End Stage Renal DiseasePhase 3NCT01195246
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
A Phase 3 study testing HEPLISAV, Engerix-B and Fendrix in people with End Stage Renal Disease, run by Dynavax Technologies Corporation at 19 sites in Germany.
Trial summary
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- HEPLISAV, Engerix-B and Fendrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 19 sitesGermany
- Study dates
- Dec 2010to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Has loss of renal function and is receiving hemodialysis treatments
- Is not seroprotected against hepatitis B (has anti-HBs < 10 mIU/mL)
- In the opinion of the investigator, is clinically stable
- Be serum negative for HBsAg, anti-hepatitis B core antigen (HBc), hepatitis C virus (HCV), and HIV
- Is not scheduled to undergo a kidney transplant during the study period
- If female, and of childbearing potential, subject must be: surgically sterile or neither pregnant nor breast-feeding, consistently using a highly effective method of birth control for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study.
Who cannot join
- If female, is pregnant, breastfeeding, or planning a pregnancy;
- Has a history of or is at high risk for recent exposure to HBV, HCV, or HIV;
- Has known history of autoimmune disease;
- Has history of sensitivity to any component of study vaccines;
- Has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results;
- Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin;
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- Has uncontrolled diabetes;
- Has received a kidney transplant previously that is still functioning and requires anti-rejection medication;
- Has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;
- Has received the following prior to the study injection: 3 days: intravenous iron; 21 days: any inactivated virus or bacterial vaccine; 28 days: any live virus or bacterial vaccine; systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids; granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF); any other investigational medicinal agent;
- At any time: an injection of deoxyribonucleic acid (DNA) plasmids or oligonucleotides; investigational or intradermal hepatitis B vaccine.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Germany19 sites
Study site
Aschaffenburg
Study site
Bamberg
Study site
Berlin
Study site
Cologne
Study site
Dresden
Study site
Düsseldorf
Study site
Essen
Study site
Halle
Study site
Hamburg
Study site
Hanover
Study site
Leipzig
Study site
Madgeburg
Study site
Mainz
Study site
Mannheim-Kafertal
Study site
München
Study site
Oberschleißheim
Study site
Rostock
Study site
Trier
Study site
Velbert
About this study
Official title: An Open-Label, Randomized, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Engerix-B® and Fendrix® in Adults on Hemodialysis Who Have Previously Received Hepatitis B Vaccination and Are Not Seroprotected
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis.
Read the detailed description
The immune response of HEPLISAV compared with Engerix-B and Fendrix and measured by seroprotection rate (SPR) at 4 weeks after the booster injection
- Conditions
- End Stage Renal Disease
- Being tested
- HEPLISAV, Engerix-B, Fendrix
- Keywords
- end stage renal failure, renal failure, kidney failure, kidney failure, chronic, chronic kidney failure, hepatitis B virus (HBV) vaccine, hepatitis B vaccine, hepatitis B, hepatitis, HBV, prevention and control, dialysis
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Renal Insufficiency, Hepatitis B, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPLISAVBiological
Also called Hepatitis B Vaccine (Recombinant), Adjuvanted
Intramuscular (IM) injection on Day1
Engerix-BBiological
Also called Hepatitis B Vaccine (Recombinant)
Intramuscular (IM) injection on Day 1
FendrixBiological
Also called Hepatitis B Vaccine (Recombinant)
Intramuscular (IM) injection on Day 1
| Study group | Role | What they receive |
|---|---|---|
| HEPLISAV | Experimental | 0.5 mL HEPLISAV Receives: Biological: HEPLISAV |
| Engerix-B | Active comparator | 2.0 mL Engerix-B Receives: Biological: Engerix-B |
| Fendrix | Active comparator | 0.5 mL Fendrix Receives: Biological: Fendrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with seroprotection rate (SPR), defined as the percentage of subjects with anti-HBsAg serum concentration of 10 milli-international unit (mIU)/mL or higher, measured at Week 4
Measured: week 4
Secondary outcomes (1)
Overall incidence of post-injection reactions and adverse events in each treatment group
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195246
- Sponsor's protocol ID
- DV2-HBV-18
- Other IDs
- 2010-019633-10
- Status last verified
- Mar 2019
- First submitted
- 2 Sep 2010
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: a/o August 2016, decision is still pending.
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
- An Open-Label, Randomized, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Engerix-B® and Fendrix® in Adults on Hemodialysis Who Have Previously Received Hepatitis B Vaccination and Are Not Seroprotected
- ClinicalTrials.gov ID
- NCT01195246
- Acronym / sponsor ID
- DV2-HBV-18
- Conditions
- End Stage Renal Disease
- Keywords
- end stage renal failure, renal failure, kidney failure, kidney failure, chronic, chronic kidney failure, hepatitis B virus (HBV) vaccine, hepatitis B vaccine, hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Sep 2010 (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 compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis.
Detailed description
The immune response of HEPLISAV compared with Engerix-B and Fendrix and measured by seroprotection rate (SPR) at 4 weeks after the booster injection
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HEPLISAV | Experimental | Biological: HEPLISAV0.5 mL HEPLISAV |
| Engerix-B | Active comparator | Biological: Engerix-B2.0 mL Engerix-B |
| Fendrix | Active comparator | Biological: Fendrix0.5 mL Fendrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- Has loss of renal function and is receiving hemodialysis treatments
- Is not seroprotected against hepatitis B (has anti-HBs < 10 mIU/mL)
- In the opinion of the investigator, is clinically stable
- Be serum negative for HBsAg, anti-hepatitis B core antigen (HBc), hepatitis C virus (HCV), and HIV
Key exclusion criteria (11 listed)
- If female, is pregnant, breastfeeding, or planning a pregnancy;
- Has a history of or is at high risk for recent exposure to HBV, HCV, or HIV;
- Has known history of autoimmune disease;
- Has history of sensitivity to any component of study vaccines;
- Has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results;
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 |
|---|---|---|
| HEPLISAVAlso: Hepatitis B Vaccine (Recombinant), AdjuvantedIntramuscular (IM) injection on Day1 | Biological | HEPLISAV |
| Engerix-BAlso: Hepatitis B Vaccine (Recombinant)Intramuscular (IM) injection on Day 1 | Biological | Engerix-B |
| FendrixAlso: Hepatitis B Vaccine (Recombinant)Intramuscular (IM) injection on Day 1 | Biological | Fendrix |
Primary outcome
Proportion of subjects with seroprotection rate (SPR), defined as the percentage of subjects with anti-HBsAg serum concentration of 10 milli-international unit (mIU)/mL or higher, measured at Week 4
Time frame: week 4
1 secondary outcome
Overall incidence of post-injection reactions and adverse events in each treatment group
Time frame: week 12
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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. a/o August 2016, decision is still pending.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HEPLISAV, Engerix-B and Fendrix in people with End Stage Renal Disease, run by Dynavax Technologies Corporation at 19 sites in Germany.
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 7 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 19 sites in 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?
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?
Proportion of subjects with seroprotection rate (SPR), defined as the percentage of subjects with anti-HBsAg serum concentration of 10 milli-international unit (mIU)/mL or higher, measured at Week 4 (time frame: 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 20 Mar 2019.