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Assessment of HBV Vaccine Immunity After 18 Years

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ClinicalTrials.gov Identifier: NCT01590381
Recruitment Status : Unknown
Verified May 2012 by Medical Corps, Israel Defense Force.
Recruitment status was:  Recruiting
First Posted : May 2, 2012
Last Update Posted : May 2, 2012
Sponsor:
Information provided by (Responsible Party):
Medical Corps, Israel Defense Force

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
Hepatitis b Vaccine

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
Estimated 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 : December 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Biospecimen Retention:   Samples Without DNA
blood samples from study subjects vaccinated at infancy, before and after booster dose.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590381


Contacts
Contact: Michael Hartal, MD +972-3-7374137 Mhuerta2@gmail.com

Locations
Israel
Israeli Defense Forces Recruiting
Tel Aviv, Israel
Contact: Michael Hartal, MD    +972-3-7374137    Mhuerta2@gmail.com   
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
Principal Investigator: Michael Hartal, MD International Diabetes Federation

Responsible Party: Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT01590381     History of Changes
Other Study ID Numbers: IDF 1047-2011
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human