Assessment of HBV Vaccine Immunity After 18 Years

May 1, 2012 updated by: Medical Corps, Israel Defense Force

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.

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.

Study Overview

Status

Unknown

Conditions

Detailed 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).

Study Type

Observational

Enrollment (Anticipated)

545

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Israeli Defense Forces
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
personnel in medical training - COURSE 1
personnel in medical training - COURSE 2
personnel in medical training - COURSE 3
personnel in medical training - COURSE 4
personnel in medical training - COURSE 5
personnel in medical training - COURSE 6
personnel in medical training - COURSE 7
personnel in medical training - COURSE 8
personnel in medical training - COURSE 9
personnel in medical training - COURSE 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Corps, Israel Defense Force

Investigators

  • Principal Investigator: Michael Hartal, MD, International Diabetes Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

May 1, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 2, 2012

Study Record Updates

Last Update Posted (Estimate)

May 2, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDF 1047-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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