Preservation and Transfer of Hepatitis B Virus Immunity after Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation in Adult Sickle Cell Disease Patients (Protect Study).

Preservation and Transfer of Hepatitis B Virus Immunity after Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation in Adult Sickle Cell Disease Patients (Protect Study). - Preservation and Transfer of HBV Immunity after HSCT for SCD.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52342

Enrollment

Registered

2021-06-22

Start date

2021-07-08

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemoglobinopathy Sickle cell disease

Interventions

None listed

Eligibility

Age

16 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age 16 years 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: - 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
Primary endpoint: proportion of SCD patients with a preserved anti-HBs response following non-myeloablative HSCT with an HBV naive MSD (cohort 1a), compared to SCD patients not undergoing HSCT (cohort 2).	—

Secondary

Measure	Time frame
Secondary endpoints: Proportion of SCD patients with a preserved HBV specific cellular immune response following non-myeloablative HSCT with an HBV naive MSD. Proportion of SCD patients with a preserved anti-HBs response and/or HBV specific cellular immune respone following non-myeloablative HSCT with an HBV naive haploidentical donor (cohort 1b). Proportion of SCD patients adopting their donors anti-HBs and/or HBV specific cellular immune response following non-myeloablative HSCT (cohort 3a and 3b). Immune reconstitution as expressed by serum total IgG levels and peripheral blood T-lymphocyte subset counts (CD3+, CD4+, CD8+), B-lymphocyte subset counts (CD19+) and Natural Killer (NK) cell counts at 3-, 6-, 12- and 24-months post-transplantation as compared to baseline (pre-transplantation) values.	—

Measure

Time frame

Secondary endpoints: Proportion of SCD patients with a preserved HBV specific cellular immune response following non-myeloablative HSCT with an HBV naive MSD. Proportion of SCD patients with a preserved anti-HBs response and/or HBV specific cellular immune respone following non-myeloablative HSCT with an HBV naive haploidentical donor (cohort 1b). Proportion of SCD patients adopting their donors anti-HBs and/or HBV specific cellular immune response following non-myeloablative HSCT (cohort 3a and 3b). Immune reconstitution as expressed by serum total IgG levels and peripheral blood T-lymphocyte subset counts (CD3+, CD4+, CD8+), B-lymphocyte subset counts (CD19+) and Natural Killer (NK) cell counts at 3-, 6-, 12- and 24-months post-transplantation as compared to baseline (pre-transplantation) values.

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Countries

Netherlands

Outcome results