Celiac DiseaseNCT00739128
Response to Hepatitis B Vaccine in Celiac Disease Patients
A study testing hepatitis B vaccine (EngerixB) in people with Celiac Disease, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Celiac Disease
- What is being tested?
- hepatitis B vaccine (EngerixB)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to Mar 2011
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy.
- Completion of the IM HBV vaccine series in infancy.
- HBsAb titer of ≤10mIU/mL at the time of enrollment.
Who cannot join
- Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathiopurine, 6-MP, steroids).
- Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intradermal Immunization Against Hepatitis B Virus in Celiac Disease- a Randomized Controlled Trial
Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series via a different route of administration (into the skin rather than the muscle) results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series into the skin or to the muscle. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.
- Conditions
- Celiac Disease
- Being tested
- hepatitis B vaccine (EngerixB)
- Keywords
- celiac disease, hepatitis B vaccine
- Medical subject headings
- Celiac Disease, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis B vaccine (EngerixB)Biological
Also called EngerixB, GSK
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscular at zero, one and six months intervals
hepatitis B vaccine (EngerixB)Biological
Also called (EngerixB, GSK)
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intradermally in the deltoid region at zero, one and six months intervals
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intramuscular route Receives: Biological: hepatitis B vaccine (EngerixB) |
| 2 | Active comparator | celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intradermal route Receives: Biological: hepatitis B vaccine (EngerixB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The primary endpoint of the study will be comparison of the geometric mean titers of anti-HBs between the intradermal and the intramuscular groups.
Measured: two years
Secondary outcomes (1)
1. Rate of responders four weeks after the completion of the series 2. Rate and characteristics of adverse drug reactions 3. Numerical increase in the antibodies titer before and after vaccination 4. Rate of responders in the cross over phase
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startFeb 2009
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Believed that a better study was to compare the response to engerix B vs Sci-B-Vac vaccine in this patient group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Maskit Bar Meir, MD, Principal investigator, Shaheed Ziaur Rahman Medical CollegeAri Silbermintz, Principal investigator, Shaheed Ziaur Rahman Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739128
- Sponsor's protocol ID
- 15363.ct.il
- Status last verified
- Apr 2011
- First submitted
- 20 Aug 2008
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradermal Immunization Against Hepatitis B Virus in Celiac Disease- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00739128
- Acronym / sponsor ID
- 15363.ct.il
- Conditions
- Celiac Disease
- Keywords
- celiac disease, hepatitis B vaccine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Believed that a better study was to compare the response to engerix B vs Sci-B-Vac vaccine in this patient group.
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Aug 2008 (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.
Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series via a different route of administration (into the skin rather than the muscle) results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series into the skin or to the muscle. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: hepatitis B vaccine (EngerixB)celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intramuscular route |
| 2 | Active comparator | Biological: hepatitis B vaccine (EngerixB)celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intradermal route |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy.
- Completion of the IM HBV vaccine series in infancy.
- HBsAb titer of ≤10mIU/mL at the time of enrollment.
Key exclusion criteria (2 listed)
- Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathiopurine, 6-MP, steroids).
- Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
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 |
|---|---|---|
| hepatitis B vaccine (EngerixB)Also: EngerixB, GSKA dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscular at zero, one and six months intervals | Biological | 1 |
| hepatitis B vaccine (EngerixB)Also: (EngerixB, GSK)A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intradermally in the deltoid region at zero, one and six months intervals | Biological | 2 |
Primary outcome
1. The primary endpoint of the study will be comparison of the geometric mean titers of anti-HBs between the intradermal and the intramuscular groups.
Time frame: two years
1 secondary outcome
1. Rate of responders four weeks after the completion of the series 2. Rate and characteristics of adverse drug reactions 3. Numerical increase in the antibodies titer before and after vaccination 4. Rate of responders in the cross over phase
Time frame: two years
Results and safety
The study was stopped early (reason given: Believed that a better study was to compare the response to engerix B vs Sci-B-Vac vaccine in this patient group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
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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.
Maskit Bar Meir, MD principal investigator
Shaheed Ziaur Rahman Medical College
Ari Silbermintz principal investigator
Shaheed Ziaur Rahman Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hepatitis B vaccine (EngerixB) in people with Celiac Disease, run by Shaare Zedek 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Apr 2011. 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 was stopped early (reason given: Believed that a better study was to compare the response to engerix B vs Sci-B-Vac vaccine in this patient group.). Results are not available in the source record.
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?
1. The primary endpoint of the study will be comparison of the geometric mean titers of anti-HBs between the intradermal and the intramuscular groups. (time frame: two years). 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 15 Apr 2011.