Clinical trial NCT05967650: Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients
Official title: Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Hepatitis B vaccines
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Detailed 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. The pathogenesis of IBD involves genetic factors and environmental factors . In Egypt, the prevalence of IBD has been increasing in recent years.

Patients with inflammatory bowel illnesses are more susceptible to viral infections. In people with IBD, viral infections have emerged as a significant issue. Viral infections are often difficult to identify and have a high morbidity and fatality rate.

The hepatitis B virus is a widespread infection worldwide. HBV is a DNA virus of the Hepadnaviridae family that is a significant cause of morbidity and mortality . Hepatitis B virus (HBV) infection is a global health problem with a continuously increasing burden in developing countries like Egypt.

The prevalence of HBV in Egypt remains a significant public health concern, with a pooled prevalence of 3.67%. However, the introduction of the HBV vaccination program in 1992 has led to a decrease in prevalence among low-risk populations, with a pooled prevalence estimate of 1.93%. This highlights the importance of continued efforts to promote and expand HBV vaccination programs in Egypt.Notably, children under 20 with a history of HBV vaccination in infancy had the lowest prevalence of 0.69%, indicating the effectiveness of HBV vaccination during infancy in providing adequate protection. This underscores the need for increasing vaccination coverage among infants and young children in Egypt.However, the prevalence of HBV in pregnant females was still high among low-risk groups, with a pooled prevalence of 2.9%. This highlights the importance of targeted interventions to prevent mother-to-child transmission of HBV, such as screening pregnant women for HBV and providing antiviral therapy to those who test positive.Overall, while progress has been made in reducing the prevalence of HBV in Egypt, continued efforts are needed to further decrease the burden of this disease and prevent its transmission.

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. An accelerated HBV vaccine regimen has been developed that allows for faster immunity with fewer doses, but its efficacy in IBD patients to be investigated.\[5\]

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

Primary outcomes:
measure: - efficacy of accelerated HBV vaccine regimen versus standard HBV vaccine regiment among IBD patients already receive treatment
timeFrame: 7 months
Secondary outcomes:
measure: frequency of IBD patients with negative HBs Ab
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: bahaa os taha
role: STUDY_CHAIR
affiliation: Assiut University
name: lobna ah abdelwahed
role: STUDY_DIRECTOR
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