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Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma

RecruitingPhase 4Ages 18 Years - anyAllPoitiers University Hospital
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patient โ‰ฅ 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. Exclusion Criteria: * 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.
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What it tests

  • Prevenar 13 + Pneumovax 23
  • PREVENAR20
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Where

7 sites
Chu Angers
Angers, France
CHU Bordeaux
Bordeaux, France
CHU Limoges
Limoges, France
Chu Nantes
Nantes, France
Ch Perigueux
Pรฉrigueux, France
CHU Poitiers
Poitiers, France
CHU Tours
Tours, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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