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HEMATOVAC-Immunogenicity of an Anti-pneumococcal Combined Vaccination (PCV13+PPV23 versus PREVENAR20) in Lymphoma
EU CTIS ID: 2024-517288-22-01
What this study is testing
To compare the immunogenicity of the combined pneumococcal vaccination strategy (PCV13+ PPV23 (Cohort A)) with the new strategy recommended by HAS using a single injection of PREVENAR20 (Cohort B) in adult subjects treated with cytotoxic chemotherapy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Receiving monoclonal antibodies or biotherapies altering the immune response, other than anti-CD20 antibodies in the chemotherapy protocol
- 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 research
See the full eligibility 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
- Free subject, without guardianship, tutorship or subordination
- Receiving monoclonal antibodies or biotherapies altering the immune response, other than anti-CD20 antibodies in the chemotherapy protocol
- 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 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.