This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 63 of 362 for:    hepatitis b | Recruiting, Not yet recruiting, Available 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 2017 by Sherief Abd-Elsalam, Tanta University
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University
ClinicalTrials.gov Identifier:
NCT02797782
First received: June 8, 2016
Last updated: June 17, 2017
Last verified: June 2017
  Purpose

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 Sherief Abd-Elsalam, Tanta University:

Primary Outcome Measures:
  • Number of individuals with protective anti-HBs antibody titers [ Time Frame: 1 year ]
    Number of individuals having protective anti-HBs antibody titers


Estimated Enrollment: 200
Study Start Date: June 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (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.

  Eligibility

Ages Eligible for Study:   20 Years to 22 Years   (Adult)
Sexes Eligible for Study:   All
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)
Criteria

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 ClinicalTrials.gov identifier: NCT02797782

Contacts
Contact: Sherief Abd-Elsalam, Consultant 00201095159522 sherif_tropical@yahoo.com

Locations
Egypt
Sherief Abd-Elsalam Recruiting
Cairo, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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
ClinicalTrials.gov Identifier: NCT02797782     History of Changes
Other Study ID Numbers: HBV vaccine
Study First Received: June 8, 2016
Last Updated: June 17, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hepatitis
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
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017