Clinical trial NCT04460235: Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
Official title: Immunogénicité de la Vaccination Anti-pneumococcique Dans la leucémie aiguë et le Lymphome Chez l'Adulte
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Vaccine
Streptococcus Pneumoniae
Acute Myeloid Leukemia
Lymphoma, Non-Hodgkin
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of patients having a good response to combined strategy
timeFrame: 39 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Limoges
country: France
facility: CHU Limoges
city: Nantes
country: France
facility: Chu Nantes
city: Poitiers
country: France
facility: CHU Poitiers
city: Périgueux
country: France
facility: Ch Perigueux
city: Tours
country: France
facility: CHU Tours
Study officials:
References: