Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Lymphoma, Non-Hodgkin

Pneumonia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Pneumonia, Pneumococcal

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

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Respiratory Tract Infections

Lung Diseases

Respiratory Tract Diseases

Pneumococcal Infections

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Bacterial Infections and Mycoses

Pneumonia, Bacterial

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All Drugs and Chemicals

Heptavalent Pneumococcal Conjugate Vaccine

Vaccines

Immunologic Factors

All patients will be vaccinated according to national guidelines

Vaccination according national guidelines

Prevenar13 Pneumo-23

Mathieu Puyade, MD, PhD

Fanny Abriat

Mathilde HUNAULT, Pr

François-Xavier GROS, Dr

Arnaud JACCARD, Pr

Pierre PETERLIN, Dr

Maria Pilar GALLEGO HERNANZ, Dr

Claire CALMETTES, Dr

Antoine MACHET, Dr

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.

Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma

Immunogénicité de la Vaccination Anti-pneumococcique Dans la leucémie aiguë et le Lymphome Chez l'Adulte

Proportion of patients having a good response to combined strategy at 4 weeks after the end of the combined strategy. A good response to vaccination is defined by 4/7 tested serotypes responding to these 4 criteria: a serotype-specific immunoglobulin G titer ≥ 1μg/L (WHO threshold), a two-fold increase of this immunoglobulin G titer compare to baseline before vaccination, a serotype-specific opsonophagocytic activity ≥1/8, and a four-fold increase of functional antibodies compare to baseline.

Poitiers University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma	NCT04460235	Vaccine Streptococcus P... Acute Myeloid L... Lymphoma, Non-H...	Prevenar13 Pneu...	18 Years -	Poitiers University Hospital
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma	NCT04460235	Vaccine Streptococcus P... Acute Myeloid L... Lymphoma, Non-H...	Prevenar13 Pneu...	18 Years -	Poitiers University Hospital

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