Hepatitis BPhase 1NCT00426712
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
A Phase 1 study testing 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen and Hepatitis B Vaccine (Recombinant) in people with Hepatitis B, run by Dynavax Technologies Corporation at 4 sites in United States.
Trial summary
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and are expected to eventually go on… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen and Hepatitis B Vaccine (Recombinant)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2006to Mar 2008
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent
- Progressive loss of kidney function with more advanced stage 3 (GFR at least 45 mL/min) or stage 4 chronic kidney disease by National Kidney Foundation classification, and are expected to eventually go on hemodialysis
- Body mass index of 31 or less
Who cannot join
- Received previous vaccination with any HBV vaccine (1 or more doses)
- Any history of HBV infection
- Pregnant or breast-feeding, or planning a pregnancy during the study
- Has autoimmune disease
- Diagnosis of chronic kidney failure due to autoimmune disease
- Receiving hemodialysis treatment at the time of enrollment
Show all 11Show fewer
- Received any blood products or antibodies within 3 months prior to study entry, or is likely to require blood products during the study
- Ever received an injection with DNA plasmids or oligonucleotides
- Received erythropoietin within 7 days prior to the first study injection
- Received vaccination with any vaccines during the 4 weeks prior to study entry
- Received any other investigational medicinal agent during the 4 weeks prior to study entry
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Covance
Austin, Texas, 78727
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430
University of Virginia Health System, Nephrology Clinical Research Center
Charlottesville, Virginia, 22908
West Coast Clinical Trials
Costa Mesa, California, 92626
About this study
Official title: A Phase 1, Randomized, Observer-blind, Dose-escalating Study in Adult End-stage Renal Failure Patients to Explore the Safety, Tolerability, Pharmacokinetics and Immune Response to Recombinant Hepatitis B Virus Surface Antigen (rHBsAg) Co-administered With Dynavax Immunostimulatory Phosphorothioate Oligodeoxyribonucleotide (1018 ISS)
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and are expected to eventually go on hemodialysis.
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. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis. Hemodialysis and pre-dialysis patients with kidney failure have multiple immune defects that make them more likely to develop a chronic infection. In addition, hemodialysis increases the risk of exposure to HBV. Existing HBV vaccines are effective in preventing infection in healthy adults. However, poor responses occur in people who are over 40 years of age and have end-stage kidney failure.
This study will evaluate the safety, tolerability and immune response of three escalating dose levels of HEPLISAV™, compared with a commercially available HBV vaccine, Engerix-B®, in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease and are expected to eventually go on hemodialysis. About 72 patients will be included in the study. Once patients have been consented, screened, and randomized to treatment, they will receive four injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Patients will receive treatment with one of three escalating dose levels of HEPLISAV™ or the comparator vaccine, Engerix-B®.
- Conditions
- Hepatitis B
- Being tested
- 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen, Hepatitis B Vaccine (Recombinant)
- Keywords
- Chronic kidney failure, Chronic kidney disease, Hemodialysis, HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Prevention & Control
- Medical subject headings
- Hepatitis B, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1018 ISS immunostimulatory oligonucleotide with HBV surface antigenBiological
Also called HEPLISAV™
Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
Hepatitis B Vaccine (Recombinant)Biological
Also called ENGERIX-B®
IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low dose Receives: Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen |
| 2 | Experimental | Middle dose Receives: Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen |
| 3 | Experimental | High dose Receives: Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen |
| 4 | Active comparator | Not described Receives: Biological: Hepatitis B Vaccine (Recombinant) |
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 antibody ≥ 10 mIU/mL)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionMar 2008
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 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
- NCT00426712
- Sponsor's protocol ID
- DV2-HBV-09
- Status last verified
- Mar 2019
- First submitted
- 23 Jan 2007
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: 3/2017 No change to status of this study
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 1, Randomized, Observer-blind, Dose-escalating Study in Adult End-stage Renal Failure Patients to Explore the Safety, Tolerability, Pharmacokinetics and Immune Response to Recombinant Hepatitis B Virus Surface Antigen (rHBsAg) Co-administered With Dynavax Immunostimulatory Phosphorothioate Oligodeoxyribonucleotide (1018 ISS)
- ClinicalTrials.gov ID
- NCT00426712
- Acronym / sponsor ID
- DV2-HBV-09
- Conditions
- Hepatitis B
- Keywords
- Chronic kidney failure, Chronic kidney disease, Hemodialysis, HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 25 Jan 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 vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and are expected to eventually go on hemodialysis.
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. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis. Hemodialysis and pre-dialysis patients with kidney failure have multiple immune defects that make them more likely to develop a chronic infection. In addition, hemodialysis increases the risk of exposure to HBV. Existing HBV vaccines are effective in preventing infection in healthy adults. However, poor responses occur in people who are over 40 years of age and have end-stage kidney failure.
This study will evaluate the safety, tolerability and immune response of three escalating dose levels of HEPLISAV™, compared with a commercially available HBV vaccine, Engerix-B®, in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease and are expected to eventually go on hemodialysis. About 72 patients will be included in the study. Once patients have been consented, screened, and randomized to treatment, they will receive four injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Patients will receive treatment with one of three escalating dose levels of HEPLISAV™ or the comparator vaccine, Engerix-B®.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigenLow dose |
| 2 | Experimental | Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigenMiddle dose |
| 3 | Experimental | Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigenHigh dose |
| 4 | Active comparator | Biological: Hepatitis B Vaccine (Recombinant) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to give written informed consent
- Progressive loss of kidney function with more advanced stage 3 (GFR at least 45 mL/min) or stage 4 chronic kidney disease by National Kidney Foundation classification, and are expected to eventually go on hemodialysis
- Body mass index of 31 or less
Key exclusion criteria (11 listed)
- Received previous vaccination with any HBV vaccine (1 or more doses)
- Any history of HBV infection
- Pregnant or breast-feeding, or planning a pregnancy during the study
- Has autoimmune disease
- Diagnosis of chronic kidney 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 immunostimulatory oligonucleotide with HBV surface antigenAlso: HEPLISAV™Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8 | Biological | 1, 2, 3 |
| Hepatitis B Vaccine (Recombinant)Also: ENGERIX-B®IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24 | Biological | 4 |
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 antibody ≥ 10 mIU/mL)
Time frame: 28 days
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 20 Mar 2019.
- Dynavax WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 3/2017 No change to status of this study
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen and Hepatitis B Vaccine (Recombinant) in people with Hepatitis B, run by Dynavax Technologies Corporation at 4 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 3 inclusion and 11 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 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 20 Mar 2019.