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Pneumoccocal vaccine response in patients without a spleen, vaccinated before or after spleen removal.
EU CTIS ID: 2024-515363-63-00
What this study is testing
To assess the impact of splenectomy on the induction of immunological memory after vaccination with PCV20 primary vaccination, measured as the serological response 3 week after booster vaccination with PCV21, in asplenic patients primed before or after splenectomy, for PS present in both vaccines (common serotypes).
- 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
- Patients with newly induced anatomical asplenia, of which the underlying cause can be: en-bloc splenectomy during pancreatic surgery because of pancreatic cancer or precancerous pancreatic lesions, or splenectomy for haematological diseases (thalassemia or sickle cell disease)
- Patients scheduled for (en bloc) splenectomy, of which the underlying caused can be as prescribed above
- Participants aged 18 years and older
- Participants should have provided signed informed consent
- Participants should be naïve for other PCVs, except for PCV20
You likely can't join if
- Known hypersensitivity or allergy to any vaccine component
- Pregnancy during the entire course of the study
- Documented active haematological malignancy
- Documented primary coagulopathy
- Ongoing B or T cell immune deficiency such as a primary immune disorder or secondary immune disorder, such as documented HIV infection
- Current use of any immunosuppressive drug (except NSAIDs)
See the full eligibility criteria
- Patients with newly induced anatomical asplenia, of which the underlying cause can be: en-bloc splenectomy during pancreatic surgery because of pancreatic cancer or precancerous pancreatic lesions, or splenectomy for haematological diseases (thalassemia or sickle cell disease)
- Patients scheduled for (en bloc) splenectomy, of which the underlying caused can be as prescribed above
- Participants aged 18 years and older
- Participants should have provided signed informed consent
- Participants should be naïve for other PCVs, except for PCV20
- Known hypersensitivity or allergy to any vaccine component
- Pregnancy during the entire course of the study
- Documented active haematological malignancy
- Documented primary coagulopathy
- Ongoing B or T cell immune deficiency such as a primary immune disorder or secondary immune disorder, such as documented HIV infection
- Current use of any immunosuppressive drug (except NSAIDs)
- Acute febrile illness at time inclusion
- Receipt of PPV23 in the past year
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.
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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.