Improved Prevention of Perinatal Hepatitis B Transmission
The Employing of the Bio-Hep-B PreS1/PreS2/S Hepatitis B Virus (HBV) Vaccine in New Born Babies From HBV Positive Palestinian Mothers
1 other identifier
interventional
6,343
1 country
1
Brief Summary
Impaired activity of Natural Killer (NK) cells has been proposed as a mechanism contributing to viral persistence in Hepatitis C Virus (HCV) infection. NK cells display anti-fibrotic activities by killing activated hepatic stellate cells (HSCs) that have lost the self-recognition marker; Major Histocompatibility (MHC) class I. Determining the down-expressed genes on NK cells necessary for their anti-fibrotic activity was never studied previously. This will allow us to study their role fully in phagocytosis process as well as their interaction of HSCs and therefore manipulating these genes using molecular techniques. Exploring the cellular functions of these genes will highlight their involvement in the progression of liver fibrosis and could be used as a therapeutic tool for preventing the disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 28, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJune 17, 2010
January 1, 2010
6 months
May 25, 2010
June 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Co-infection with Hepatitis D and HIV.
3 month
Interventions
Sci B vac
Eligibility Criteria
You may qualify if:
- All Hepatitis B s Antigen (HBsAg) positive pregnant women attending the centers will be suggested to participate in the study and therefore provided with all information needed
You may not qualify if:
- Co-infection with HIV
- Mothers with immune suppression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Center
Jerusalem, 91120, Israel
Related Publications (1)
Safadi R, Khoury T, Saed N, Hakim M, Jamalia J, Nijim Y, Farah N, Nuser T, Natur N, Mahamid M, Amer J, Roppert PL, Gerlich WH, Glebe D. Efficacy of Birth Dose Vaccination in Preventing Mother-to-Child Transmission of Hepatitis B: A Randomized Controlled Trial Comparing Engerix-B and Sci-B-Vac. Vaccines (Basel). 2021 Apr 1;9(4):331. doi: 10.3390/vaccines9040331.
PMID: 33915943DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rifaat Safadi, M.D
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 28, 2010
Study Start
September 1, 2010
Primary Completion
March 1, 2011
Study Completion
September 1, 2013
Last Updated
June 17, 2010
Record last verified: 2010-01