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

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Sickle cell disease (SCD) patients ending with mixed mononuclear chimerism after non-myeloablative HSCT with alemtuzumab/TBI conditioning will probably preserve their immune response to vaccinations administered prior to the transplantation and will therefore not need to be revaccinated. Furthermore, SCD patients after haploidentical HSCT might benefit from adoptive transfer of immunity from their donors. To test the first hypothesis, patients undergoing alemtuzumab/TBI HSCT will be vaccinated with a hepatitis B virus (HBV) vaccine before the transplant. To test the second hypothesis, haploidentical and matched related donors will be vaccinated prior to stem cell donation against HBV. Neither the patient nor the donor may previously have been immunized against HBV in all cohorts. Post-transplantation, the investigators will be able to evaluate whether SCD patients preserve their pre-transplant immune response in the post-transplantation period. Furthermore, the investigators will determine whether donors transfer their immunity to HSCT recipients with SCD disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam Medical Centre
RECRUITING
Amsterdam
Contact Information
Primary
Erfan Nur, MD, PhD
e.nur@amsterdamumc.nl
0031-20-4442604
Backup
Management hematology
hematology@amsterdamumc.nl
0031-20-4442604
Time Frame
Start Date: 2021-06-08
Completion Date: 2024-12
Participants
Target number of participants: 30
Treatments
Other: Cohort 1a
SCD patients that are vaccinated against hepatitis B virus before matched sibling donor allogeneic SCT.
Other: Cohort 1b
SCD patients that are vaccinated against hepatitis B virus before haploidentical donor allogeneic SCT.
Other: Cohort 2
SCD patients that are vaccinated against hepatitis B virus without undergoing allogeneic SCT (control group).
Other: Cohort 3a
SCD patients undergoing matched sibling donor allogeneic SCT whose donor is vaccinated against hepatitis B virus before stem cell collection.
Other: Cohort 3b
SCD patients undergoing haploidentical donor allogeneic SCT whose donor is vaccinated against hepatitis B virus before stem cell collection.
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov

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