Hepatitis b VaccineNCT01590381
Assessment of HBV Vaccine Immunity After 18 Years
An observational study of Hepatitis b Vaccine, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis b Vaccine
- How many people
- 545 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Soldiers born on or after January 1st, 1992
- Soldiers taking part in a medical training course
- Soldiers that signed an informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Israeli Defense Forces
Tel Aviv
Michael Hartal, MD, +972-3-7374137, Mhuerta2@gmail.com
About this study
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.
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.
Read the 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).
- Conditions
- Hepatitis b Vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| personnel in medical training - COURSE 1 | Not described | |
| personnel in medical training - COURSE 2 | Not described | |
| personnel in medical training - COURSE 3 | Not described | |
| personnel in medical training - COURSE 4 | Not described | |
| personnel in medical training - COURSE 5 | Not described | |
| personnel in medical training - COURSE 6 | Not described | |
| personnel in medical training - COURSE 7 | Not described | |
| personnel in medical training - COURSE 8 | Not described | |
| personnel in medical training - COURSE 9 | Not described | |
| personnel in medical training - COURSE 10 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis b VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 545 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Hartal, MD, Principal investigator, International Diabetes Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590381
- Sponsor's protocol ID
- IDF 1047-2011
- Status last verified
- May 2012
- First submitted
- 1 May 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01590381
- Acronym / sponsor ID
- IDF 1047-2011
- Conditions
- Hepatitis b Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 545 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Soldiers born on or after January 1st, 1992
- Soldiers taking part in a medical training course
- Soldiers that signed an informed consent form
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hartal, MD principal investigator
International Diabetes Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis b Vaccine, run by Medical Corps, Israel Defense Force at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Hartal, MD (+972-3-7374137, Mhuerta2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2012.