Vaccine-Induced Anti-HBs Response Is Associated with Protection Against Hepatitis B Virus Reactivation after Allogeneic Hematopoietic Cell Transplantation: A Randomized Trial - PubMed

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Hepatitis B virus (HBV) reactivation is a complication in patients with resolved HBV infection undergoing allogeneic hematopoietic cell transplantation (allo-HCT).
This randomized trial evaluated if hepatitis B (HepB) vaccination reduces HBV reactivation and examined the association between vaccine-induced anti-HBs response and protection.
Patients without HBV reactivation at 140 days post-HCT were randomized to receive HepB vaccination or no vaccination, with monitoring for 2 years.
In the vaccination group, 6 out of 33 patients experienced HBV reactivation (including 2 before the first dose), compared to 9 out of 31 in the control group.
The probabilities of HBV reactivation were 19.8% in the vaccination group and 37.9% in the control group at 18 months, though the difference was not statistically significant (p = 0.205).
Baseline anti-HBs levels below 10 mIU/mL were a significant risk factor for HBV reactivation, and no HBV-related hepatitis occurred.
Vaccine responses were achieved in some patients, with no HBV reactivation observed after anti-HBs response was achieved.
The study concluded that HepB vaccination was feasible and induced anti-HBs response in a subset, potentially providing protective immunity against reactivation, though it did not significantly reduce reactivation overall.

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