Hepatitis BPhase 3NCT00435812
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
A Phase 3 study testing Engerix-B in people with Hepatitis B, run by Dynavax Technologies Corporation at 18 sites in 2 countries.
Trial summary
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®. Read more about this study
- Who is it for?
- Ages 11 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Engerix-B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,428 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Dec 2006to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Willing and able to give written informed consent
- Is serum negative for HBV antibodies
Who cannot join
- Women who are pregnant or breastfeeding
- Any previous HBV infection
- Previous vaccination with any HBV vaccine (1 or more doses)
- Any autoimmune disease
- Received any blood products or antibodies within 3 months prior to study entry
- Ever received an injection with DNA plasmids or oligonucleotides
- Received any vaccines within 4 weeks prior to study entry
- Received any other investigational medicinal agent within 4 weeks prior to study entry
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Canada12 sites
Study site
Charlottetown, Prince Edward Island
Study site
Edmonton, Alberta
Study site
Halifax, Nova Scotia
Study site
Montreal, Quebec
Study site
Mount Pearl, Newfoundland and Labrador
Study site
Ottawa, Ontario
Study site
Québec, Quebec
Study site
Sarnia, Ontario
Study site
St. John's, Newfoundland and Labrador
Study site
Surrey, British Columbia
Study site
Toronto, Ontario
Study site
Winnipeg, Manitoba
Germany6 sites
Study site
Berlin
Study site
Hamburg
Study site
Leipzig
Study site
Magdeburg
Study site
Munich
Study site
Ulm
About this study
Official title: A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.
Read the detailed description
This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available hepatitis B virus (HBV) vaccine, Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the study. Once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection of placebo. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine, Engerix-B®.
- Conditions
- Hepatitis B
- Being tested
- HEPLISAV and/or Placebo, Engerix-B
- Keywords
- HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Immunostimulatory sequence (ISS)
- Medical subject headings
- Hepatitis B, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPLISAV and/or PlaceboBiological
Also called HEPLISAV, Hepatitis B vaccine (recombinant), adjuvanted
Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24
Engerix-BBiological
Also called Hepatitis B vaccine (recombinant)
Intramuscular (IM) injections on Week 0, Week 4, and Week 24
| Study group | Role | What they receive |
|---|---|---|
| HEPLISAV and/or Placebo | Experimental | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Receives: Biological: HEPLISAV and/or Placebo |
| Engerix-B | Active comparator | 1.0 mL Engerix-B Receives: Biological: Engerix-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Seroprotective Immune Response
Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)
Measured: Week 12 for HEPLISAV and Week 28 for Engerix-B
Secondary outcomes (1)
Percentage of Participants With Local and Systemic Reactions to Injections
Measured: Within 7 days post-injection for Post Injection Reactions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Tyler Martin, Sr, MD, Study director, Dynavax Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435812
- Sponsor's protocol ID
- DV2-HBV-10
- Other IDs
- 2006-006743-31
- Status last verified
- Mar 2019
- First submitted
- 13 Feb 2007
- Last updated
- 20 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®
- ClinicalTrials.gov ID
- NCT00435812
- Acronym / sponsor ID
- DV2-HBV-10
- Conditions
- Hepatitis B
- Keywords
- HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Immunostimulatory sequence (ISS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,428 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Feb 2007 (estimated)
- Results
- Posted 13 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.
Detailed description
This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available hepatitis B virus (HBV) vaccine, Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the study. Once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection of placebo. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine, Engerix-B®.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEPLISAV and/or Placebo | Experimental | Biological: HEPLISAV and/or Placebo0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) |
| Engerix-B | Active comparator | Biological: Engerix-B1.0 mL Engerix-B |
Who may qualify
- Ages
- 11 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Willing and able to give written informed consent
- Is serum negative for HBV antibodies
Key exclusion criteria (8 listed)
- Women who are pregnant or breastfeeding
- Any previous HBV infection
- Previous vaccination with any HBV vaccine (1 or more doses)
- Any autoimmune disease
- Received any blood products or antibodies within 3 months prior to study entry
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 |
|---|---|---|
| HEPLISAV and/or PlaceboAlso: HEPLISAV, Hepatitis B vaccine (recombinant), adjuvantedIntramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24 | Biological | HEPLISAV and/or Placebo |
| Engerix-BAlso: Hepatitis B vaccine (recombinant)Intramuscular (IM) injections on Week 0, Week 4, and Week 24 | Biological | Engerix-B |
Primary outcome
Percentage of Subjects With Seroprotective Immune Response
Time frame: Week 12 for HEPLISAV and Week 28 for Engerix-B
Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)
1 secondary outcome
Percentage of Participants With Local and Systemic Reactions to Injections
Time frame: Within 7 days post-injection for Post Injection Reactions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Dynavax WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
J. Tyler Martin, Sr, MD study director
Dynavax Technologies Corporation
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Engerix-B in people with Hepatitis B, run by Dynavax Technologies Corporation at 18 sites in 2 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 8 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada, Germany. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With Seroprotective Immune Response (time frame: Week 12 for HEPLISAV and Week 28 for Engerix-B). 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 20 Mar 2019.