Evaluating a combined pneumococcal vaccination for patients with acute leukemia or lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the immunogenicity of a combined pneumococcal vaccination strategy in patients with acute leukemia or lymphoma who are undergoing chemotherapy. The vaccination consists of a 13-valent conjugated pneumococcal vaccine followed by a 23-valent polysaccharide vaccine two months later. Given that these patients have compromised immune systems, the study aims to assess their response to the vaccination by measuring anti-pneumococcal immunoglobulin G titers and opsonophagocytic activity. The goal is to determine the effectiveness of this vaccination approach in reducing the risk of pneumococcal invasive diseases in this vulnerable population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chu Angers
  Angers, France Recruiting
• CHU Limoges
  Limoges, France Recruiting
• Ch Perigueux
  Périgueux, France Recruiting
• CHU Poitiers
  Poitiers, France Recruiting
• CHU Tours
  Tours, France Recruiting
• CHU Bordeaux
  Bordeaux, France Terminated

Study contacts

• Study coordinator: Mathieu Puyade, MD, PhD
• Email: mathieu.puyade@chu-poitiers.fr
• Phone: 0033 5 49 44 32 76

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.