Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Nile Delta of Egypt
NCT ID: NCT02797782
Last Updated: 2017-06-20
Study Results
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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UNKNOWN
200 participants
OBSERVATIONAL
2016-06-30
2019-03-31
Brief Summary
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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.
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Detailed Description
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In Egypt, the routine infant immunization for hepatitis B virus started in 1992, and was given at 2nd, 4th and 6th months of age. In the present study the investigators will investigate the long term efficacy of hepatitis B vaccination in young adults 20 to 22 years after the primary vaccination in Nile Delta of Egypt.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Interventions
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Detection of anti HBs antibody titer
All samples will be analyzed for anti HBs antibody titer using ELISA kits.
Eligibility Criteria
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Inclusion Criteria
* Administration of HBV vaccine during routine infant immunization (2nd, 4th, 6th months after birth)
Exclusion Criteria
* Treatment with immune-modulatory or immune-suppressive drugs
20 Years
22 Years
ALL
Yes
Sponsors
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Sherief Abd-Elsalam
OTHER
Responsible Party
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Sherief Abd-Elsalam
Consultant liver and GIT diseases- Tanta university hospital
Principal Investigators
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Asem Elfert, Prof
Role: PRINCIPAL_INVESTIGATOR
Hepatology and gastroenterology dept.-Tanta
Reham Elkhouly, Consultant
Role: STUDY_CHAIR
Division of Gastroenterology and Hepatology- Tanta
Rehab Badawi, Consultant
Role: STUDY_CHAIR
Hepatology and gastroenterology dept.-Tanta
Walaa Elkhalawany, Consultant
Role: STUDY_CHAIR
Hepatology and gastroenterology dept.-Tanta
Mona Watany, Consultant
Role: STUDY_CHAIR
clinical pathology dept.-Tanta
Sherief Abd-Elsalam, Consultant
Role: STUDY_CHAIR
Hepatology and gastroenterology dept.-Tanta
Locations
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Sherief Abd-Elsalam
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HBV vaccine
Identifier Type: -
Identifier Source: org_study_id
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