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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02797782
Enrollment
200
Registered
2016-06-13
Start date
2016-06-30
Completion date
2019-03-31
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Vaccines

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.

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.

Interventions

OTHERDetection of anti HBs antibody titer

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

Sponsors

Sherief Abd-Elsalam
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 22 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of individuals with protective anti-HBs antibody titers1 yearNumber of individuals having protective anti-HBs antibody titers

Countries

Egypt

Contacts

Primary ContactSherief Abd-Elsalam, Consultant
sherif_tropical@yahoo.com00201095159522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026