Hepatitis BPhase 3NCT00480116
Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule
A Phase 3 study testing Adjuvanted Hepatitis B vaccine Lot 1, Adjuvanted Hepatitis B vaccine Lot 2 and Adjuvanted Hep B vaccine Lot 3 in people with Hepatitis B, run by Henogen at 1 site in Czechia.
Trial summary
The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Adjuvanted Hepatitis B vaccine Lot 1, Adjuvanted Hepatitis B vaccine Lot 2 and Adjuvanted Hep B vaccine Lot 3
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2008to Apr 2008
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy male or female adult aged between 18 and 40 years.
- Written informed consent obtained from the subject
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose.
- Concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hepatitis B infection.
- Known exposure to hepatitis B virus within 6 months.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Vaccination and Travel Medicine Centre Poliklinika II
Hradec Králové, 500 03
About this study
Official title: Phase III, Single Centre, Double Blind, Randomised Study Evaluating the Consistency of Three Lots of Henogen's New Adjuvanted Hepatitis B Vaccine, When Given at 0, 1 Month Schedule in Healthy Volunteers Aged 18 Years to 40 Years.
The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.
Read the detailed description
Double-blind, randomised, single centre study with three groups receiving three different lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood samples will be taken at Month 0, Months 1 and 2.
- Conditions
- Hepatitis B
- Being tested
- Adjuvanted Hepatitis B vaccine Lot 1, Adjuvanted Hepatitis B vaccine Lot 2, Adjuvanted Hep B vaccine Lot 3
- Keywords
- Consistency, Immunogenicity
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvanted Hepatitis B vaccine Lot 1Biological
20 µg, IM, month 0 and 1
Adjuvanted Hepatitis B vaccine Lot 2Biological
20µg, IM, month 0 and 1
Adjuvanted Hep B vaccine Lot 3Biological
20µg, IM, month 0 and 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Biological: Adjuvanted Hepatitis B vaccine Lot 1 |
| 2 | Active comparator | Not described Receives: Biological: Adjuvanted Hepatitis B vaccine Lot 2 |
| 3 | Active comparator | Not described Receives: Biological: Adjuvanted Hep B vaccine Lot 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs seroprotection rates at Month 2.
Measured: Month 2
Secondary outcomes (4)
Anti-HBs geometric mean concentration, seropositivity rates, seroprotection rates and the percentage of subjects with antibody concentrations superior or equal to 100 mIU/ml after HB-AS02V vaccination, at all time points.
Measured: Month 0, 1 and 2
Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms, within 4 days after administration of study vaccine (Day 0 to 3).
Measured: Month 0 and 1
Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)
Measured: Month 0 and 1
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 posted30 May 2007 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jiri Beran, MD, Principal investigator, Vaccination and Travel Medicine Centre Poliklinika II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480116
- Sponsor's protocol ID
- HN016/HBV-002
- Status last verified
- Aug 2008
- First submitted
- 29 May 2007
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Beran J, Hobzova L, Wertzova V, Kuriyakose S, Leyssen M, Surquin M, Houard S. Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults. Hum Vaccin. 2010 Jul;6(7):578-84. doi: 10.4161/hv.6.7.11883. Epub 2010 Jul 1.
PubMed 20523113
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Single Centre, Double Blind, Randomised Study Evaluating the Consistency of Three Lots of Henogen's New Adjuvanted Hepatitis B Vaccine, When Given at 0, 1 Month Schedule in Healthy Volunteers Aged 18 Years to 40 Years.
- ClinicalTrials.gov ID
- NCT00480116
- Acronym / sponsor ID
- HN016/HBV-002
- Conditions
- Hepatitis B
- Keywords
- Consistency, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- HenogenIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 30 May 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 study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.
Detailed description
Double-blind, randomised, single centre study with three groups receiving three different lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood samples will be taken at Month 0, Months 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Adjuvanted Hepatitis B vaccine Lot 1 |
| 2 | Active comparator | Biological: Adjuvanted Hepatitis B vaccine Lot 2 |
| 3 | Active comparator | Biological: Adjuvanted Hep B vaccine Lot 3 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- A healthy male or female adult aged between 18 and 40 years.
- Written informed consent obtained from the subject
Key exclusion criteria (9 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose.
- Concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hepatitis B 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 |
|---|---|---|
| Adjuvanted Hepatitis B vaccine Lot 120 µg, IM, month 0 and 1 | Biological | 1 |
| Adjuvanted Hepatitis B vaccine Lot 220µg, IM, month 0 and 1 | Biological | 2 |
| Adjuvanted Hep B vaccine Lot 320µg, IM, month 0 and 1 | Biological | 3 |
Primary outcome
Anti-HBs seroprotection rates at Month 2.
Time frame: Month 2
4 secondary outcomes
Anti-HBs geometric mean concentration, seropositivity rates, seroprotection rates and the percentage of subjects with antibody concentrations superior or equal to 100 mIU/ml after HB-AS02V vaccination, at all time points.
Time frame: Month 0, 1 and 2
Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms, within 4 days after administration of study vaccine (Day 0 to 3).
Time frame: Month 0 and 1
Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)
Time frame: Month 0 and 1
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 25 Aug 2008.
- Derived from this study: PubMed 20523113Beran J, Hobzova L, Wertzova V, Kuriyakose S, Leyssen M, Surquin M, Houard S. Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults. Hum Vaccin. 2010 Jul;6(7):578-84. doi: 10.4161/hv.6.7.11883. Epub 2010 Jul 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.
Jiri Beran, MD principal investigator
Vaccination and Travel Medicine Centre Poliklinika II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvanted Hepatitis B vaccine Lot 1, Adjuvanted Hepatitis B vaccine Lot 2 and Adjuvanted Hep B vaccine Lot 3 in people with Hepatitis B, run by Henogen at 1 site in Czechia.
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 9 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 25 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 1 site in Czechia. 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 rates at Month 2. (time frame: Month 2). 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 NCT00480116, 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 25 Aug 2008.