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Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients
Sponsor: Assiut University
Summary
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect young populations, altering their quality of life and increasing morbidity, compared to the general population . The etiology and pathogenesis of IBD are still poorly understood. Inflammatory bowel disease (IBD) patients are at an increased risk of contracting and developing complications from hepatitis B virus (HBV) due to their weakened immune systems and frequent use of immunosuppressive medications. The traditional HBV vaccine regimen requires three doses over six months to achieve full immunity, which can be challenging for IBD patients who may have difficulty adhering to the schedule or may not respond well to the vaccine
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-01-01
Completion Date
2026-03-01
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
standard hepatitis B vaccine
This study utilized a two-step design. Initially, 100 consecutive patients with inflammatory bowel disease (IBD) underwent baseline serological screening for hepatitis B virus (HBV), including HBsAg, total anti-HBc, and anti-HBs. Protective immunity was defined as an anti-HBs concentration of 10 mIU/mL. Following the screening phase, patients lacking HBV immunity (non-vaccinated or non-immune) were randomized to receive either an accelerated or a standard HBV vaccination regimen as pilot study
accelerated HBV Vaccine
IBD patients with negative HBV will be diveded in to two arms second arm vaccinated with accelerated HBV vaccine regemin( dose 1.2.3)
Locations (1)
Assiut Unnversity
Asyut, Asyut Governorate, Egypt