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

About the study

We hypothesize, that sickle cell disease (SCD) patients ending with mixed mononuclear chimerism after non-myeloablative HSCT with alemtuzumab/TBI conditioning will preserve their immune response to vaccinations administered prior to the transplantation and will therefore not need to be revaccinated. Furthermore, we hypothesize, that SCD patients after haploidentical HSCT can benefit from adoptive transfer of immunity from their donors.

To test the first hypothesis, we will vaccinate patients undergoing the alemtuzumab/TBI HSCT with a hepatitis B virus (HBV) vaccine before the transplant. To test the second hypothesis, we will vaccinate haploidentical and matched related donors 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, we will be able to evaluate whether SCD patients preserve their pre-transplant immune response in the post-transplantation period. Furthermore, we will determine whether donors transfer their immunity to HSCT recipients with SCD disease.

Study point of contact

Erfan Nur, MD, PhD
0031-20-4442604
[email protected]
Management hematology
0031-20-4442604
[email protected]

Locations

1 Netherlands site

Age

16 Years - 60 Years

Phase

Not Applicable

Study type

Interventional

Gender

All

Interventions

Drug

participation requirements

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

participation restrictions

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

Locations

  • Amsterdam, Netherlands, Amsterdam Medical Centre
Last updated 2022-01-06