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

August 29, 2022 updated by: Mohamed Faik Hamed Ahmed, Assiut University
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

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmad Farooq Alsayed, Professor
  • Phone Number: +201020288660
  • Email: prof.a.f@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will provide clinical evaluation, laboratory investigations, and abdominal ultrasonography for every participant of the study. Clinical evaluation will include a detailed questionnaire concerning the potential risk factors of intra-familial transmission of HBV; it will include the kind of family relationship, demographic data, history of hepatitis B vaccination, and the potential routes of HBV transmission. The battery of laboratory work will include hepatitis B surface antigen (for diagnosis of infection), and titer of antibody to hepatitis B surface (for assessment of the immunologic status among non-infected subjects). In addition, liver chemistry panel will be performed for infected patients to help in the assessment of liver disease severity.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the frequency of intra-familial transmission of HBV; & trying to explore the potential risk factors of such a transmission.
Time Frame: Baseline.
Determine the frequency of intra-familial transmission of HBV; & trying to explore the potential risk factors of such a transmission.
Baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV.
Time Frame: Baseline.
To assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (ACTUAL)

September 1, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe