NCT05967650

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 8, 2023

Last Update Submit

July 27, 2023

Conditions

Inflammatory Bowel Diseases

Keywords

Hepatitis B vaccines

Outcome Measures

Primary Outcomes (1)

  • - 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

    7 months

Secondary Outcomes (1)

  • frequency of IBD patients with negative HBs Ab

    2 months

Study Arms (2)

HBV vaccination of Inflammatory bowel disease patients with stander regemin

ACTIVE COMPARATOR

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

HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin

ACTIVE COMPARATOR

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

Interventions

standard hepatitis B vaccineBIOLOGICAL

IBD patients with negative HBV will be diveded in to two arms first arm vaccinated with standard HBV vaccine regemin( dose 0.2.6)

HBV vaccination of Inflammatory bowel disease patients with stander regemin
accelerated HBV VaccineBIOLOGICAL

IBD patients with negative HBV will be diveded in to two arms second arm vaccinated with accelerated HBV vaccine regemin( dose 1.2.3)

HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IBD patients with negative HBs Ag and HBsAb less than 10

You may not qualify if:

  • Patients who refuse enter the study
  • Patients who already have HBV infection
  • Patients who had HBV vaccine recently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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: 19923578BACKGROUND

  • Fabian O, Kamaradova K. Morphology of inflammatory bowel diseases (IBD). Cesk Patol. 2022 Spring;58(1):27-37.

    PMID: 35387455BACKGROUND

  • Molodecky NA, Kaplan GG. Environmental risk factors for inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2010 May;6(5):339-46.

    PMID: 20567592BACKGROUND

  • 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: 22001864BACKGROUND

  • 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.

    PMID: 27793607BACKGROUND

  • 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: 36681203BACKGROUND

  • 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: 36899311BACKGROUND

  • 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: 35179147BACKGROUND

  • 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: 34554119BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel DiseasesHepatitis B

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver Diseases

Study Officials

  • bahaa os taha

    Assiut University

    STUDY CHAIR

  • lobna ah abdelwahed

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Maria Sabry

CONTACT

01013501910mariasabry1997@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 8, 2023

First Posted

August 1, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

August 1, 2023

Record last verified: 2023-07