Celiac DiseaseNCT01159457
Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients
A study testing Hepatitis B vaccination (Sci-B-Vac) and Hepatitis B vaccination (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 to 20 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Hepatitis B vaccination (Sci-B-Vac) and Hepatitis B vaccination (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
- Apr 2011to Jan 2013
- 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 to 20 years
- All sexes
- No healthy volunteers
- Child, 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. azathioprine, 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.
Israel1 site, 1 recruiting
- Recruiting
SZMC
Jerusalem
Merav Heshin, MD, 0508685702, meravheshin@gmail.com
Lena Rachman, MD, 0508685338, jryelanar@gmail.com
About this study
Official title: Engerix B Versus Sci-B-Vac Immunization in a Celiac Population of Non-responders to Primary Hepatitis B Immunization Series - 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 with a different vaccine, Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.. 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 vaccination (Sci-B-Vac), Hepatitis B vaccination (EngerixB)
- Keywords
- Celiac Disease, Hepatitis B vaccination
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B vaccination (Sci-B-Vac)Biological
A dose of 5mcg (0.5 ml) (up to 10yr old) and 10mcg (1.0 ml)(above 10yr old) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
Hepatitis B vaccination (EngerixB)Biological
Also called GSK
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly 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 Sci-B-Vac vaccination series Receives: Biological: Hepatitis B vaccination (Sci-B-Vac) |
| 2 | Active comparator | celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series Receives: Biological: Hepatitis B vaccination (EngerixB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group
Measured: two years
Secondary outcomes (6)
Rate of responders four weeks after the completion of the series
Measured: two years
Rate and characteristics of adverse drug reactions
Measured: two years
Numerical increase in the antibodies titer before and after vaccination
Measured: two years
Rate of responders in the cross over phase.
Measured: two years
Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response
Measured: two years
Association between genetic make-up and vaccine response
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 posted9 Jul 2010 (estimated)
- Study startApr 2011
- Primary completionJun 2012 (estimated)
- Study completionJan 2013 (estimated)
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
- Lena Rachman, MD, Principal investigator, Shaheed Ziaur Rahman Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159457
- Sponsor's protocol ID
- 15364.ct.il
- Status last verified
- Apr 2011
- First submitted
- 8 Jul 2010
- Last updated
- 15 Apr 2011
- Results posted
- 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
- Engerix B Versus Sci-B-Vac Immunization in a Celiac Population of Non-responders to Primary Hepatitis B Immunization Series - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01159457
- Acronym / sponsor ID
- 15364.ct.il
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Hepatitis B vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 9 Jul 2010 (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 with a different vaccine, Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.. 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 vaccination (Sci-B-Vac)celiac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series |
| 2 | Active comparator | Biological: Hepatitis B vaccination (EngerixB)celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series |
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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. azathioprine, 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 vaccination (Sci-B-Vac)A dose of 5mcg (0.5 ml) (up to 10yr old) and 10mcg (1.0 ml)(above 10yr old) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals | Biological | 1 |
| Hepatitis B vaccination (EngerixB)Also: GSKA dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals | Biological | 2 |
Primary outcome
Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group
Time frame: two years
6 secondary outcomes
Rate of responders four weeks after the completion of the series
Time frame: two years
Rate and characteristics of adverse drug reactions
Time frame: two years
Numerical increase in the antibodies titer before and after vaccination
Time frame: two years
Rate of responders in the cross over phase.
Time frame: two years
Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response
Time frame: two years
Association between genetic make-up and vaccine response
Time frame: two years
Results and safety
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.
Lena Rachman, MD 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 vaccination (Sci-B-Vac) and Hepatitis B vaccination (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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merav Heshin, MD (0508685702, meravheshin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group (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.