Sickle cell disease
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of SCD patients with a preserved anti-HBs response following non-myeloablative allogeneic HSCT with an HBV naive matched sibling donor (cohort 1) at 12 months post-transplantation as compared to SCD patients without HSCT (cohort 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| - The proportion of SCD patients with a preserved anti-HBs response following non-myeloablative allogeneic HSCT with an HBV naive MSD (cohort 1) at 3-, 6-, and 24 months post-transplantation as compared to SCD patients without HSCT (cohort 2). - The proportion of SCD patients with an adoptive transfer of anti-HBs response following non-myeloablative haploidentical HSCT with an HBV vaccinated donor at 3-, 6-, 12- and 24- months post-transplantation (cohort 3a). - The proportion of SCD patients with an adoptive transfer of anti-HBs response following non-myeloablative MSD HSCT with an HBV vaccinated donor at 3-, 6-, 12- and 24- months post-transplantation (cohort 3b). - Serum total IgG level and peripheral blood T-lymphocyte subset counts (CD3+, CD4+, CD8+), B-lymphocyte subset counts (CD19+) and NK cell count, at 3-, 6-, 12- and 24-months post-transplantation as compared to counts before the start of (pre-)conditioning. | — |
Contacts
Public ContactElisabeth (Lisa) Dovern
Amsterdam UMC, location AMC
Outcome results
None listed