Clinical trial

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

Name
HBV vaccines in IBD patients
Description
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
Trial arms
Trial start
2023-09-01
Estimated PCD
2024-09-01
Trial end
2024-10-01
Status
Not yet recruiting
Treatment
standard hepatitis B vaccine
IBD patients with negative HBV will be diveded in to two arms first arm vaccinated with standard HBV vaccine regemin( dose 0.2.6)
Arms:
HBV vaccination of Inflammatory bowel disease patients with stander regemin
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)
Arms:
HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin
Size
200
Primary endpoint
- efficacy of accelerated HBV vaccine regimen versus standard HBV vaccine regiment among IBD patients already receive treatment
7 months
Eligibility criteria
Inclusion Criteria: * IBD patients with negative HBs Ag and HBsAb less than 10 Exclusion Criteria: * Patients who refuse enter the study * Patients who already have HBV infection * Patients who had HBV vaccine recently
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-08-01

1 organization

2 products

1 indication

Organization
Assiut University