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Recruiting NCT04460235

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

Phase IV Interventional Vaccine Streptococcus Pneumoniae Lymphoma, Non-Hodgkin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prevenar 13 + Pneumovax 23, PREVENAR20.
Who it may be relevant to
Registry conditions: Vaccine, Streptococcus Pneumoniae, Lymphoma, Non-Hodgkin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Immunogénicité de la Vaccination Anti-pneumococcique (PCV13+PPV23 Versus PREVENAR20) Dans le Lymphome Chez l'Adulte

Overview

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 setting. We assume that 65% of the patients are non-responders to double compared to 45% for PCV20PREVENAR20 vaccination, according to their anti-pneumococcal immunoglobulin G (Ig) titers and the opsonophagocytic activity (OPA). To assess the immunogenicity of the pneumococcal vaccination combined strategy in adult population of acute leukemia and lymphoma, we will measure anti-pneumococcal serotype-specific IgG titers and OPA 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 PCV13 injection (corresponding to 1 month after the end of the combined strategy in cohort A) using Ig G titers and OPA, compared to 3 months post PREVENAR20 (cohort B). At different time points (day 0, 4 weeks post PCV13, and 4 weeks, 3-6 months and 9-12 months post PPV23 and in day 0, 4 weeks post PREVENAR20 and 3 months, 5-8 months and 11-14 months post PREVENAR20, the immunological response to vaccination will be monitored using specific-serotype IgG titers, OPA, and total anti-pneumococcal Ig. We will determine predictive factors of non-response to vaccination by comparing demographic data, biological data and treatment received lymphoma patients. The tolerance and safety of the vaccination strategy will also be assessed in this specific hematological population.

Interventions

  • Biological Prevenar 13 + Pneumovax 23
    Cohort study A before modification of vaccination national guidelines
  • Biological PREVENAR20
    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. Cohort study B

Primary outcome measures

  • Proportion of patients having an immunological response [Time frame: 4 weeks after the end of the combined strategy for cohort study A and 3 months post injection for cohort study B]
Secondary outcome measures (7)
  • Proportion of patients having an ELISA serotype-specific IgG titer and a two-fold increase of this IgG titer [Time frame: 4 weeks after injection]
  • Proportion of patients having a sustainable response to vaccination [Time frame: 3-6 months after the PPV23 injection or 5-8 months post PREVENAR20]
  • Proportion of patients having a sustainable response to vaccination [Time frame: 9-12 months after the PPV23 injection or 11-14 months post PREVENAR20.]
  • Proportion of responding patients having titers of IgG, IgG2, IgM, and IgA rising significantly [Time frame: 4 weeks after PCV13 or PREVENAR20 injection, and 4 weeks, 3-6 months and 9-12 months after PPV23 injection versus respectively 3 months, 5-8 months and 11-14 months after PREVENAR20 injection.]
  • Predictive factors for non-response to vaccination [Time frame: 4 weeks, and 9-12 months after PPV23 versus respectively 3 months and 11-14 months after PREVENAR20 injection]
  • Local or general reactions to vaccination and invasive pneumococcal infections [Time frame: 14 months]
  • Concordance between the reference immuno-monitoring dosage and another kit of dosage [Time frame: 14 months]

Eligibility criteria

Inclusion criteria

  • Patient ≥ 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

France · 7 centers
  • Chu Angers — Angers
  • CHU Bordeaux — Bordeaux
  • CHU Limoges — Limoges
  • Chu Nantes — Nantes
  • Ch Perigueux — Périgueux
  • CHU Poitiers — Poitiers
  • CHU Tours — Tours

Identifiers

NCT: NCT04460235 · HEMATOVAC · 2024-517288-22-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗