Hepatitis BPhase 3NCT00445185
Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™
A Phase 3 study testing Henogen HB vaccine and Fendrix vaccine in people with Hepatitis B, run by Henogen at 23 sites in 3 countries.
Trial summary
The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives \& outcome measures of the extension phase at Months 12, 24 and 36. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Henogen HB vaccine and Fendrix vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 23 sitesin 3 countries
- Study dates
- Mar 2007to Nov 2009
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
- Subjects who completed the full course of primary vaccination.
Who cannot join
- Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
- Any confirmed or suspected human immunodeficiency virus (HIV) infection.
Trial locations and contacts
23 sites in 3 countries.
23 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
CHU Brugmann (site V Horta) Service de néphrologie
Brussels, 1020
ULB Hôpital Erasme Département de Néphrologie
Brussels, 1070
AZ -VUB Dienst Nefrologie
Brussels, 1090
Cliniques universitaires Saint Luc
Brussels, 1200
CHU Hôpital civil de
Charleroi, 6000
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
Hospital JihlavaVrchlického
Jihlava, 59586 33
Regional Hospital Liberec
Liberec, 46063
University Hospital with Outpatient Clinic Ostrava
Ostrava, 708 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
Győr, 9023
Pest County Flór Ferenc Hospital
Kistarcsa, 2143
Vas and Szombathely County Markusovszky Hospital
Szombathely, 9700
About this study
Official title: A Study to Evaluate the Persistence of Anti-HBs Antibodies at Months 12, 24 and 36 in Pre-dialysis or Dialysis Patients Who Have Received a Primary Vaccination Course of Either Henogen's HBV Vaccine, HB-AS02V or GSK Biological's Fendrix™
The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives \& outcome measures of the extension phase at Months 12, 24 and 36. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).
Read the detailed description
Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.
- Conditions
- Hepatitis B
- Being tested
- Henogen HB vaccine, Fendrix vaccine
- Keywords
- Dialysis, Pre-dialysis, Hepatitis B vaccine, vaccine
- 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 HB vaccineBiological
Month 12, 24 and 36
Fendrix vaccineBiological
Month 12, 24 and 36
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Henogen Hepatitis B vaccine for uremic patients Receives: Biological: Henogen HB vaccine |
| 2 | Active comparator | Fendrix hepatitis B vaccine for uremic patients Receives: Biological: Fendrix vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs antibody concentrations
Measured: Months 12, 24 and 36.
Secondary outcomes (3)
Quality of immune response
Measured: Month 12, 24 and 36
SAEs retrospective reporting
Measured: Month 12, 24 and 36
RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001).
Measured: Month 12, 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joëlle Nortier, MD, PhD, Principal investigator, ULB Hôpital Erasme Département de Néphrologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445185
- Sponsor's protocol ID
- HN015/HBV-EXT001
- Status last verified
- Nov 2009
- First submitted
- 7 Mar 2007
- Last updated
- 19 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Surquin M, Tielemans C, Nortier J, Jadoul M, Peeters P, Ryba M, Roznovsky L, Doman J, Barthelemy X, Crasta PD, Messier M, Houard S. Anti-HBs antibody persistence following primary vaccination with an investigational AS02(v)-adjuvanted hepatitis B vaccine in patients with renal insufficiency. Hum Vaccin. 2011 Sep;7(9):913-8. doi: 10.4161/hv.7.9.16225. Epub 2011 Sep 1.
PubMed 21892006
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Persistence of Anti-HBs Antibodies at Months 12, 24 and 36 in Pre-dialysis or Dialysis Patients Who Have Received a Primary Vaccination Course of Either Henogen's HBV Vaccine, HB-AS02V or GSK Biological's Fendrix™
- ClinicalTrials.gov ID
- NCT00445185
- Acronym / sponsor ID
- HN015/HBV-EXT001
- Conditions
- Hepatitis B
- Keywords
- Dialysis, Pre-dialysis, Hepatitis B vaccine, vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- HenogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 Mar 2007 (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 current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives \& outcome measures of the extension phase at Months 12, 24 and 36. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).
Detailed description
Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.
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 HB vaccineHenogen Hepatitis B vaccine for uremic patients |
| 2 | Active comparator | Biological: Fendrix vaccineFendrix hepatitis B vaccine for uremic patients |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
- Subjects who completed the full course of primary vaccination.
Key exclusion criteria (2 listed)
- Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
- Any confirmed or suspected human immunodeficiency virus (HIV) infection.
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 HB vaccineMonth 12, 24 and 36 | Biological | 1 |
| Fendrix vaccineMonth 12, 24 and 36 | Biological | 2 |
Primary outcome
Anti-HBs antibody concentrations
Time frame: Months 12, 24 and 36.
3 secondary outcomes
Quality of immune response
Time frame: Month 12, 24 and 36
SAEs retrospective reporting
Time frame: Month 12, 24 and 36
RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001).
Time frame: Month 12, 24 and 36
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 19 Nov 2009.
- Derived from this study: PubMed 21892006Surquin M, Tielemans C, Nortier J, Jadoul M, Peeters P, Ryba M, Roznovsky L, Doman J, Barthelemy X, Crasta PD, Messier M, Houard S. Anti-HBs antibody persistence following primary vaccination with an investigational AS02(v)-adjuvanted hepatitis B vaccine in patients with renal insufficiency. Hum Vaccin. 2011 Sep;7(9):913-8. doi: 10.4161/hv.7.9.16225. Epub 2011 Sep 1.
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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.
Joëlle Nortier, MD, PhD principal investigator
ULB Hôpital Erasme Département de Néphrologie
23 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 HB vaccine and Fendrix vaccine in people with Hepatitis B, run by Henogen at 23 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 2 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 19 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 antibody concentrations (time frame: Months 12, 24 and 36.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00445185, which also lists 1 linked publication.
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 19 Nov 2009.