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

July 27, 2023 updated by: Maria Sabry, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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]

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HBV vaccination of Inflammatory bowel disease patients with stander regemin

inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination

  1. st dose zero
  2. nd dose after 2 months
  3. rd dose after 6 months
Biological: 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)
Active Comparator: HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin

inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination

  1. st dose zero
  2. nd dose after 1months
  3. rd dose after 3 months
Biological: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- efficacy of accelerated HBV vaccine regimen versus standard HBV vaccine regiment among IBD patients already receive treatment
Time Frame: 7 months
accelearted HBV vaccine will be given at( dose 0 ,1,3) mothns while standard HBV vaccine regemin( dose 0.2.6) efficacy of both regimen assessed by measurement of HBs Ab titre by IU
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of IBD patients with negative HBs Ab
Time Frame: 2 months
All IBD patients at Alraghy hospital will be tested for HBsAg, HBcAb and HBsAb titre by IU
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: bahaa os taha, Assiut University
  • Study Director: lobna ah abdelwahed, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

July 8, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV vaccines in IBD patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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