Hepatitis BPhase 2NCT00511095
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
A Phase 2 study testing HEPLISAV in people with Hepatitis B, run by Dynavax Technologies Corporation at 7 sites in United States.
Trial summary
The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated. 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?
- HEPLISAV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2007to Mar 2008
- Phase
- Phase 2
- 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
- Women of childbearing potential must be willing to consistently use a highly effective method of birth control
Who cannot join
- Women who are pregnant or breastfeeding
- Any previous HBV infection
- Previous vaccination (1 or more doses) with any HBV vaccine
- Any previous autoimmune diseases
- Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
- Received any blood products or antibodies within 3 months prior to study entry
Show all 9Show fewer
- 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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Beeghley Medical Park
Boardman, Ohio, 44512
Metropolitan Research
Fairfax, Virginia, 22031
Family Healthcare Partners
Grove City, Pennsylvania, 16127
Pediatric Alliance Southwestern
Pittsburgh, Pennsylvania, 15217
Primary Physicians Research
Pittsburgh, Pennsylvania, 15241
Family Practice Medical Associates South
Upper Saint Clair, Pennsylvania, 15241
The Washington Hospital Family Medicine
Washington, Pennsylvania, 15301
About this study
Official title: An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™
The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.
Read the detailed description
This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.
- Conditions
- Hepatitis B
- Being tested
- HEPLISAV
- Keywords
- Hepatitis B vaccine, HBV vaccine, Hepatitis B, Hepatitis, HBV, Vaccine, 1018, HBsAg
- 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.
HEPLISAVBiological
Intramuscular (IM) injections 0.5mL on Day 0 and Week 4
| Study group | Role | What they receive |
|---|---|---|
| HEPLISAV | Experimental | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL Receives: Biological: HEPLISAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Local and Systemic Post-injection Reaction Rates
Local and Systemic post-injection reactions.
Measured: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4
Secondary outcomes (2)
Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.
Seroprotective Immune Response
Measured: Weeks 4, 8, 12 and 28
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28
Measurement of Serum GMC
Measured: Weeks 4, 8, 12, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2007
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduardo Martins, MD, DPhil, Study director, Dynavax Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511095
- Sponsor's protocol ID
- DV2-HBV-14
- Status last verified
- Apr 2019
- First submitted
- 25 Jul 2007
- Last updated
- 30 Apr 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 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™
- ClinicalTrials.gov ID
- NCT00511095
- Acronym / sponsor ID
- DV2-HBV-14
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B vaccine, HBV vaccine, Hepatitis B, Hepatitis, HBV, Vaccine, 1018, HBsAg
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Posted 12 Apr 2017
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 further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.
Detailed description
This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEPLISAV | Experimental | Biological: HEPLISAV0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL |
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
- Women of childbearing potential must be willing to consistently use a highly effective method of birth control
Key exclusion criteria (9 listed)
- Women who are pregnant or breastfeeding
- Any previous HBV infection
- Previous vaccination (1 or more doses) with any HBV vaccine
- Any previous autoimmune diseases
- Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
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 |
|---|---|---|
| HEPLISAVIntramuscular (IM) injections 0.5mL on Day 0 and Week 4 | Biological | HEPLISAV |
Primary outcome
Percentage of Participants With Local and Systemic Post-injection Reaction Rates
Time frame: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4
Local and Systemic post-injection reactions.
2 secondary outcomes
Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.
Time frame: Weeks 4, 8, 12 and 28
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28
Time frame: Weeks 4, 8, 12, and 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 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
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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.
Eduardo Martins, MD, DPhil study director
Dynavax Technologies Corporation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HEPLISAV in people with Hepatitis B, run by Dynavax Technologies Corporation at 7 sites in United States.
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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Apr 2017). 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 Participants With Local and Systemic Post-injection Reaction Rates (time frame: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4). 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 30 Apr 2019.