Clinical trial NCT02797782: Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Nile Delta of Egypt
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B Vaccines
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Age 20-22 years
* Administration of HBV vaccine during routine infant immunization (2nd, 4th, 6th months after birth)

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.

Eligibility 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

Primary outcomes:
measure: Number of individuals with protective anti-HBs antibody titers
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Asem Elfert, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Gastroenterology and Hepatology- Tanta
name: Reham Elkhouly, Consultant
role: STUDY_CHAIR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Rehab Badawi, Consultant
role: STUDY_CHAIR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Walaa Elkhalawany, Consultant
role: STUDY_CHAIR
affiliation: clinical pathology dept.-Tanta
name: Mona Watany, Consultant
role: STUDY_CHAIR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Sherief Abd-Elsalam, Consultant
role: STUDY_CHAIR
References: