Status:
UNKNOWN
Preservation and Transfer of HBV Immunity After Allogeneic HSCT for SCD
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
16-60 years
Phase:
NA
Brief Summary
Sickle cell disease (SCD) patients ending with mixed mononuclear chimerism after non-myeloablative HSCT with alemtuzumab/TBI conditioning will probably preserve their immune response to vaccinations a...
Detailed Description
Rationale: Sickle cell disease (SCD) is an inherited hemoglobinopathy, characterized by chronic hemolytic anemia and microvascular occlusions leading to pain attacks and progressive deterioration of o...
Eligibility Criteria
Inclusion
- Age 18 or older
- High performance liquid chromatography (HPLC) confirmed diagnosis of SCD (not applicable to participating donors).
- An indication for and a planned matched sibling or haploidentical donor non-myeloablative HSCT at the Amsterdam UMC, location AMC (not applicable to patients in cohort 2 (control group) and participating donors)
- Written informed consent
Exclusion
- History of either cleared, chronic or active HBV infection (positive HBsAg, anti-HBs, anti-HBc and/or HBV DNA)
- History of auto-immune diseases and/or use of immunosuppressive drugs
- History of HIV infection
- Known hypersensitivity to yeast of any vaccine constituent
- Donor with a history of HBV infection
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05200338
Start Date
June 8 2021
End Date
December 1 2024
Last Update
June 8 2023
Active Locations (1)
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1
Amsterdam Medical Centre
Amsterdam, Netherlands, 1105AZ