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

Hepatitis B Vaccines Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02797782
• Other study ID #: HBV vaccine
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2016
• Last updated: June 17, 2017
• Start date: June 2016
• Est. completion date: March 2019

Study information

• Verified date: June 2017
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, Consultant
• Phone: 00201095159522
• Email: sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccines

Intervention

Other:
• Detection of anti HBs antibody titer
All samples will be analyzed for anti HBs antibody titer using ELISA kits.

Locations

Country	Name	City	State
Egypt	Sherief Abd-Elsalam	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of individuals with protective anti-HBs antibody titers	Number of individuals having protective anti-HBs antibody titers	1 year