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Study on the Immune Response to Hepatitis B Vaccine in Bone Marrow Transplant Patients

Investigating the immune response to hepatitis B vaccine in patients undergoing bone marrow transplantation: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140818018842N45
Enrollment
440
Registered
2025-01-19
Start date
2025-02-13
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Hepatitis B vaccine. Condition 2: Bone marrow transplant. viral vaccine

Interventions

Intervention 1: Intervention group:Patients in the intervention group will receive hepatitis B vaccinations, six months after transplantation, provided they are not receiving immunosuppressive medica

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 65 years old Participants must have undergone either allogeneic or autologous bone marrow transplantation. At least 6 months must have passed since the date of transplantation. Hepatitis Test Results: Participants must have negative HBs Ag and HBC Ab titers.

Exclusion criteria

Exclusion criteria: Use of immunosuppressive medication Active GVHD grade 3 and 4 History of chronic hepatitis B Prophylactic treatment with tenofovir due to positive HBc Ab Lack of consent

Design outcomes

Primary

MeasureTime frame
Anti-HBs seroconversion. Timepoint: Before the administration of the first dose of the vaccine, three weeks after the first dose, and one to two months after the third dose. Method of measurement: blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeyla Sharifi Aliabadi

Tehran University of Medical Sciences

ctu@sina.tums.ac.ir+98 21 8490 2635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026