Hepatitis BPhase 3NCT00291941
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
A Phase 3 study testing Henogen HBV vaccine and FENDRIX in people with Hepatitis B, run by Henogen at 24 sites in 3 countries.
Trial summary
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course. 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?
- Henogen HBV vaccine and FENDRIX
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Feb 2006to Mar 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 15 years of age or older at the time of the study entry.
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
- Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
- Non-childbearing potential female
Who cannot join
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Use of any registered vaccine within 7 days before the first dose of study vaccine.
- Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
- History of hepatitis B infection.
- Known exposure to hepatitis B virus within 6 months.
- Use of immunoglobulins within six months preceding the first study vaccination.
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- Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
- Any confirmed or suspected human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature < 37.5°C (or 37 °C in Czech Republic).
- Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic).
- Pregnant or lactating female
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
Belgium14 sites
O.L.Vrouwziekenhuis Aalst
Aalst, 9300
RHMS La Madeleine ATH
Ath, 7800
RHMS Clinique Louis Caty Baudour
Baudour, 7331
AZ -VUB Dienst Nefrologie
Brussels, 1090
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
Czechia5 sites
Dept. of Heamodialysis Hospital JihlavaVrchlického
Jihlava, 59586 33
Regional Hospital Liberec
Liberec, 46063
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
Ostrava - Poruba, 1790708 52
Dept. of Internal Medicine StrahovSermirska 5
Prague, 169 00
Masaryk´s Hospital Socialni pece 3316/12A
Ústí nad Labem, 401 13
Hungary5 sites
St. Rókus Hospital
Budapest, 1085
St. István Hospital
Budapest, 1096
Petz Aladár Teaching Hospital Vasvári
Győr, H-9023
Pest County Flór Ferenc Hospital
Kistarcsa, 2143
Vas and Szombathely County Markusovszky Hospital
Szombathely, 9700
About this study
Official title: A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive.
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.
Read the detailed description
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.
- Conditions
- Hepatitis B
- Being tested
- Henogen HBV vaccine, FENDRIX
- Keywords
- Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Henogen HBV vaccineBiological
20µg, Month 0, 2 and 6
FENDRIXBiological
20 µg,Months 0, 1, 2 and 6
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Henogen HB vaccine Receives: Biological: Henogen HBV vaccine |
| 2 | Active comparator | Fendrix vaccine Receives: Biological: FENDRIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs seroprotection rate at Month 2.
Measured: Month 0 and 2
Secondary outcomes (10)
Anti-HBs antibody concentrations
Measured: Months 0, 1, 2, 3, 6 and 7
Anti-HBs seroprotection rates for all subjects.
Measured: Months 0, 1, 2, 3, 6 and 7
Anti-HBs seropositivity rates for all subjects
Measured: Months 0, 1, 2, 3, 6 and 7
Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects.
Measured: Months 0, 1, 2, 3, 6 and 7
Anti-HBs geometric mean concentrations calculated for all subjects.
Measured: Months 0, 1, 2, 3, 6 and 7
Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group.
Measured: Months 0 and 7
Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group.
Measured: Month 0 and 7
Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall.
Measured: Month 0, 1, 2, 3, 6 and 7
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall.
Measured: Month 0, 1, 2, 3, 6 and 7
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7.
Measured: Month 0 to 7
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 startFeb 2006
- Primary completionMar 2007
- Study completionMar 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
- 300 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
- NCT00291941
- Sponsor's protocol ID
- HN014/HBV-001 (105757)
- 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, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive.
- ClinicalTrials.gov ID
- NCT00291941
- Acronym / sponsor ID
- HN014/HBV-001 (105757)
- Conditions
- Hepatitis B
- Keywords
- Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- HenogenIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 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.
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.
Detailed description
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 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: Henogen HBV vaccineHenogen HB vaccine |
| 2 | Active comparator | Biological: FENDRIXFendrix vaccine |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A male or female subject 15 years of age or older at the time of the study entry.
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
- Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
- Non-childbearing potential female
Key exclusion criteria (13 listed)
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Use of any registered vaccine within 7 days before the first dose of study vaccine.
- Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
- History of hepatitis B infection.
- Known exposure to hepatitis B virus within 6 months.
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 |
|---|---|---|
| Henogen HBV vaccine20µg, Month 0, 2 and 6 | Biological | 1 |
| FENDRIX20 µg,Months 0, 1, 2 and 6 | Biological | 2 |
Primary outcome
Anti-HBs seroprotection rate at Month 2.
Time frame: Month 0 and 2
10 secondary outcomes
Anti-HBs antibody concentrations
Time frame: Months 0, 1, 2, 3, 6 and 7
Anti-HBs seroprotection rates for all subjects.
Time frame: Months 0, 1, 2, 3, 6 and 7
Anti-HBs seropositivity rates for all subjects
Time frame: Months 0, 1, 2, 3, 6 and 7
Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects.
Time frame: Months 0, 1, 2, 3, 6 and 7
Anti-HBs geometric mean concentrations calculated for all subjects.
Time frame: Months 0, 1, 2, 3, 6 and 7
Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group.
Time frame: Months 0 and 7
Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group.
Time frame: Month 0 and 7
Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall.
Time frame: Month 0, 1, 2, 3, 6 and 7
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall.
Time frame: Month 0, 1, 2, 3, 6 and 7
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7.
Time frame: Month 0 to 7
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
24 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 Henogen HBV vaccine and FENDRIX in people with Hepatitis B, run by Henogen at 24 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 5 inclusion and 13 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 24 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 at Month 2. (time frame: Month 0 and 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.