Informations générales (source: ClinicalTrials.gov)
Immunogénicité de la Vaccination Anti-pneumococcique (PCV13+PPV23 Versus PREVENAR20) Dans le Lymphome Chez l'Adulte
Interventional
Phase 4
Poitiers University Hospital (Voir sur ClinicalTrials)
septembre 2021
novembre 2027
11 septembre 2025
The French Public Health Council recommended pneumococcal vaccination combined strategy
for all immunocompromised patients in 2012. This strategy consisted in conjugated
13-valent pneumococcal (PCV13) injection followed 2 months later by polysaccharide
23-valent (PPV23) vaccine injection. In 2024, Health authorities changed guidelines to
recommend one injection of PREVENAR20 instead of the 2-vaccine scheme general
practitioners are usually in charge of this vaccination. Conjugated pneumococcal vaccine
enhances the immunogenicity of the polysaccharide vaccine. Acute leukemia and lymphoma
are treated with multiple courses of chemotherapy, impairing the immune system and
potentially the response to vaccination. These patients are more at risk for developing
pneumococcal invasive diseases than the general population. However, efficacy of
pneumococcal vaccination is poorly documented in this setting. We assume that 65% of the
patients are non-responders to double compared to 45% for PCV20PREVENAR20 vaccination,
according to their anti-pneumococcal immunoglobulin G (Ig) titers and the
opsonophagocytic activity (OPA). To assess the immunogenicity of the pneumococcal
vaccination combined strategy in adult population of acute leukemia and lymphoma, we will
measure anti-pneumococcal serotype-specific IgG titers and OPA at different time-points
after completion of the combined vaccine strategy. The primary objective is to assess the
immunogenicity of pneumococcal vaccination combined strategy at 3 months after the PCV13
injection (corresponding to 1 month after the end of the combined strategy in cohort A)
using Ig G titers and OPA, compared to 3 months post PREVENAR20 (cohort B). At different
time points (day 0, 4 weeks post PCV13, and 4 weeks, 3-6 months and 9-12 months post
PPV23 and in day 0, 4 weeks post PREVENAR20 and 3 months, 5-8 months and 11-14 months
post PREVENAR20, the immunological response to vaccination will be monitored using
specific-serotype IgG titers, OPA, and total anti-pneumococcal Ig. We will determine
predictive factors of non-response to vaccination by comparing demographic data,
biological data and treatment received lymphoma patients. The tolerance and safety of the
vaccination strategy will also be assessed in this specific hematological population.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Ch Perigueux - Périgueux - France | Claire CALMETTES, Dr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Angers - Angers - France | Mathilde HUNAULT, Pr | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Bordeaux - France | François-Xavier GROS, Dr | Contact (sur clinicalTrials) | |||
| CHU Limoges - Limoges - France | Arnaud JACCARD, Pr | Contact (sur clinicalTrials) | |||
| Chu Nantes - Nantes - France | Pierre PETERLIN, Dr | Contact (sur clinicalTrials) | |||
| CHU Poitiers - Poitiers - France | Maria Pilar GALLEGO HERNANZ, Dr | Contact (sur clinicalTrials) | |||
| CHU Tours - Tours - France | Antoine MACHET, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient ≥ 18 year-old.
- AND medical follow-up in hematology unit
- AND had received a first course of chemotherapy for diffuse large B cell lymphoma or
for follicular lymphoma
- Life expectancy > 6 months.
- Negative pregnancy test.
- Having signed the consent form.
- Having an health insurance.
- Patient ≥ 18 year-old.
- AND medical follow-up in hematology unit
- AND had received a first course of chemotherapy for diffuse large B cell lymphoma or
for follicular lymphoma
- Life expectancy > 6 months.
- Negative pregnancy test.
- Having signed the consent form.
- Having an health insurance.
- Receiving monoclonal antibodies or biotherapies altering the immune response, other
than anti-CD20 antibodies in the chemotherapy protocol.
- Uncontrolled bacterial, viral or fungal infection less than 7 days.
- Previous vaccination with PCV13 or PPV23 (unless PCV13 was administered in
childhood. The last injection must be performed at least five years ago).
- 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.
- Patient who already received chemotherapy for malignancy in the previous 2 years
before the inclusion.
- Major blood clotting disorders preventing intramuscular injection.
- Medical history of anaphylactic reaction to vaccination.
- Known allergy to one of the vaccine components.
- Involvement to another vaccine biomedical research.
- Protected person.
- Pregnant women or women of childbearing age without appropriate contraceptive
measures.
- Perfusion of polyvalent immunoglobulins during follow-up.
- Participants with hypersensitivity to aluminum phosphate, phenol or CRM197 protein,
protein derived from Corynebacterium diphtheria.