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Assessment of HBV Vaccine Immunity After 18 Years

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Medical Corps, Israel Defense Force.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT01590381
First received: May 1, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted

May 1, 2012
May 1, 2012
December 2011
January 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Assessment of HBV Vaccine Immunity After 18 Years
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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood samples from study subjects vaccinated at infancy, before and after booster dose.

Probability Sample

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.

Hepatitis b Vaccine
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
545
April 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact: Michael Hartal, MD +972-3-7374137 Mhuerta2@gmail.com
Israel
 
NCT01590381
IDF 1047-2011
No
Medical Corps, Israel Defense Force
Medical Corps, Israel Defense Force
Not Provided
Principal Investigator: Michael Hartal, MD International Diabetes Federation
Medical Corps, Israel Defense Force
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP