Preservation and Transfer of Hepatitis B Virus Immunity after Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation in Adult Sickle Cell Disease Patients.
- Conditions
- Sickle cell disease
- Registration Number
- NL-OMON23265
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 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
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method