Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients

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

Phase 1: Serological Screening Inclusion Criteria: Confirmed diagnosis of inflammatory bowel disease (IBD). Exclusion Criteria: Refusal to provide informed consent for the screening phase. Phase 2: Vaccination and Randomization Inclusion Criteria: Completed Phase 1 serological screening. Seronegative for hepatitis B surface antigen (HBsAg). Non-immune to HBV, defined as a hepatitis B surface antibody (anti-HBs) concentration of \< 10 mIU/mL. Exclusion Criteria: Evidence of active or past HBV infection (e.g., positive HBsAg or positive total anti-HBc identified during Phase 1). History of recent HBV vaccination (note: prior routine childhood HBV vaccination administered during infancy is permitted and is not an exclusion) Refusal to participate in the vaccination and randomization phase.