Hepatitis BPhase 2NCT00498212
A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease
A Phase 2 study testing 1018 ISS-HBsAg-Single and 1018 ISS-HBsAg-Double in people with Hepatitis B, run by Dynavax Technologies Corporation at 3 sites in Canada.
Trial summary
The purpose of this study is to find out if a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients. Two dose levels will be studied: a single dose and a double dose. We expect both dose levels to safely immunize patients against HBV. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- 1018 ISS-HBsAg-Single and 1018 ISS-HBsAg-Double
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2007to Oct 2008
- Phase
- Phase 2
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent
- Have a glomerular filtration rate (GFR) ≤ 45 mL/min
- Have an expectation of going on hemodialysis or are already on hemodialysis
- Is serum negative for hepatitis B virus (HBV) antibodies, hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
- Have repeated resting blood pressure measurements ≤ 165/105 mmHg
- Women of childbearing potential must be consistently using a highly effective method of birth control
Who cannot join
- Women who are pregnant, breastfeeding or planning a pregnancy
- Any previous HBV infection
- Previous vaccination (1 or more doses) with any HBV vaccine
- Any previous autoimmune diseases
- Have a diagnosis of chronic renal failure due to autoimmune disease
- Are at high risk for recent exposure to HBV, HCV or HIV
Show all 10Show fewer
- Received any 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
3 sites in 1 country.
Canada3 sites
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1E7
SMBD - Jewish General Hospital
Montreal, Quebec, H3T 1E2
White Hills Medical Clinic
St. John's, Newfoundland and Labrador, A1A 3R5
About this study
Official title: A Phase 2, Single-Blind, Randomized Study of Safety and Immunogenicity Following Vaccination With Single or Double Doses of HEPLISAV™ in Adults With End-Stage Renal Disease
The purpose of this study is to find out if a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients. Two dose levels will be studied: a single dose and a double dose. We expect both dose levels to safely immunize patients against HBV. The study will determine which dose does this best.
Read the detailed description
Infection with hepatitis B virus (HBV) is a major global health problem. Worldwide, it is estimated that 2 billion people have been infected previously and 350 million are chronically infected. While acute HBV infection is associated with significant illness, the risk of chronic infection is of great importance since 5-10% of infected adults will not clear the infection after the initial phase of the illness. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis.
This study will evaluate the safety and immunogenicity of HEPLISAV™ when administered to adults who have end-stage renal disease (glomerular filtration rate [GFR] ≤ 45 mL/min). Once subjects have been consented, screened, and randomized to treatment, subjects will receive a total of three injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Subjects will receive 1 of the following 2 regimens:
- HEPLISAV™ single dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months)
- HEPLISAV™ double dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months)
Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local and systemic reactogenicity.
Immunogenicity will be evaluated by the proportion of subjects exhibiting a seroprotective immune response (anti-hepatitis B surface antigen antibodies [anti-HBsAg] ≥ 10 milli-international unit (mIU)/mL) at Weeks 4, 12, 24, 28 and 50.
- Conditions
- Hepatitis B
- Being tested
- 1018 ISS-HBsAg-Single, 1018 ISS-HBsAg-Double
- Keywords
- Heplisav, Hepatitis B, Hepatitis, HBV, Hepatitis B vaccine, kidney disease, renal disease, kidney failure, renal failure
- Medical subject headings
- Hepatitis B, Hepatitis, Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1018 ISS-HBsAg-SingleBiological
Also called HEPLISAV™
Intramuscular (IM) injection at Day 0, Week 4 and Week 24
1018 ISS-HBsAg-DoubleBiological
Also called HEPLISAV™
Intramuscular (IM) injection at Day 0, Week 4 and Week 24
| Study group | Role | What they receive |
|---|---|---|
| 1018 ISS-HBsAg-Single | Experimental | Single dose (3000 µg 1018 ISS + 20 µg rHBsAg) Receives: Biological: 1018 ISS-HBsAg-Single |
| 1018 ISS-HBsAg-Double | Experimental | Double dose (6000 µg 1018 ISS + 40 µg rHBsAg) Receives: Biological: 1018 ISS-HBsAg-Double |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events and local and systemic reaction rates
Measured: 28 weeks
Secondary outcomes (1)
Portion of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 mIU/ml)
Measured: 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionOct 2008
Why it stopped: Voluntary halt due to an FDA Clinical Hold issued in relation to DV2-HBV-10.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduardo Martins, MD, D Phil, Study director, Dynavax Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498212
- Sponsor's protocol ID
- DV2-HBV-11
- Status last verified
- Mar 2019
- First submitted
- 5 Jul 2007
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Blind, Randomized Study of Safety and Immunogenicity Following Vaccination With Single or Double Doses of HEPLISAV™ in Adults With End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00498212
- Acronym / sponsor ID
- DV2-HBV-11
- Conditions
- Hepatitis B
- Keywords
- Heplisav, Hepatitis B, Hepatitis, HBV, Hepatitis B vaccine, kidney disease, renal disease, kidney failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Voluntary halt due to an FDA Clinical Hold issued in relation to DV2-HBV-10.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Jul 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 purpose of this study is to find out if a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients. Two dose levels will be studied: a single dose and a double dose. We expect both dose levels to safely immunize patients against HBV. The study will determine which dose does this best.
Detailed description
Infection with hepatitis B virus (HBV) is a major global health problem. Worldwide, it is estimated that 2 billion people have been infected previously and 350 million are chronically infected. While acute HBV infection is associated with significant illness, the risk of chronic infection is of great importance since 5-10% of infected adults will not clear the infection after the initial phase of the illness. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis.
This study will evaluate the safety and immunogenicity of HEPLISAV™ when administered to adults who have end-stage renal disease (glomerular filtration rate [GFR] ≤ 45 mL/min). Once subjects have been consented, screened, and randomized to treatment, subjects will receive a total of three injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Subjects will receive 1 of the following 2 regimens:
- HEPLISAV™ single dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months)
- HEPLISAV™ double dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months)
Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local and systemic reactogenicity.
Immunogenicity will be evaluated by the proportion of subjects exhibiting a seroprotective immune response (anti-hepatitis B surface antigen antibodies [anti-HBsAg] ≥ 10 milli-international unit (mIU)/mL) at Weeks 4, 12, 24, 28 and 50.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1018 ISS-HBsAg-Single | Experimental | Biological: 1018 ISS-HBsAg-SingleSingle dose (3000 µg 1018 ISS + 20 µg rHBsAg) |
| 1018 ISS-HBsAg-Double | Experimental | Biological: 1018 ISS-HBsAg-DoubleDouble dose (6000 µg 1018 ISS + 40 µg rHBsAg) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to give written informed consent
- Have a glomerular filtration rate (GFR) ≤ 45 mL/min
- Have an expectation of going on hemodialysis or are already on hemodialysis
- Is serum negative for hepatitis B virus (HBV) antibodies, hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
- Have repeated resting blood pressure measurements ≤ 165/105 mmHg
Key exclusion criteria (10 listed)
- Women who are pregnant, breastfeeding or planning a pregnancy
- Any previous HBV infection
- Previous vaccination (1 or more doses) with any HBV vaccine
- Any previous autoimmune diseases
- Have a diagnosis of chronic renal failure due to autoimmune disease
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 |
|---|---|---|
| 1018 ISS-HBsAg-SingleAlso: HEPLISAV™Intramuscular (IM) injection at Day 0, Week 4 and Week 24 | Biological | 1018 ISS-HBsAg-Single |
| 1018 ISS-HBsAg-DoubleAlso: HEPLISAV™Intramuscular (IM) injection at Day 0, Week 4 and Week 24 | Biological | 1018 ISS-HBsAg-Double |
Primary outcome
Occurrence of adverse events and local and systemic reaction rates
Time frame: 28 weeks
1 secondary outcome
Portion of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 mIU/ml)
Time frame: 50 weeks
Results and safety
The study was stopped early (reason given: Voluntary halt due to an FDA Clinical Hold issued in relation to DV2-HBV-10.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Dynavax WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, D Phil study director
Dynavax Technologies Corporation
3 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 1018 ISS-HBsAg-Single and 1018 ISS-HBsAg-Double in people with Hepatitis B, run by Dynavax Technologies Corporation at 3 sites in Canada.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 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 3 sites in Canada. 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?
The study was stopped early (reason given: Voluntary halt due to an FDA Clinical Hold issued in relation to DV2-HBV-10.). Results are not available in the source record.
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?
Occurrence of adverse events and local and systemic reaction rates (time frame: 28 weeks). 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 26 Mar 2019.