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

NCT ID: NCT05967650

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-10-01

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]

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

standard hepatitis B vaccine

Intervention Type: BIOLOGICAL

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 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

Group Type: ACTIVE_COMPARATOR

accelerated HBV Vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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)

Intervention Type: 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)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Maria Sabry

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

bahaa os taha

Role: STUDY_CHAIR

Assiut University

lobna ah abdelwahed

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Maria Sabry

Role: CONTACT

mariasabry1997@gmail.com

01013501910

References

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Reference Type: BACKGROUND

PMID: 19923578 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 35387455 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 20567592 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22001864 (View on PubMed)

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.

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PMID: 27793607 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 36681203 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36899311 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35179147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34554119 (View on PubMed)

Other Identifiers

HBV vaccines in IBD patients

Identifier Type: -

Identifier Source: org_study_id