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

NCT02797782 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2017-06-20

No results posted yet for this study

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.

Conditions

  • Hepatitis B Vaccines

Interventions

OTHER

Detection of anti HBs antibody titer

All samples will be analyzed for anti HBs antibody titer using ELISA kits.

Sponsors & Collaborators

  • Sherief Abd-Elsalam

    lead OTHER

Principal Investigators

  • Asem Elfert, Prof · Hepatology and gastroenterology dept.-Tanta

  • Reham Elkhouly, Consultant · Division of Gastroenterology and Hepatology- Tanta

  • Rehab Badawi, Consultant · Hepatology and gastroenterology dept.-Tanta

  • Walaa Elkhalawany, Consultant · Hepatology and gastroenterology dept.-Tanta

  • Mona Watany, Consultant · clinical pathology dept.-Tanta

  • Sherief Abd-Elsalam, Consultant · Hepatology and gastroenterology dept.-Tanta

Eligibility

Min Age
20 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-12-31
Completion
2019-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02797782 on ClinicalTrials.gov