Clincosm LogoSign in Get a demo

Assessment of HBV Vaccine Immunity After 18 Years

Sponsor
Medical Corps, Israel Defense Force (Other)
Overall Status
Unknown status
CT.gov ID
NCT01590381
Collaborator
(none)
545
Enrollment
1
Location
16
Duration (Months)
34.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    545 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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.
    Study Start Date :
    Dec 1, 2011
    Anticipated Primary Completion Date :
    Jan 1, 2013
    Anticipated Study Completion Date :
    Apr 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 45 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Israeli Defense Forces Tel Aviv Israel

      Sponsors and Collaborators

      • Medical Corps, Israel Defense Force

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Medical Corps, Israel Defense Force
      ClinicalTrials.gov Identifier:
      NCT01590381
      Other Study ID Numbers:
      • IDF 1047-2011
      First Posted:
      May 2, 2012
      Last Update Posted:
      May 2, 2012
      Last Verified:
      May 1, 2012
      Additional relevant MeSH terms:
      Hepatitis B
      Hepatitis

      Study Results

      No Results Posted as of May 2, 2012