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

Launched by POITIERS UNIVERSITY HOSPITAL · Jul 6, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a combined pneumococcal vaccination strategy in adults with acute leukemia or lymphoma. The vaccination approach involves giving a 13-valent pneumococcal vaccine followed by a 23-valent polysaccharide vaccine two months later. The goal is to see how well these vaccines boost the immune response in patients whose immune systems may be weakened by chemotherapy, as they are at a higher risk of serious infections from pneumococcus bacteria. Researchers will measure the immune response at various time points after vaccination to understand how well the vaccines work in this specific patient group.

To be eligible for the trial, participants must be at least 18 years old, currently receiving treatment in a hematology unit, and have completed their first course of chemotherapy for certain types of leukemia or lymphoma. They should also expect to live for more than six months and provide consent to participate. Throughout the trial, participants will have their immune response closely monitored, and the safety of the vaccination strategy will be assessed. This study is currently recruiting participants, and it's important for those interested to discuss their eligibility with their healthcare provider.

Gender

ALL

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.