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Hepatitis BPhase 3NCT00291980

A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.

A Phase 3 study testing HB-AS02V vaccine and HBVAXPRO vaccine in people with Hepatitis B, run by Henogen at 28 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. 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 vaccine and HBVAXPRO vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
28 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

  • Subjects whom the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
  • 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/ subject's parents or guardians.
  • Pre-dialysis patients, peritoneal dialysis patients and patients on haemodialysis. Pre-dialysis patients is defined as a subject with a documented creatinine clearance of les or equal to 30 ml/min.
  • Seronegative for anti-HBc antibodies and for HBsAg at screening.
  • Documented previous hepatitis B vaccination with one full primary course of licensed vaccine (the cumulative dose for primary vaccination is at least 160 mg of hepatitis B vaccine) with or without subsequent boosters. The last dose should have been administered at least three months before the planned dose of study vaccine in this study.
  • Documented response to previous hepatitis B vaccination (i.e. anti-HBs antibody concentrations ³ 10 mIU/ml after primary vaccination or after booster/s with licensed vaccine), but for whom there is a loss of anti-HBs antibody concentrations below 10 mIU/ml at the time of inclusion into the study. Patients who have antibody concentrations below 50 mIU/ml at the time of inclusion will also be recruited provided that this antibody concentration is less than half of the highest documented antibody response achieved after primary vaccination or booster/s. The interval between the blood sample corresponding to the documented response and the hepatitis B vaccine dose received prior to this blood sample should be at least 25 days
  • If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used medically-approved contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Who cannot join

  • Subjects who have participated in the HN014/HBV-001 or HN017/HBV-003 study
  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the study vaccine administration, or planned use during the study period.
  • Use of any registered vaccine within 7 days preceding the study vaccine administration.
  • History of hepatitis B infection.
  • Known exposure to hepatitis B virus within six months.
  • Use of immunoglobulins within six months preceding the first study vaccination.
Show all 13Show fewer
  • 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 equal or superior to 37.5 °C (or 37 °C in Czech Republic).
  • Pregnant or lactating female

Trial locations and contacts

28 sites in 3 countries.

28 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

Other trials in Belgium

Czechia9 sites

  • Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska

    Hradec Králové, 581500 05

  • Hospital JihlavaVrchlického

    Jihlava, 59586 33

  • Regional Hospital Liberec

    Liberec, 46063

  • 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 Prague 4

    Prague, 142 00

  • Dept. of Internal Medicine StrahovSermirska 5

    Prague, 169 00

  • Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska

    Sokolov, 1863356 01

Other trials in Czechia

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

  • Vas and Szombathely County Markusovszky Hospital

    Szombathely, 9700

Other trials in Hungary

About this study

Official title: A Phase III, Multicentric, Multinational, Controlled, Randomised, Open Study Comparing the Immunogenicity, Reactogenicity and Safety of Henogen's New Adjuvanted Hepatitis B Vaccine, HB-AS02V, to That of Aventis Pasteur MSD's Hepatitis B Vaccine, HBVAXPRO® , Administered as a Booster Dose in Pre-Dialysis, Peritoneal Dialysis and Haemodialysis Subjects (³ 15 Years of Age) Who Previously Responded to Hepatitis B Primary Vaccination But Have Lost Antibody.

The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more immunogenic vaccine, allowing higher antibody concentrations, 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 3 visits and blood samples will taken at each of these visits.

Conditions
Hepatitis B
Being tested
HB-AS02V vaccine, 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-AS02V vaccineBiological

    HB-AS02V (20µg HBsAg) will be administered at Month 0

  • HBVAXPRO vaccineBiological

    HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0

Study groups in NCT00291980
Study groupRoleWhat they receive
1ExperimentalHB-AS02V vaccine
Receives: Biological: HB-AS02V vaccine
2Active comparatorHBVAXPRO vaccine
Receives: Biological: HBVAXPRO vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-HBs antibody geometric mean concentrations.

    Measured: Month 0 and Month 1

Secondary outcomes (7)

  1. Seroprotection rates for all subjects

    Measured: Months 0, 1

  2. Seropositivity rates for all subjects

    Measured: Month 0 and at Month 1

  3. Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects

    Measured: Month 0 and at Month 1

  4. Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects

    Measured: Month 0 and Month 1

  5. Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms during the 4-day follow-up after vaccination

    Measured: Month 0

  6. Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after vaccination

    Measured: Month 0

  7. Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1

    Measured: Month 0 to 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

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
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291980
Sponsor's protocol ID
HN018/HBV-004 (105754)
Status last verified
Aug 2008
First submitted
14 Feb 2006
Last updated
28 Aug 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HB-AS02V vaccine and HBVAXPRO vaccine in people with Hepatitis B, run by Henogen at 28 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 8 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 28 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 geometric mean concentrations. (time frame: Month 0 and Month 1). 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 NCT00291980.

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.

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