Inflammatory Bowel DiseaseHBV VIPNCT01531075
Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease
A study testing ENGERIX-B (HBV Vaccine) and Sci-B-Vac in people with Inflammatory Bowel Disease, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- ENGERIX-B (HBV Vaccine) and Sci-B-Vac
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Aug 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female ≥ 18 years of age
- Evidence of IBD as diagnosed by clinical, laboratory imaging and endoscopic criteria.
- Treated with at least one immunosuppressive medication at the time of study initiation
- Provided written informed consent.
Who cannot join
- Pregnant women
- Diagnosis of chronic viral hepatitis B
- Any major acute medical event in the 30 days prior to recruitment that necessitated hospitalization ( acute myocardial infarction, CVA, pulmonary emboli, sepsis, major trauma)
- Any other chronic inflammatory condition not related to IBD ( connective tissue disease, Chronic liver disease, COPD, poorly controlled diabetes mellitus)
- Active hematologic or oncologic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases
The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- ENGERIX-B (HBV Vaccine), Sci-B-Vac
- Keywords
- HBV, Inflammatory bowel disease, immunosuppressor
- Medical subject headings
- Inflammatory Bowel Diseases, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENGERIX-B (HBV Vaccine)Biological
Also called ENGERIX-B
ENGERIX-B (Hepatitis B Vaccine) 20 mcg, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
Sci-B-VacBiological
Sci-B-Vac (Hepatitis B Vaccine) 10 μg/ml, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
| Study group | Role | What they receive |
|---|---|---|
| ENGERIX-B | Experimental | Not described Receives: Biological: ENGERIX-B (HBV Vaccine) |
| Sci-B-Vac | Experimental | Not described Receives: Biological: Sci-B-Vac |
What is being measured
The primary outcome is the main question the study is designed to answer.
protective level of anti HBs antibodies
Antibody titer >10 IU/ml 30 days following last vaccine dose will be considered protective.
In the work done by Altunoz et al., titer rate below 10 IU was observed in 40% of the patients, while 40% of the patients achieved a rate of above 100 IU. Therefore, we can estimate that the geometric mean of distribution is approx. 50 IU. A sample size of 37 patients in each group achieves a power of 80% to detect a ratio above 1.37 between the two vaccinated groups.
Measured: 1 month after the last does of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ohad Etzion, Soroka University Medical Center
- Investigators
- Ohad Etzion, MD, Principal investigator, Soroka UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531075
- Sponsor's protocol ID
- sor026511ctil
- Acronym
- HBV VIP
- Status last verified
- Apr 2020
- First submitted
- 8 Feb 2012
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT01531075
- Acronym / sponsor ID
- HBV VIP / sor026511ctil
- Conditions
- Inflammatory Bowel Disease
- Keywords
- HBV, Inflammatory bowel disease, immunosuppressor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Feb 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 objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENGERIX-B | Experimental | Biological: ENGERIX-B (HBV Vaccine) |
| Sci-B-Vac | Experimental | Biological: Sci-B-Vac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male/female ≥ 18 years of age
- Evidence of IBD as diagnosed by clinical, laboratory imaging and endoscopic criteria.
- Treated with at least one immunosuppressive medication at the time of study initiation
- Provided written informed consent.
Key exclusion criteria (5 listed)
- Pregnant women
- Diagnosis of chronic viral hepatitis B
- Any major acute medical event in the 30 days prior to recruitment that necessitated hospitalization ( acute myocardial infarction, CVA, pulmonary emboli, sepsis, major trauma)
- Any other chronic inflammatory condition not related to IBD ( connective tissue disease, Chronic liver disease, COPD, poorly controlled diabetes mellitus)
- Active hematologic or oncologic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENGERIX-B (HBV Vaccine)Also: ENGERIX-BENGERIX-B (Hepatitis B Vaccine) 20 mcg, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule. | Biological | ENGERIX-B |
| Sci-B-VacSci-B-Vac (Hepatitis B Vaccine) 10 μg/ml, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule. | Biological | Sci-B-Vac |
Primary outcome
protective level of anti HBs antibodies
Time frame: 1 month after the last does of vaccine
Antibody titer >10 IU/ml 30 days following last vaccine dose will be considered protective. In the work done by Altunoz et al., titer rate below 10 IU was observed in 40% of the patients, while 40% of the patients achieved a rate of above 100 IU. Therefore, we can estimate that the geometric mean of distribution is approx. 50 IU. A sample size of 37 patients in each group achieves a power of 80% to detect a ratio above 1.37 between the two vaccinated groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
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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.
Ohad Etzion, MD principal investigator
Soroka UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENGERIX-B (HBV Vaccine) and Sci-B-Vac in people with Inflammatory Bowel Disease, run by Soroka University Medical Center 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 21 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
protective level of anti HBs antibodies (time frame: 1 month after the last does of vaccine). It is what the study was designed to measure, not a finding.
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 21 Apr 2020.