Preservation and Transfer of HBV Immunity After Allogeneic HSCT for SCD.

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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