assay
Tetanus toxoid-binding IgG
Evaluation of tetanus toxoid-binding IgG by ELISA assay
T-cell populations and markers characterization
Characterization of T-cell populations and markers by flow cytometry
Locations (14)
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, AV, 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