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
  Purpose

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
Hepatitis b Vaccine

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Medical Corps, Israel Defense Force:

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 545
Study Start Date: December 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT01590381     History of Changes
Other Study ID Numbers: IDF 1047-2011
Study First Received: May 1, 2012
Last Updated: May 1, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 22, 2014