Status:
RECRUITING
Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma
Lead Sponsor:
Poitiers University Hospital
Conditions:
Vaccine
Streptococcus Pneumoniae
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04460235
Start Date
September 7 2021
End Date
November 1 2027
Last Update
July 1 2025
Active Locations (7)
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1
Chu Angers
Angers, France
2
CHU Bordeaux
Bordeaux, France
3
CHU Limoges
Limoges, France
4
Chu Nantes
Nantes, France