xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05967650</url>
    </required_header>
    <id_info>
      <org_study_id>HBV vaccines in IBD patients</org_study_id>
      <nct_id>NCT05967650</nct_id>
    </id_info>
    <brief_title>Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients</brief_title>
    <official_title>Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal&#xD;
        tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect&#xD;
        young populations, altering their quality of life and increasing morbidity, compared to the&#xD;
        general population . The etiology and pathogenesis of IBD are still poorly understood.&#xD;
  &#xD;
        Inflammatory bowel disease (IBD) patients are at an increased risk of contracting and&#xD;
        developing complications from hepatitis B virus (HBV) due to their weakened immune systems&#xD;
        and frequent use of immunosuppressive medications. The traditional HBV vaccine regimen&#xD;
        requires three doses over six months to achieve full immunity, which can be challenging for&#xD;
        IBD patients who may have difficulty adhering to the schedule or may not respond well to the&#xD;
        vaccine&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal&#xD;
        tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect&#xD;
        young populations, altering their quality of life and increasing morbidity, compared to the&#xD;
        general population . The etiology and pathogenesis of IBD are still poorly understood. The&#xD;
        pathogenesis of IBD involves genetic factors and environmental factors . In Egypt, the&#xD;
        prevalence of IBD has been increasing in recent years.&#xD;
  &#xD;
        Patients with inflammatory bowel illnesses are more susceptible to viral infections. In&#xD;
        people with IBD, viral infections have emerged as a significant issue. Viral infections are&#xD;
        often difficult to identify and have a high morbidity and fatality rate.&#xD;
  &#xD;
        The hepatitis B virus is a widespread infection worldwide. HBV is a DNA virus of the&#xD;
        Hepadnaviridae family that is a significant cause of morbidity and mortality . Hepatitis B&#xD;
        virus (HBV) infection is a global health problem with a continuously increasing burden in&#xD;
        developing countries like Egypt.&#xD;
  &#xD;
        The prevalence of HBV in Egypt remains a significant public health concern, with a pooled&#xD;
        prevalence of 3.67%. However, the introduction of the HBV vaccination program in 1992 has led&#xD;
        to a decrease in prevalence among low-risk populations, with a pooled prevalence estimate of&#xD;
        1.93%. This highlights the importance of continued efforts to promote and expand HBV&#xD;
        vaccination programs in Egypt.Notably, children under 20 with a history of HBV vaccination in&#xD;
        infancy had the lowest prevalence of 0.69%, indicating the effectiveness of HBV vaccination&#xD;
        during infancy in providing adequate protection. This underscores the need for increasing&#xD;
        vaccination coverage among infants and young children in Egypt.However, the prevalence of HBV&#xD;
        in pregnant females was still high among low-risk groups, with a pooled prevalence of 2.9%.&#xD;
        This highlights the importance of targeted interventions to prevent mother-to-child&#xD;
        transmission of HBV, such as screening pregnant women for HBV and providing antiviral therapy&#xD;
        to those who test positive.Overall, while progress has been made in reducing the prevalence&#xD;
        of HBV in Egypt, continued efforts are needed to further decrease the burden of this disease&#xD;
        and prevent its transmission.&#xD;
  &#xD;
        Inflammatory bowel disease (IBD) patients are at an increased risk of contracting and&#xD;
        developing complications from hepatitis B virus (HBV) due to their weakened immune systems&#xD;
        and frequent use of immunosuppressive medications. The traditional HBV vaccine regimen&#xD;
        requires three doses over six months to achieve full immunity, which can be challenging for&#xD;
        IBD patients who may have difficulty adhering to the schedule or may not respond well to the&#xD;
        vaccine. An accelerated HBV vaccine regimen has been developed that allows for faster&#xD;
        immunity with fewer doses, but its efficacy in IBD patients to be investigated.[5]&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>- efficacy of accelerated HBV vaccine regimen versus standard HBV vaccine regiment among IBD patients already receive treatment</measure>
      <time_frame>7 months</time_frame>
      <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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>frequency of IBD patients with negative HBs Ab</measure>
      <time_frame>2 months</time_frame>
      <description>All IBD patients at Alraghy hospital will be tested for HBsAg, HBcAb and HBsAb titre by IU</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Inflammatory Bowel Diseases</condition>
    <arm_group>
      <arm_group_label>HBV vaccination of Inflammatory bowel disease patients with stander regemin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination&#xD;
  st dose zero&#xD;
  nd dose after 2 months&#xD;
  rd dose after 6 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination&#xD;
  st dose zero&#xD;
  nd dose after 1months&#xD;
  rd dose after 3 months</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>standard hepatitis B vaccine</intervention_name>
      <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)</description>
      <arm_group_label>HBV vaccination of Inflammatory bowel disease patients with stander regemin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>accelerated HBV Vaccine</intervention_name>
      <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)</description>
      <arm_group_label>HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  IBD patients with negative HBs Ag and HBsAb less than 10&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who refuse enter the study&#xD;
  &#xD;
            -  Patients who already have HBV infection&#xD;
  &#xD;
            -  Patients who had HBV vaccine recently&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>bahaa os taha</last_name>
      <role>Study Chair</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>lobna ah abdelwahed</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maria Sabry</last_name>
      <phone>01013501910</phone>
      <email>mariasabry1997@gmail.com</email>
    </overall_contact>
    <reference>
      <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.</citation>
      <PMID>19923578</PMID>
    </reference>
    <reference>
      <citation>Fabian O, Kamaradova K. Morphology of inflammatory bowel diseases (IBD). Cesk Patol. 2022 Spring;58(1):27-37.</citation>
      <PMID>35387455</PMID>
    </reference>
    <reference>
      <citation>Molodecky NA, Kaplan GG. Environmental risk factors for inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2010 May;6(5):339-46.</citation>
      <PMID>20567592</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>22001864</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27793607</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>36681203</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>36899311</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>35179147</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>34554119</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Maria Sabry</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <keyword>Hepatitis B vaccines</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hepatitis B</mesh_term>
      <mesh_term>Hepatitis</mesh_term>
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05967650
  org study id: HBV vaccines in IBD patients
  nct id: NCT05967650
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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
  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]
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: - efficacy of accelerated HBV vaccine regimen versus standard HBV vaccine regiment among IBD patients already receive treatment
  time frame: 7 months
  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
  measure: frequency of IBD patients with negative HBs Ab
  time frame: 2 months
  description: All IBD patients at Alraghy hospital will be tested for HBsAg, HBcAb and HBsAb titre by IU
  arm group label: HBV vaccination of Inflammatory bowel disease patients with stander regemin
  arm group type: Active Comparator
  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 group label: HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin
  arm group type: Active Comparator
  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: standard hepatitis B vaccine
  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)
  arm group label: HBV vaccination of Inflammatory bowel disease patients with stander regemin
  intervention type: Biological
  intervention name: accelerated HBV Vaccine
  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)
  arm group label: HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: bahaa os taha
  role: Study Chair
  affiliation: Assiut University
  last name: lobna ah abdelwahed
  role: Study Director
  affiliation: Assiut University
  last name: Maria Sabry
  phone: 01013501910
  email: mariasabry1997@gmail.com
  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.
  PMID: 19923578
  citation: Fabian O, Kamaradova K. Morphology of inflammatory bowel diseases (IBD). Cesk Patol. 2022 Spring;58(1):27-37.
  PMID: 35387455
  citation: Molodecky NA, Kaplan GG. Environmental risk factors for inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2010 May;6(5):339-46.
  PMID: 20567592
  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.
  PMID: 22001864
  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.
  PMID: 27793607
  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.
  PMID: 36681203
  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.
  PMID: 36899311
  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.
  PMID: 35179147
  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.
  PMID: 34554119
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Maria Sabry
  investigator title: Doctor
  mesh term: Hepatitis B
  mesh term: Hepatitis
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases
  mesh term: Vaccines