Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Nile Delta of Egypt
1 other identifier
observational
200
1 country
1
Brief Summary
More than two billion individuals have serological evidence of hepatitis B virus (HBV) infection worldwide. Of these, 240 million are chronic carriers and approximately 786,000 hepatitis B related deaths occur annually. Currently available hepatitis B vaccines are extremely safe and have an efficacy of \>90 percent against all HBV serotypes and genotypes. Thus, HBV infection can potentially be eradicated through global vaccination. A positive immune response to the vaccine is defined as the development of hepatitis B surface antibody (anti-HBs) at a titer of \>10 mIU/mL. Although anti-HBs titers decrease with time, the duration of protection is long. Protection has been estimated to persist for up to 22 years after the primary vaccination schedule. Protection from clinical disease, despite declining or even undetectable anti-HBs levels, is probably due to the priming of memory cells, which are capable of eliciting an anamnestic response when challenged. This is supported by the rapid increases in anti-HBs titers in previously vaccinated individuals who administered booster injections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
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
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedJune 20, 2017
June 1, 2017
2.5 years
June 8, 2016
June 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of individuals with protective anti-HBs antibody titers
Number of individuals having protective anti-HBs antibody titers
1 year
Interventions
All samples will be analyzed for anti HBs antibody titer using ELISA kits.
Eligibility Criteria
* Age 20-22 years * Administration of HBV vaccine during routine infant immunization (2nd, 4th, 6th months after birth)
You may qualify if:
- Age 20-22 years
- Administration of HBV vaccine during routine infant immunization (2nd, 4th, 6th months after birth)
You may not qualify if:
- Overt co-morbid condition
- Treatment with immune-modulatory or immune-suppressive drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sherief Abd-Elsalam
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asem Elfert, Prof
Hepatology and gastroenterology dept.-Tanta
- STUDY CHAIR
Reham Elkhouly, Consultant
Division of Gastroenterology and Hepatology- Tanta
- STUDY CHAIR
Rehab Badawi, Consultant
Hepatology and gastroenterology dept.-Tanta
- STUDY CHAIR
Walaa Elkhalawany, Consultant
Hepatology and gastroenterology dept.-Tanta
- STUDY CHAIR
Mona Watany, Consultant
clinical pathology dept.-Tanta
- STUDY CHAIR
Sherief Abd-Elsalam, Consultant
Hepatology and gastroenterology dept.-Tanta
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant liver and GIT diseases- Tanta university hospital
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 13, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2018
Study Completion
March 1, 2019
Last Updated
June 20, 2017
Record last verified: 2017-06