Preserving immunity in sickle cell disease patients after stem cell transplantation
Preservation and Transfer of Hepatitis B Virus Immunity After Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation in Adult Sickle Cell Disease Patients (Protect Study)
This study is testing if sickle cell disease patients can keep their immunity to hepatitis B after getting a stem cell transplant and whether receiving immune support from vaccinated donors helps.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 16 Years to 60 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | alemtuzumab, cyclophosphamide, fludarabine |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05200338 on ClinicalTrials.gov |
What this trial studies
This study investigates whether sickle cell disease (SCD) patients who undergo non-myeloablative hematopoietic stem cell transplantation (HSCT) with alemtuzumab and total body irradiation can maintain their immune response to hepatitis B vaccinations given before the transplant. Additionally, it explores the potential benefits of adoptive immunity transfer from vaccinated haploidentical donors. The study will evaluate the immune response of patients post-transplantation to determine if they require revaccination. The research is conducted at the Amsterdam Medical Centre.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a confirmed diagnosis of sickle cell disease who are scheduled for matched sibling or haploidentical donor HSCT.
Not a fit: Patients with a history of hepatitis B infection or autoimmune diseases, or those on immunosuppressive drugs, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could eliminate the need for revaccination against hepatitis B in SCD patients after transplantation.
How similar studies have performed: While the approach of preserving immunity post-transplantation is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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: * 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
Where this trial is running
Amsterdam
- Amsterdam Medical Centre — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Erfan Nur, MD, PhD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Erfan Nur, MD, PhD
- Email: e.nur@amsterdamumc.nl
- Phone: 0031-20-4442604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.