Actively Recruiting
Immunogenicity of Pneumococcal Vaccination Strategies (PCV13+PPV23 Versus PREVENAR20) in Adults Treated for Lymphoma
Led by Poitiers University Hospital · Updated on 2026-05-29
160
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the immune response to pneumococcal vaccination strategies in adults treated for lymphoma and acute leukemia. The study compares the traditional two-step vaccination approach using a 13-valent conjugate vaccine (PCV13) followed by a 23-valent polysaccharide vaccine (PPV23) against a newer guideline recommending a single injection of PREVENAR20. These patients often have weakened immune systems due to chemotherapy, increasing their risk for pneumococcal invasive diseases, but the effectiveness of these vaccination strategies in this group is not well documented. The trial includes two groups: one group of 80 patients received PCV13 followed by PPV23 at least two months later, and another group of 80 patients will receive a single PREVENAR20 injection. The study monitors immune responses at multiple points, including before vaccination, four weeks after each vaccine injection, and up to 14 months post-vaccination. Researchers measure specific antibodies and immune activity to evaluate how well each vaccination method prompts an immune response. Participants will undergo blood tests at several time points to measure pneumococcal antibody levels and immune activity. The study also assesses vaccine safety, looking for local or general reactions and any invasive pneumococcal infections. Researchers aim to identify factors that predict poor response to vaccination by comparing patient demographics, biological data, and treatments received. The total follow-up period extends to 14 months after vaccination to assess the durability of the immune response.
CONDITIONS
Brief Title
Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years or older
- Under medical follow-up in a hematology unit
- Received a first course of chemotherapy for diffuse large B cell lymphoma or follicular lymphoma
- Life expectancy greater than 6 months
- Negative pregnancy test
- Signed the consent form
- Has health insurance
You will not qualify if you...
- Receiving monoclonal antibodies or biotherapies altering immune response, except anti-CD20 antibodies in chemotherapy
- Uncontrolled bacterial, viral, or fungal infection within the last 7 days
- Previous vaccination with PCV13 or PPV23 within the last 5 years (except childhood PCV13)
- Preexisting immune-altering conditions such as splenectomy, HIV, immune deficiencies, nephrotic syndrome, sickle cell anemia, autoimmune disorders, organ transplant, or immunosuppressive drugs outside chemotherapy
- Received chemotherapy for malignancy in the past 2 years before inclusion
- Major blood clotting disorders preventing intramuscular injection
- History of anaphylactic reaction to vaccination
- Known allergy to vaccine components
- Participation in another vaccine biomedical research
- Protected person status
- Pregnant women or women of childbearing age without proper contraception
- Receiving polyvalent immunoglobulin infusion during follow-up
- Hypersensitivity to aluminum phosphate, phenol, or CRM197 protein or related proteins derived from Corynebacterium diphtheriae
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months depending on cohort
Participants receive vaccination according to their cohort assignment: either two injections (PCV13 followed by PPV23 at least 2 months later) or a single injection of PREVENAR20.
1 to 2 vaccination visits depending on cohort assignment
Duration - Up to 14 months
Participants are monitored for immunological response and vaccine safety through blood tests and clinical assessments over the following months.
Visits at 4 weeks, 3-6 months, 9-12 months, and 14 months post-vaccination
Trial Site Locations
Total: 7 locations
1
Chu Angers
Angers, France
Actively Recruiting
2
CHU Bordeaux
Bordeaux, France
Terminated
3
CHU Limoges
Limoges, France
Actively Recruiting
4
Chu Nantes
Nantes, France
Terminated
5
Ch Perigueux
Périgueux, France
Actively Recruiting
6
CHU Poitiers
Poitiers, France
Actively Recruiting
7
CHU Tours
Tours, France
Actively Recruiting
Research Team
M
Mathieu Puyade, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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