Informations générales (source: ClinicalTrials.gov)

NCT04460235 En recrutement
Immunogénicité de la Vaccination Anti-pneumococcique Dans la leucémie aiguë et le Lymphome Chez l'Adulte (HEMATOVAC)
Interventional
  • Leucémies
  • Lymphomes
  • Lymphome malin non hodgkinien
  • Pneumopathie infectieuse
  • Pneumonie à pneumocoques
Phase 4
Poitiers University Hospital (Voir sur ClinicalTrials)
septembre 2021
juin 2026
29 juin 2024
The French Public Health Council recommended pneumococcal vaccination combined strategy for all immunocompromised patients in 2012. This strategy consisted in conjugated 13-valent pneumococcal injection followed 2 months later by polysaccharide 23-valent vaccine injection. 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 70% of the patients are non-responders to vaccination, according to their anti-pneumococcal immunoglobulin G titers and the opsonophagocytic activity. To assess the immunogenicity of the pneumococcal vaccination combined strategy in adult population of acute leukemia and lymphoma, the investigator will measure anti-pneumococcal serotype-specific immunoglobulin G titers and opsonophagocytic activity 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 13-valent pneumococcal injection (corresponding to 1 month after the end of the combined strategy) using immunoglobulin G titers and opsonophagocytic activity. At different time points (day 0, 1 month after the 13-valent pneumococcal injection, the day of the injection of the polysaccharide 23-valent vaccine, one month after the injection of the polysaccharide 23-valent vaccine, 3-6 months after the polysaccharide 23-valent vaccine,9-12 months after the polysaccharide 23-valent vaccine), the immunological response to vaccination will be monitored using specific-serotype immunoglobulin G titers, opsonophagocytic activity, and total anti-pneumococcal Immunoglobulin. The investigator will determine predictive factors of non-response to vaccination by comparing demographic data, biological data and treatment received by both acute myeloblastic leukemia and lymphoma patients. The tolerance and safety of the vaccination strategy will also be assessed in this specific hematological population.
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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 En recrutement 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 En recrutement Contact (sur clinicalTrials)
CHU Bordeaux - Bordeaux - France François-Xavier GROS, Dr En recrutement Contact (sur clinicalTrials)
CHU Limoges - Limoges - France Arnaud JACCARD, Pr En recrutement Contact (sur clinicalTrials)
Chu Nantes - Nantes - France Pierre PETERLIN, Dr En recrutement Contact (sur clinicalTrials)
CHU Poitiers - Poitiers - France Maria Pilar GALLEGO HERNANZ, Dr En recrutement Contact (sur clinicalTrials)
CHU Tours - Tours - France Antoine MACHET, Dr En recrutement 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 except demethylating for acute
myeloblastic leukemia without ProMyelogenousLeukemia-RetinoicAcidReceptor alpha and
no planned allogeneic hematopoietic stem cell transplantation (anti-IDH treatment
authorized) or for diffuse large B cell lymphoma or for follicular lymphoma

- Life expectancy > 6 months

- Having signed the consent form

- Having an health insurance


- Receiving monoclonal antibodies or biotherapies altering the immune response, other
than anti-Cluster of differentiation number 20 antibodies in the chemotherapy
protocol.

- Uncontrolled bacterial, viral or fungal infection less than 7 days

- Previous vaccination with 13-valent pneumococcal vaccine or polysaccharide 23-valent
vaccine (unless 13-valent pneumococcal vaccine 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

- Allogeneic hematopoietic stem cell transplantation planned in the following 3 months
after the first chemotherapy course

- 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.