PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; (and multiple other pneumococcal polysaccharide serotypes as listed in product record) for Lymphoma | Diffuse large B-cell lymphoma | Follicular lymphoma

Inclusion criteria

• {"criterion_text":"- Patient ≥ 18 year-old\n- AND medical follow-up in hematology unit\n- AND had received a first course of chemotherapy for diffuse large B cell lymphoma or for follicular lymphoma\n- Life expectancy > 6 months\n- Negative pregnancy test\n- Having signed the consent form\n- Having an health insurance\n- Free subject, without guardianship, tutorship or subordination"}

Exclusion criteria

• {"criterion_text":"- Receiving monoclonal antibodies or biotherapies altering the immune response, other than anti-CD20 antibodies in the chemotherapy protocol\n- Patient who already received chemotherapy for malignancy in the previous 2 years before the inclusion\n- Major blood clotting disorders preventing intramuscular injection.\n- Medical history of anaphylactic reaction to vaccination\n- Known allergy to one of the vaccine components\n- Involvement to another vaccine research\n- Protected person\n- Pregnant women or women of childbearing age without appropriate contraceptive measures.\n- Perfusion of polyvalent immunoglobulins during follow-up.\n- Participants with hypersensitivity to aluminum phosphate, phenol or CRM197 protein, protein derived from Corynebacterium diphtheria\n- Uncontrolled bacterial, viral or fungal infection less than 7 days\n- Previous vaccination with PCV13 or PPV23 (unless PCV13 was administered in childhood. The last injection must be performed at least five years ago)\n- Preexisting condition that altered the immune response: splenectomy, HIV, primary or secondary immune deficiency, nephrotic syndrome, sickle cell anemia, autoimmune disorder, solid organ transplantation, immunosuppressive drugs or biotherapy not included in the chemotherapy"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients responding to the combined vaccination strategy (PCV13 + PPV23) assessed 4 weeks after PPV23 vaccination compared with the PREVENAR20 single injection vaccination strategy assessed 3 months post-injection according to the level of anti-pneumococcal IgG","definition_or_measurement_approach":"Response defined by serotype-specific anti-pneumococcal IgG per WHO ELISA criteria: ELISA serotype-specific IgG ≥ 1.3 µg/mL AND a two-fold increase from baseline AND opsonophagocytic activity (OPA) ≥ 1/8 AND a four-fold increase in functional antibody titer compared with baseline (assessment timepoints: 4 weeks post-PPV23 vs 3 months post-PREVENAR20)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients having an ELISA serotype-specific IgG titer ≥ 1.3μg/mL (WHO threshold) and a two-fold increase of this IgG titer compared to baseline at 4 weeks after the PCV13 injection or PREVENAR20","definition_or_measurement_approach":"ELISA serotype-specific IgG titer ≥ 1.3 µg/mL (WHO threshold) AND ≥2-fold increase from baseline measured at 4 weeks post-injection (PCV13 or PREVENAR20)."}
• {"endpoint_text":"- Proportion of patients having a sustainable response to vaccination defined by an ELISA serotype-specific IgG titer ≥ 1.3μg/mL and a two-fold increase of this IgG titer compared to baseline between 3-6 months after the PPV23 injection or 5-8 months after PREVENAR20 injection","definition_or_measurement_approach":"Sustained response: ELISA serotype-specific IgG ≥ 1.3 µg/mL AND ≥2-fold increase from baseline measured at 3-6 months post-PPV23 or 5-8 months post-PREVENAR20."}
• {"endpoint_text":"- Proportion of patients having a sustainable response to vaccination defined by the same criteria as the primary outcome and measured between 9-12 months after the PPV23 injection or 11-14 months after PREVENAR20 injection","definition_or_measurement_approach":"Sustained response per primary outcome definition measured at 9-12 months after PPV23 or 11-14 months after PREVENAR20."}
• {"endpoint_text":"- Proportion of responding patients having titers of IgG, IgG2, IgM, and IgA rising significantly at 4 weeks after PCV13 injection, and 4 weeks, 3- 6 months and 9-12 months after PPV23 injectionor at 4 weeks, 3 months, 5-8 months, 11-14 months after PREVENAR20 injection.","definition_or_measurement_approach":"Measurement of anti-pneumococcal IgA, IgM, IgG and IgG2 by global ELISA at specified timepoints (4 weeks after PCV13; 4 weeks, 3-6 months, 9-12 months after PPV23; 4 weeks, 3 months, 5-8 months, 11-14 months after PREVENAR20) to assess significant rises in titers among responders."}
• {"endpoint_text":"- To determine predictive factors for non-response to vaccination at 4weeks, and 6-12 months after PPV23 injection/11-14 months PREVENAR 20 such as age, hematological malignancy, immune status, chemotherapy,.....","definition_or_measurement_approach":"Exploratory analysis of predictors (age, hematological malignancy subtype, baseline immune status including plasma gammaglobulin levels, type of chemotherapy, associated immunotherapy) for non-response at 4 weeks and at later follow-up timepoints (6-12 months post-PPV23 / 11-14 months post-PREVENAR20)."}
• {"endpoint_text":"- Number of patients having local or general reactions to vaccination and number of invasive pneumococcal infections with a documented serotype considered as vaccination failure","definition_or_measurement_approach":"Safety/tolerability: count of local/systemic adverse reactions post-vaccination; clinical endpoint: number of invasive pneumococcal infections with documented serotype during study considered vaccination failures."}
• {"endpoint_text":"- To assess the concordance between the reference immuno-monitoring dosage (WHO ELISA) and another kit of dosage (Vacczyme® Binding Site®).","definition_or_measurement_approach":"Analytical concordance assessment between WHO ELISA reference assay and Vacczyme® Binding Site® kit for measurement of anti-pneumococcal antibodies."}

France

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

23-10-2025

Processing Time Days

377

Number Of Sites

7

Number Of Participants

160

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Poitiers

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France