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

Recruiting

Conditions: hemoglobinopathy
Sickle cell disease
10018902

Registration Number: NL-OMON52342

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 42

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

- 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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: proportion of SCD patients with a preserved anti-HBs response<br /><br>following non-myeloablative HSCT with an HBV naive MSD (cohort 1a), compared to<br /><br>SCD patients not undergoing HSCT (cohort 2). </p><br>

Secondary Outcome Measures

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