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

April 28, 2021 updated by: Dynavax Technologies Corporation

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

521

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HEPLISAV-B
0.5 mL HEPLISAV-B and 0.5 mL Placebo
Biological: HEPLISAV-B
Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24
Other Names:
  • Hepatitis B vaccine (recombinant), adjuvanted
Other: Placebo
Placebo(saline) intramuscular (IM) injection at Week 8
Other Names:
  • Saline
Active Comparator: Engerix-B
2.0 mL Engerix-B
Biological: Engerix-B
Intramuscular (IM) injections at Weeks 0, 4, 8, and 24
Other Names:
  • Hepatitis B vaccine (recombinant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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.
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
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.
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
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
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
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.
Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynavax Technologies Corporation

Investigators

  • Study Director: Robert Janssen, MD, Dynavax Technologies Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV2-HBV-17
  • 2009-015877-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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