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Trial record 122 of 514 for:    hepatitis b | Open Studies

Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Nile Delta of Egypt

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University Identifier:
First received: June 8, 2016
Last updated: June 10, 2016
Last verified: June 2016

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.

Condition Intervention
Hepatitis B Vaccines
Other: Detection of anti HBs antibody titer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Young Adults 20-22 Years After the Primary Vaccination in Nile Delta of Egypt

Resource links provided by NLM:

Further study details as provided by Tanta University:

Primary Outcome Measures:
  • Number of individuals with protective anti-HBs antibody titers [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: June 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Detection of anti HBs antibody titer
    All samples will be analyzed for anti HBs antibody titer using ELISA kits.
Detailed Description:

A significant proportion of the vaccinated population loses both the protective levels of anti-HBs and an anamnestic response. Recommendations for booster vaccination have been proposed in a European consensus statement. Countries like the Netherlands, Germany, Spain, France and Belgium recommend a booster dose depending on the post-vaccination anti-HBs titer. In the UK, a single booster dose is recommended five years after primary vaccination.

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.


Ages Eligible for Study:   20 Years to 22 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • Age 20-22 years
  • Administration of HBV vaccine during routine infant immunization (2nd, 4th, 6th months after birth)

Inclusion Criteria:

  • Age 20-22 years
  • Administration of HBV vaccine during routine infant immunization (2nd, 4th, 6th months after birth)

Exclusion Criteria:

  • Overt co-morbid condition
  • Treatment with immune-modulatory or immune-suppressive drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02797782

Contact: Sherief Abd-Elsalam, Consultant 00201095159522

Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794   
Sponsors and Collaborators
Sherief Abd-Elsalam
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
  More Information

Responsible Party: Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University Identifier: NCT02797782     History of Changes
Other Study ID Numbers: HBV vaccine 
Study First Received: June 8, 2016
Last Updated: June 10, 2016
Health Authority: Egypt: Ministry of Higher Education
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on October 25, 2016