NCT04460235 Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma
| NCT ID | NCT04460235 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Poitiers University Hospital |
| Condition | Vaccine |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2021-09-07 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2021-09-07 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04460235 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vaccine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04460235 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04460235 currently recruiting?
Yes, NCT04460235 is actively recruiting participants. Contact the research team at mathieu.puyade@chu-poitiers.fr for enrollment information.
Where is the NCT04460235 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, Limoges, France, Nantes, France and 3 additional locations.
Who is sponsoring the NCT04460235 clinical trial?
NCT04460235 is sponsored by Poitiers University Hospital. The trial plans to enroll 160 participants.