End Stage Renal Disease on Hemodialysis (Diagnosis)Phase 1NCT03934736
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
A Phase 1 study testing HEPLISAV-B® in people with End Stage Renal Disease on Hemodialysis (Diagnosis), run by Dynavax Technologies Corporation at 20 sites in United States.
Trial summary
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Hemodialysis (Diagnosis)
- What is being tested?
- HEPLISAV-B®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 20 sitesUnited States
- Study dates
- 22 Apr 2019to 15 Sep 2021
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects at least 18 years of age
- Laboratory confirmed negative serology result to hepatitis B virus (HBV) surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc) prior to first study injection
- Must be clinically stable and in the opinion of the investigator able to comply with all study procedures
- Must be able and willing to provide informed consent
- Receiving hemodialysis or will initiate hemodialysis within 4 weeks of first study injection
- Women of childbearing potential (WOCBP) must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening visit through 4 weeks after the last dose of study injection. Acceptable birth control methods include but are not limited to oral contraceptive medication, an intrauterine device (IUD), an injectable contraceptive (such as medroxyprogesterone acetate or Depo-Provera®), a birth control patch, or a barrier method (such as condom or diaphragm with spermicide).
Who cannot join
- Previous receipt of any hepatitis B vaccine
- History of human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection or antibody to HIV or HCV
- History of sensitivity to any component of study vaccine
- Substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results
- Recent or ongoing history of febrile illness (within 7 days of the first study injection)
- Has received any of the following prior to the first study injection:
Show all 27Show fewer
- Within 14 days:
- Any inactivated vaccine
- Within 28 days:
- Systemic corticosteroids (more than 3 consecutive days) or other immunomodulatory or immune suppressive medication with the exception of inhaled steroids
- Any live virus vaccine
- Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Any other investigational medicinal agent
- Within 90 days:
- Blood products or immunoglobulin
- If female and pregnant, nursing, or planning to become pregnant during the study
- Undergoing chemotherapy or expected to receive chemotherapy during the study period
- Has a medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments, including the following laboratory abnormalities which the investigator may consider if severe:
- Anemia
- Thrombocytopenia
- Leukocytosis
- Neutropenia
- Metabolic acidosis
- Increased alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- Hyperkalemia
- Hypokalemia
- Is scheduled to undergo a kidney transplant within 6 months of the first study injection
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
DaVita Clinical Research or Affiliate
Asheville, North Carolina, 28801
DaVita Clinical Research or Affiliate
Bloomfield, Connecticut, 06002
DaVita Clinical Research or Affiliate
Canton, Ohio, 44718
DaVita Clinical Research or Affiliate
Edina, Minnesota, 55435
DaVita Clinical Research or Affiliate
El Paso, Texas, 79902
DaVita Clinical Research or Affiliate
Hollywood, Florida, 33021
DaVita Clinical Research or Affiliate
Jeffersonville, Indiana, 47130
DaVita Clinical Research or Affiliate
Kansas City, Missouri, 64111
DaVita Clinical Research or Affiliate
Las Vegas, Nevada, 89106
DaVita Clinical Research or Affiliate
Middlebury, Connecticut, 06762
DaVita Clinical Research or Affiliate
Milwaukee, Wisconsin, 53227
DaVita Clinical Research or Affiliate
Minneapolis, Minnesota, 55404
DaVita Clinical Research or Affiliate
Norfolk, Virginia, 23510
DaVita Clinical Research or Affiliate
Ocala, Florida, 34471
DaVita Clinical Research or Affiliate
Philadelphia, Pennsylvania, 19106
DaVita Clinical Research or Affiliate
Roseville, Michigan, 48066
DaVita Clinical Research or Affiliate
San Antonio, Texas, 78229
DaVita Clinical Research or Affiliate
Tampa, Florida, 33614
DaVita Clinical Research or Affiliate
The Bronx, New York, 10461
DaVita Clinical Research or Affiliate
Winter Park, Florida, 32789
About this study
Official title: An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
Read the detailed description
Eligible participants will receive single doses of HEPLISAV-B® at Weeks 0, 4, 8, and 16 and will be followed through Week 68 or end of study (EOS). The study is designed to evaluate the immunogenicity over a 20-week period and safety over a 68-week period.
- Being tested
- HEPLISAV-B®
- Keywords
- ESRD, Hemodialysis, End Stage Renal Disease, Hepatitis B, HEPLISAV-B, Prevention and Control, HBV Vaccine, Hepatitis B Vaccine, HEPLISAV
- Medical subject headings
- Disease, Kidney Failure, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPLISAV-B®Drug
HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine for adults 18 years of age and older, consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
| Study group | Role | What they receive |
|---|---|---|
| HEPLISAV-B® | Experimental | A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). Receives: Drug: HEPLISAV-B® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
Proportion of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations.
Measured: Week 0 (Visit 1) until Week 68 or early termination
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B
Measured: Week 20
Secondary outcomes (3)
Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL
Percentage of subjects with anti-HBs concentration ≥100 mIU/mL.
Measured: Weeks 4, 8, 16, 20
Serum Anti-HBsAg Geometric Mean Concentration (GMC)
Serum Anti-HBsAg Geometric Mean Concentration (GMC).
Measured: Weeks 4, 8, 16, 20
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B
Measured: Weeks 4, 8, 16, 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start22 Apr 2019
- Primary completion23 Oct 2020
- Study completion15 Sep 2021
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 End Stage Renal Disease on Hemodialysis (Diagnosis)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Janssen, MD, Study chair, Dynavax Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934736
- Sponsor's protocol ID
- DV2-HBV-24
- Status last verified
- Aug 2024
- First submitted
- 11 Feb 2019
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT03934736
- Acronym / sponsor ID
- DV2-HBV-24
- Keywords
- ESRD, Hemodialysis, End Stage Renal Disease, Hepatitis B, HEPLISAV-B, Prevention and Control, HBV Vaccine, Hepatitis B Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
Detailed description
Eligible participants will receive single doses of HEPLISAV-B® at Weeks 0, 4, 8, and 16 and will be followed through Week 68 or end of study (EOS). The study is designed to evaluate the immunogenicity over a 20-week period and safety over a 68-week period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEPLISAV-B® | Experimental | Drug: HEPLISAV-B®A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects at least 18 years of age
- Laboratory confirmed negative serology result to hepatitis B virus (HBV) surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc) prior to first study injection
- Must be clinically stable and in the opinion of the investigator able to comply with all study procedures
- Must be able and willing to provide informed consent
- Receiving hemodialysis or will initiate hemodialysis within 4 weeks of first study injection
Key exclusion criteria (27 listed)
- Previous receipt of any hepatitis B vaccine
- History of human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection or antibody to HIV or HCV
- History of sensitivity to any component of study vaccine
- Substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results
- Recent or ongoing history of febrile illness (within 7 days of the first study injection)
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-B®HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine for adults 18 years of age and older, consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg). | Drug | HEPLISAV-B® |
Primary outcome
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
Time frame: Week 0 (Visit 1) until Week 68 or early termination
Proportion of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations.
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
Time frame: Week 20
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B
3 secondary outcomes
Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL
Time frame: Weeks 4, 8, 16, 20
Serum Anti-HBsAg Geometric Mean Concentration (GMC)
Time frame: Weeks 4, 8, 16, 20
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
Time frame: Weeks 4, 8, 16, 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Robert Janssen, MD study chair
Dynavax Technologies Corporation
20 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 HEPLISAV-B® in people with End Stage Renal Disease on Hemodialysis (Diagnosis), run by Dynavax Technologies Corporation at 20 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 6 inclusion and 27 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Yes. Results are posted in the registry (first posted 9 Aug 2024). 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 Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest (time frame: Week 0 (Visit 1) until Week 68 or early termination). The study lists 2 primary outcomes in all. 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 9 Aug 2024.