Assessment of HBV Vaccine Immunity After 18 Years

Hepatitis b Vaccine Clinical Trial

Official title:

Assessment of the Immune Status of New Health Care Workers in the Israel Defense Forces (IDF) Vaccinated in Infancy Against Hepatitis B Virus (HBV), Before and After a Booster Dose.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01590381
• Other study ID #: IDF 1047-2011
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2012
• Last updated: May 1, 2012
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: May 2012
• Source: Medical Corps, Israel Defense Force
• Contact: Michael Hartal, MD
• Phone: +972-3-7374137
• Email: Mhuerta2[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess HBV immunity and institute policy regarding the Hepatitis B vaccination practices in the IDF among a cohort that was vaccinated during infancy.

Description:

The study population will consist of both males and females who were born after January 1st 1992, who are in medical training at the Medical Corps Training Base. Demographic information will be obtained through a questionnaire given to the soldiers in the study , as well as the IDF computerized personnel information database.

This study is designed to determine HBV vaccination policy among new HCWs in the IDF, who were vaccinated during infancy. This population was recruited to the IDF since the second half of 2010. Therefore, it is necessary to conduct this study on new HCWs that will be receiving the routine HBV vaccination and that will be at risk for HBV infection in the future due to their occupation in the army (HCWs, etc).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 545
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Soldiers born on or after January 1st, 1992

2. Soldiers taking part in a medical training course

3. Soldiers that signed an informed consent form

Exclusion Criteria:

1. Born before January 1st, 1992

2. Soldiers with previous known infection with HBV

3. Soldiers with documented evidence of immunity against HBV

4. Soldiers that refuse to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis b Vaccine

Locations

Country	Name	City	State
Israel	Israeli Defense Forces	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel,