search
Back to results

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

Primary Purpose

Inflammatory Bowel Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
standard hepatitis B vaccine
accelerated HBV Vaccine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Inflammatory Bowel Diseases focused on measuring Hepatitis B vaccines

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    HBV vaccination of Inflammatory bowel disease patients with stander regemin

    HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin

    Arm Description

    inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination st dose zero nd dose after 2 months rd dose after 6 months

    inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination st dose zero nd dose after 1months rd dose after 3 months

    Outcomes

    Primary Outcome Measures

    - efficacy of accelerated HBV vaccine regimen versus standard HBV vaccine regiment among IBD patients already receive treatment
    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

    Secondary Outcome Measures

    frequency of IBD patients with negative HBs Ab
    All IBD patients at Alraghy hospital will be tested for HBsAg, HBcAb and HBsAb titre by IU

    Full Information

    First Posted
    July 8, 2023
    Last Updated
    July 27, 2023
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05967650
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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]

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Bowel Diseases
    Keywords
    Hepatitis B vaccines

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HBV vaccination of Inflammatory bowel disease patients with stander regemin
    Arm Type
    Active Comparator
    Arm Description
    inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination st dose zero nd dose after 2 months rd dose after 6 months
    Arm Title
    HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin
    Arm Type
    Active Comparator
    Arm Description
    inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination st dose zero nd dose after 1months rd dose after 3 months
    Intervention Type
    Biological
    Intervention Name(s)
    standard hepatitis B vaccine
    Intervention Description
    IBD patients with negative HBV will be diveded in to two arms first arm vaccinated with standard HBV vaccine regemin( dose 0.2.6)
    Intervention Type
    Biological
    Intervention Name(s)
    accelerated HBV Vaccine
    Intervention Description
    IBD patients with negative HBV will be diveded in to two arms second arm vaccinated with accelerated HBV vaccine regemin( dose 1.2.3)
    Primary Outcome Measure Information:
    Title
    - efficacy of accelerated HBV vaccine regimen versus standard HBV vaccine regiment among IBD patients already receive treatment
    Description
    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
    Time Frame
    7 months
    Secondary Outcome Measure Information:
    Title
    frequency of IBD patients with negative HBs Ab
    Description
    All IBD patients at Alraghy hospital will be tested for HBsAg, HBcAb and HBsAb titre by IU
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria Sabry
    Phone
    01013501910
    Email
    mariasabry1997@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    bahaa os taha
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    lobna ah abdelwahed
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19923578
    Citation
    Abraham C, Cho JH. Inflammatory bowel disease. N Engl J Med. 2009 Nov 19;361(21):2066-78. doi: 10.1056/NEJMra0804647. No abstract available.
    Results Reference
    background
    PubMed Identifier
    35387455
    Citation
    Fabian O, Kamaradova K. Morphology of inflammatory bowel diseases (IBD). Cesk Patol. 2022 Spring;58(1):27-37.
    Results Reference
    background
    PubMed Identifier
    20567592
    Citation
    Molodecky NA, Kaplan GG. Environmental risk factors for inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2010 May;6(5):339-46.
    Results Reference
    background
    PubMed Identifier
    22001864
    Citation
    Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
    Results Reference
    background
    PubMed Identifier
    27793607
    Citation
    Kaplan GG, Ng SC. Understanding and Preventing the Global Increase of Inflammatory Bowel Disease. Gastroenterology. 2017 Feb;152(2):313-321.e2. doi: 10.1053/j.gastro.2016.10.020. Epub 2016 Oct 25. Erratum In: Gastroenterology. 2017 Jun;152(8):2084.
    Results Reference
    background
    PubMed Identifier
    36681203
    Citation
    Gholizadeh O, Akbarzadeh S, Moein M, Yasamineh S, Hosseini P, Afkhami H, Amini P, Dadashpour M, Tahavvori A, Eslami M, Hossein Taherian M, Poortahmasebi V. The role of non-coding RNAs in the diagnosis of different stages (HCC, CHB, OBI) of hepatitis B infection. Microb Pathog. 2023 Mar;176:105995. doi: 10.1016/j.micpath.2023.105995. Epub 2023 Jan 18.
    Results Reference
    background
    PubMed Identifier
    36899311
    Citation
    Azzam A, Khaled H, Elbohy OA, Mohamed SA, Mohamed SMH, Abdelkader AH, Ezzat AA, Elmowafy AOI, El-Emam OA, Awadalla M, Refaey N, Rizk SMA. Seroprevalence of hepatitis B virus surface antigen (HBsAg) in Egypt (2000-2022): a systematic review with meta-analysis. BMC Infect Dis. 2023 Mar 10;23(1):151. doi: 10.1186/s12879-023-08110-5.
    Results Reference
    background
    PubMed Identifier
    35179147
    Citation
    Fernandez Sanchez-Escalonilla S, Esparcia Rodriguez O, Lopez Canto S, Cantero Escribano JM, Molina Cabrero FJ, Gomez-Juarez Sango A, Garcia Guerrero J. [Vaccination against hepatitis B in patients with inflammatory bowel disease: immune response and associated factors.]. Rev Esp Salud Publica. 2022 Feb 18;96:e202202020. Spanish.
    Results Reference
    background
    PubMed Identifier
    34554119
    Citation
    Ridola L, Zullo A, Lagana B, Lorenzetti R, Migliore A, Pica R, Picchianti Diamanti A, Gigliucci G, Scolieri P, Bruzzese V. Hepatitis B (HBV) reactivation in patients receiving biologic therapy for chronic inflammatory diseases in clinical practice. Ann Ist Super Sanita. 2021 Jul-Sep;57(3):244-248. doi: 10.4415/ANN_21_03_08.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs