- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05523921
Intrafamilial Transmission of Hepatitis B Virus: Frequency, Risk Factors, and Role of Hepatitis B Vaccination
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohammed Faik Hamed, Resident
- Phone Number: +201148960065
- Email: mohammadfaik9523@gmail.com
Study Contact Backup
- Name: Ahmad Farooq Alsayed, Professor
- Phone Number: +201020288660
- Email: prof.a.f@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Publications and helpful links
Helpful Links
- .Asgeir J, Bitsatab M, Hailemichael D et al., (2021). Mother-to-Child Transmission of Hepatitis B Virus in Ethiopia. Vaccines, 9, 430.
- 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.
- 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
- 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).
- Şükran K (2018). Laboratory Diagnosis of HBV Viral Hepatitis: Chronic Hepatitis B. p 51-64
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Transmission of HBV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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