Status:
COMPLETED
Immunogenicity Study of an Anti-pneumococcal Vaccination Strategy in Patients With Sickle Cells Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Invasive Pneumococcal Infections
Sickle Cells Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Streptococcus pneumoniae is the major cause of bacterial infection in patients with sickle cells disease. The 23-valent pneumococcal polysaccharide vaccine (PSV) is supposed to be poorly immunogenic ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Adult patient with sickle cell anemia (SS homozygous, SC heterozygous compound Sbetathal heterozygous)
Exclusion
- Heterozygous sickle cell anemia
- Active infection
- Hypersensitivity known or suspected to Prevenar 13® or to Pneumo 23® or to any of the excipients included in the formulation or in the administration system
- Coagulation abnormality indicating against an intramuscular injection (Platelets \<50 000 or TP\<50%)
- Current chemotherapy or radiotherapy, except for using Siklos®/Hydrea® in the context of sickle cell anemia
- Vaccination whatever in the last 2 months before the protocol vaccination, except influenza vaccination (within 30 days)
- Vaccination whatever, provided in the first 2 months following the protocol vaccinations, except influenza vaccination (within the first month following the protocol vaccinations))
- History of pneumococcal vaccination with Pneumo 23® in the previous year
- End-stage renal failure(dialyzed patient, clearance\<10ml/mn)
- HIV infection at baseline
- Pregnancy or breastfeeding (A dosage of betaHCG will be conducted for women in childbearing age),contraception recommendation the first 8 weeks of the test for women in childbearing age
- Participation in a clinical research protocol using a drug within the month prior to inclusion.
- No medical assurance
- Adults under tutelage
Key Trial Info
Start Date :
September 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2019
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT02274415
Start Date
September 16 2013
End Date
April 10 2019
Last Update
September 9 2022
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France, 94010