Intrafamilial Transmission of Hepatitis B Virus: Frequency, Risk Factors, and Role of Hepatitis B Vaccination

NCT ID: NCT05523921

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-01

Brief Summary

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The primary aim of the study is to accomplish two major tasks: the first is to determine the frequency of intra-familial transmission of HBV; the second is trying to explore the potential risk factors of such a transmission .As a secondary aim, immunologic status of the household contacts vaccinated for hepatitis B will be evaluated to assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV

Detailed Description

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Hepatitis B virus (HBV) infection is a global health issue; it is estimated that 257 million persons have chronic HBV (Asgeir et al., 2021). The major routes of HBV transmission include blood, sexual contact, vertical (from infected mothers to her children) and horizontal (between the spouses or children) transmission (Şükran et al., (2018). The household transmission of HBV is also a major health issue; it represents a challenge to the health system. Higher rates of HBV infection were reported among the household contacts of chronic HBV carriers; the prevalence of HBV infection among the family members of patients with chronic HBV can reach to 57%. Factors affecting the risk of transmission include socio-demographic status, family role (infected mothers increase the risk of transmission) and viral markers of the index case (Masomeh et al., 2016).The diagnosis of HBV infection is generally based on serological (hepatitis B surface antigen) and molecular assays (hepatitis B virus deoxyribonucleic acid) (Chen et al., 2017).Although the three-dose vaccination for hepatitis B provides more than 90% seroprotection rates (Van Den Ende C, et al, 2017); approximately 10% of vaccinated persons may be at risk of getting infected.

Available data about the current status of intra-familial transmission of HBV among our community members are lacking; we need to determine the magnitude of such a major public health problem

Conditions

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HBV Transmission

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* : The household contacts of patients with chronic HBV infection will be included in the study.

Exclusion Criteria

* Those with prior diagnosis of HBV infection following the date of the primary case infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Faik Hamed Ahmed

Mohamed Faik Hamed Ahmed

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohammed Faik Hamed, Resident

Role: CONTACT

+201148960065

Ahmad Farooq Alsayed, Professor

Role: CONTACT

+201020288660

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33925930/

.Asgeir J, Bitsatab M, Hailemichael D et al., (2021). Mother-to-Child Transmission of Hepatitis B Virus in Ethiopia. Vaccines, 9, 430.

http://www.nature.com/articles/s41598-017-00111-0

Chen E-Q, Feng S, Wang M, Liang L, Zhou L et al., (2017). Serum hepatitis B core-related antigen is a satisfactory surrogate marker of intrahepatic covalently closed circular DNA in chronic hepatitis B. Sci Rep; 7:173.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5563930/

Masomeh S, Mohammad B, Masoomeh Z et al., (2016). Intra-familial Transmission of Hepatitis B Virus Infection in Arak, Central Iran. Iran J Pathol; 11(4): 328 - 333

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3732666

Pournik O, Alavian S, Ghalichi L et al., (2013). Lower intrafamilial transmission rate of hepatitis B in patients with hepatitis d coinfection: a data-miningapproach. Hepat; 13(5).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2095015/

Şükran K (2018). Laboratory Diagnosis of HBV Viral Hepatitis: Chronic Hepatitis B. p 51-64

https://pubmed.ncbi.nlm.nih.gov/28573913/

Van Den Ende C, et al. The immunogenicity and safety of GSK's recombinant hepatitis B vaccine in adults: a systematic review of 30 years of experience. Expert Rev Vaccines. 2017 16(8):811-832.

Other Identifiers

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Transmission of HBV

Identifier Type: -

Identifier Source: org_study_id

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