Assessment of HBV Vaccine Immunity After 18 Years
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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. |
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 |
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.
Inclusion Criteria:
- Soldiers born on or after January 1st, 1992
- Soldiers taking part in a medical training course
- Soldiers that signed an informed consent form
Exclusion Criteria:
- Born before January 1st, 1992
- Soldiers with previous known infection with HBV
- Soldiers with documented evidence of immunity against HBV
- Soldiers that refuse to participate in the study
Contacts and Locations| Contact: Michael Hartal, MD | +972-3-7374137 | Mhuerta2@gmail.com |
| Israel | |
| Israeli Defense Forces | Recruiting |
| Tel Aviv, Israel | |
| Contact: Michael Hartal, MD +972-3-7374137 Mhuerta2@gmail.com | |
| Principal Investigator: | Michael Hartal, MD | IDF |
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 June 17, 2013