Chronic Kidney DiseasePhase 3NCT00985426

Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients

A Phase 3 study testing HEPLISAV-B and Engerix-B in people with Chronic Kidney Disease, run by Dynavax Technologies Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Kidney Disease
What is being tested?: HEPLISAV-B and Engerix-B
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 521 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Jan 2012
Phase: Phase 3
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

be 18 to 75 years of age;
progressive loss of renal function as defined by glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m²;
be clinically stable in the opinion of the investigator;
be serum negative for HBsAg, anti-HBsAg, antibody to hepatitis B core antigen (HBcAg), Hepatitis C virus (HCV), and human immunodeficiency virus (HIV);
if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection;
is not scheduled to undergo a kidney transplant in the next 12 months;
be able and willing to provide informed consent.

Who cannot join

if female, is pregnant, breastfeeding, or planning a pregnancy;
has a history of or is considered by the investigator to be at high risk for recent exposure to HBV, HCV, or HIV; for example, current intravenous drug use, has unprotected sex with known HBV/HIV positive partner;
has known history of autoimmune disease;
has previously received any HBV vaccine;
has a history of sensitivity to any component of study vaccines;
has current illness other than renal disease or has substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results;

Show all 19Show fewer

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;
has uncontrolled diabetes or hypertension;
is unwilling or unable to comply with all the requirements of the protocol;
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 first injection:
3 days: erythropoietin (exclusionary window does not apply for subjects on dialysis)
7 days: intravenous iron
21 days: any inactivated virus vaccine
28 days:
any live virus vaccine
systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
granulocyte or granulocyte-macrophage colony-simulating factor (G/GM-CSF), any other investigational medicinal agent
At any time: an injection of deoxyribonucleic acid plasmids or oligonucleotide

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507

Other trials in United States

About this study

Official title: An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV-B® to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)

Conditions: Chronic Kidney Disease
Being tested: HEPLISAV-B, Engerix-B, Placebo
Keywords: chronic kidney disease, 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: Renal Insufficiency, Chronic, Renal Insufficiency, Kidney Failure, Chronic, Hepatitis B, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HEPLISAV-BBiological
Also called Hepatitis B vaccine (recombinant), adjuvanted
Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24
Engerix-BBiological
Also called Hepatitis B vaccine (recombinant)
Intramuscular (IM) injections at Weeks 0, 4, 8, and 24
PlaceboOther
Also called Saline
Placebo(saline) intramuscular (IM) injection at Week 8

Study groups in NCT00985426
Study group	Role	What they receive
HEPLISAV-B	Experimental	0.5 mL HEPLISAV-B and 0.5 mL Placebo Receives: Biological: HEPLISAV-B; Other: Placebo
Engerix-B	Active comparator	2.0 mL Engerix-B Receives: Biological: Engerix-B

What is being measured

The primary outcome is the main question the study is designed to answer.

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 compared to that after Engerix-B.
Measured: Week 28

Secondary outcomes (5)

Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit
Local reactions include redness greater than or equal to 25 mm, swelling greater than or equal to 25 mm, and pain.
Systemic reactions include malaise, headache, myalgia, fatigue, and fever (temperature greater than or equal to 38ºC).
This table presents post-injection reactions at active injection visits only. Post-injection reactions after the third (placebo) injection visit in the HEPLISAV-B group are not included.
Measured: 7 days after each injection visit (Weeks 0, 4, 8, and 24)
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
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 compared to that after Engerix-B.
Measured: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Measured: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Measured: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
SPR of Participants With Type 2 Diabetes Mellitus at Week 28
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 compared to that after Engerix-B.
Measured: Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Jan 2012

First posted28 Sep 2009 (estimated)
Study startSep 2009
Primary completionJan 2012
Study completionJan 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 521 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00985426
Sponsor's protocol ID: DV2-HBV-17
Other IDs: 2009-015877-11, 2009
Status last verified: Apr 2021
First submitted: 24 Sep 2009
Last updated: 19 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Janssen RS, Mangoo-Karim R, Pergola PE, Girndt M, Namini H, Rahman S, Bennett SR, Heyward WL, Martin JT. Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease. Vaccine. 2013 Nov 4;31(46):5306-13. doi: 10.1016/j.vaccine.2013.05.067. Epub 2013 May 30.
PubMed 23727422

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV-B® to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)
ClinicalTrials.gov ID: NCT00985426
Acronym / sponsor ID: DV2-HBV-17
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease, kidney failure, kidney failure,chronic, chronic kidney failure, hepatitis B virus (HBV) vaccine, hepatitis B vaccine, hepatitis B, hepatitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 521 participants (actual)
Lead sponsor: Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 28 Sep 2009 (estimated)
Results: Posted 16 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
HEPLISAV-B	Experimental	Biological: HEPLISAV-B, Other: Placebo0.5 mL HEPLISAV-B and 0.5 mL Placebo
Engerix-B	Active comparator	Biological: Engerix-B2.0 mL Engerix-B

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

be 18 to 75 years of age;
progressive loss of renal function as defined by glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m²;
be clinically stable in the opinion of the investigator;
be serum negative for HBsAg, anti-HBsAg, antibody to hepatitis B core antigen (HBcAg), Hepatitis C virus (HCV), and human immunodeficiency virus (HIV);
if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection;

Key exclusion criteria (19 listed)

if female, is pregnant, breastfeeding, or planning a pregnancy;
has a history of or is considered by the investigator to be at high risk for recent exposure to HBV, HCV, or HIV; for example, current intravenous drug use, has unprotected sex with known HBV/HIV positive partner;
has known history of autoimmune disease;
has previously received any HBV vaccine;
has a history of sensitivity to any component of study vaccines;

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-BAlso: Hepatitis B vaccine (recombinant), adjuvantedIntramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24	Biological	HEPLISAV-B
Engerix-BAlso: Hepatitis B vaccine (recombinant)Intramuscular (IM) injections at Weeks 0, 4, 8, and 24	Biological	Engerix-B
PlaceboAlso: SalinePlacebo(saline) intramuscular (IM) injection at Week 8	Other	HEPLISAV-B

Primary outcome

Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
Time frame: Week 28
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 compared to that after Engerix-B.

5 secondary outcomes

Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit
Time frame: 7 days after each injection visit (Weeks 0, 4, 8, and 24)
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Time frame: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Time frame: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Time frame: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
SPR of Participants With Type 2 Diabetes Mellitus at Week 28
Time frame: Week 28

Results and safety

Results posted to the registry on 16 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HEPLISAV-B	258	215
Engerix-B	263	219

Primary outcome: Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response

Time frame: Week 28. Count of participants. Unit: Participants

Measure	HEPLISAV-B n = 227	Engerix-B n = 242
Value	204	198

HEPLISAV-B vs Engerix-B: SPR Difference (%): 8 (95% CI 1.7 to 14.3)
HEPLISAV-B vs Engerix-B: SPR Difference (%): 8 (95% CI 1.7 to 14.3)

Population analysed: Modified Intent-to-Treat (mITT) population comprises all randomized participants who received at least 1 study injection and had at least 1 post-injection immunogenicity evaluation.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reporting period for adverse events (AEs) that were not serious adverse events (SAEs) was the time from the first study injection until Week 28. Reporting period for SAEs was the time from the signing of the informed consent form until Week 52 (or completion of the participant's participation in the study).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HEPLISAV-B	68 of 254 (26.8%)	140 of 254 (55.1%)	7 of 254
Engerix-B	76 of 262 (29%)	146 of 262 (55.7%)	3 of 262

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23727422Janssen RS, Mangoo-Karim R, Pergola PE, Girndt M, Namini H, Rahman S, Bennett SR, Heyward WL, Martin JT. Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease. Vaccine. 2013 Nov 4;31(46):5306-13. doi: 10.1016/j.vaccine.2013.05.067. Epub 2013 May 30.
Related InfoLink 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.

Robert Janssen, MD study director

Dynavax Technologies Corporation

1 site 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-B and Engerix-B in people with Chronic Kidney Disease, run by Dynavax Technologies Corporation at 1 site 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 7 inclusion and 19 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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

Yes. Results are posted in the registry (first posted 16 Dec 2020). 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?

Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response (time frame: Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00985426, which also lists 1 linked publication.

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 19 May 2021.