NCT05967650Completed
Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 8 Jul 2023
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Assiut University
- Diseases
- Hepatitis B
- NCT number
- NCT05967650
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 1 Jan 2025 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of recent HBV vaccination (note: prior routine childhood HBV vaccination administered during infancy is permitted and is not an exclusion)
Other illness
- Evidence of active or past HBV infection (e.g., positive HBsAg or positive total anti-HBc identified during Phase 1).
Other
- Refusal to provide informed consent for the screening phase.
- Phase 2: Vaccination and Randomization
- Refusal to participate in the vaccination and randomization phase.
Who the study is looking for
- Confirmed diagnosis of inflammatory bowel disease (IBD).
- 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.
Criteria the registry did not label
- Phase 1: Serological Screening
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assiut Unnversity Coordinator of this site? Confirm its status | Asyut | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.