Hepatitis BPhase 3NCT00291954
Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination
A Phase 3 study testing HB-AS02V and HBVAXPRO vaccine in people with Hepatitis B, run by Henogen at 25 sites in 3 countries.
Trial summary
Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- HB-AS02V and HBVAXPRO vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 25 sitesin 3 countries
- Study dates
- Mar 2006to Oct 2007
- Phase
- Phase 3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A male or female subject greater than or equal to 15 years of age at the time of study entry
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Seronegative for anti-HBc antibodies and for HBsAg at screening.
- Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
- Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
- The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
- Documented evidence of non-response to previous hepatitis B vaccination after at least one to maximum three months after the last vaccine dose.
Who cannot join
- Subject included on HN014/HBV-001 study. History of Hepatitis B infection Use of immunoglobulins within six months preceding the first study vaccination.
- Any confirmed or suspected human immunodeficiency virus (HIV) infection. Pregnant or lactating female
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
Belgium13 sites
O.L.Vrouwziekenhuis Aalst
Aalst, 9300
RHMS La Madeleine ATH
Ath, 7800
RHMS Clinique Louis Caty Baudour
Baudour, 7331
Cliniques universitaires Saint Luc
Brussels, 1200
CHU Brugmann (site V Horta) Service de néphrologie
Brussels, B-1020
ULB Hôpital Erasme Département de Néphrologie
Brussels
CHU Hôpital civil de
Charleroi, 6000
UZ AntwerpenDienst nefrologie
Edegem, B-2650
UZ Gent
Ghent, 9000
CHU Tivoli
La Louvière, 7100
UZ Gasthuisberg Leuven Nierziekten
Leuven, 3000
CHU Andre VESALE
Montigny-le-Tilleul, 6110
RHMS TournayService de néphrologie
Tournai, 7500
Czechia6 sites
Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
Hradec Králové, 581500 05
Dept. of Heamodialysis Hospital JihlavaVrchlického
Jihlava, 59586 33
Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
Olomouc, 6775 20
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
Ostrava - Poruba, 1790708 52
Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
Pardubice, 44532 03
Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
Sokolov, 1863356 01
Hungary6 sites
University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
Debrecen, .H-4012
Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
Eger, H-3300
Vaszary Kolos HospitalFresenius Dialysis Center
Esztergom, H-2500
Petz Aladár Teaching Hospital Vasvári
Győr, H-9023
Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
Hatvan, H-3000
Zala County HospitalII. Medical Department Nephrology Zrinyi
Zalaegerszeg, H-8900
About this study
Official title: A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1months to That of Aventis Pasteur MSD's Hepatitis B Given at 0, 1 Months in Pre-Dialysis, and Dialysis Patients Did Not Respond to Previous Hepatitis B Vaccination
Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.
Read the detailed description
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of these visits.
- Conditions
- Hepatitis B
- Being tested
- HB-AS02V, HBVAXPRO vaccine
- Keywords
- Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis hepatitis B infection
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-AS02VBiological
HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
HBVAXPRO vaccineBiological
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Henogen hepatitis B vaccine Receives: Biological: HB-AS02V |
| 2 | Active comparator | HBVAXPRO hepatitis B vaccine Receives: Biological: HBVAXPRO vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs seroprotection rate
Measured: Month 2
Secondary outcomes (7)
Anti-HBs Seroprotection rates for all subjects.
Measured: Months 0, 1 and 2
Anti-HBs Seropositivity rates for all subjects.
Measured: Months 0, 1 and 2
Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
Measured: Months 0, 1 and 2
Anti-HBs Geometric Mean Concentrations calculated for all subjects.
Measured: Months 0, 1 and 2
Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall
Measured: Month 0, 1 and 2
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall
Measured: Month 0, 1 and 2
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2
Measured: Month 0 to 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Investigators
- Christian Tielemans, MD, PhD, Principal investigator, ULB Hôpital Erasme Département de Néphrologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291954
- Sponsor's protocol ID
- HN017/HBV-003 (105762)
- Status last verified
- Aug 2008
- First submitted
- 14 Feb 2006
- Last updated
- 28 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1months to That of Aventis Pasteur MSD's Hepatitis B Given at 0, 1 Months in Pre-Dialysis, and Dialysis Patients Did Not Respond to Previous Hepatitis B Vaccination
- ClinicalTrials.gov ID
- NCT00291954
- Acronym / sponsor ID
- HN017/HBV-003 (105762)
- Conditions
- Hepatitis B
- Keywords
- Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis hepatitis B infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- HenogenIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 15 Feb 2006 (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.
Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.
Detailed description
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of these visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: HB-AS02VHenogen hepatitis B vaccine |
| 2 | Active comparator | Biological: HBVAXPRO vaccineHBVAXPRO hepatitis B vaccine |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- A male or female subject greater than or equal to 15 years of age at the time of study entry
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Seronegative for anti-HBc antibodies and for HBsAg at screening.
- Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
- Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
Key exclusion criteria (2 listed)
- Subject included on HN014/HBV-001 study. History of Hepatitis B infection Use of immunoglobulins within six months preceding the first study vaccination.
- Any confirmed or suspected human immunodeficiency virus (HIV) infection. Pregnant or lactating female
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 |
|---|---|---|
| HB-AS02VHB-AS02V (20µg HBsAg) will be administered at Month 0 and 1 | Biological | 1 |
| HBVAXPRO vaccineHBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1 | Biological | 2 |
Primary outcome
Anti-HBs seroprotection rate
Time frame: Month 2
7 secondary outcomes
Anti-HBs Seroprotection rates for all subjects.
Time frame: Months 0, 1 and 2
Anti-HBs Seropositivity rates for all subjects.
Time frame: Months 0, 1 and 2
Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects
Time frame: Months 0, 1 and 2
Anti-HBs Geometric Mean Concentrations calculated for all subjects.
Time frame: Months 0, 1 and 2
Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall
Time frame: Month 0, 1 and 2
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall
Time frame: Month 0, 1 and 2
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2
Time frame: Month 0 to 2
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 28 Aug 2008.
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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.
Christian Tielemans, MD, PhD principal investigator
ULB Hôpital Erasme Département de Néphrologie
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HB-AS02V and HBVAXPRO vaccine in people with Hepatitis B, run by Henogen at 25 sites in 3 countries.
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 7 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: finished, as of the sponsor's last update on 28 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Belgium, Czechia, Hungary. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anti-HBs seroprotection rate (time frame: Month 2). 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 28 Aug 2008.