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Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in Chronic Kidney Disease (CKD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00985426
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : February 22, 2018
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Brief Summary:
The purpose of the study is to explore the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive loss of kidney function.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Biological: HEPLISAV and Placebo Biological: Engerix-B Phase 3

Detailed Description:
The purpose of the study is to explore the safety and Immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive loss of kidney function.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)
Study Start Date : September 2009
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: HEPLISAV and Placebo
0.5 mL HEPLISAV and Placebo
Biological: HEPLISAV and Placebo
Intramuscular (IM) injections of HEPLISAV at Weeks 0, 4, and 24; placebo(saline) injection at Week 8
Other Name: Hepatitis B vaccine (recombinant), adjuvanted
Active Comparator: Engerix-B
2.0 mL Engerix-B
Biological: Engerix-B
Intramuscular (IM) injections at Weeks 0, 4, 8, and 24
Other Name: Hepatitis B vaccine (recombinant)

Primary Outcome Measures :
  1. Proportion of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mlU)/mL) at week 28. [ Time Frame: week 28 ]

Secondary Outcome Measures :
  1. Overall incident of post-injection reactions and adverse events in each treatment group [ Time Frame: week 52 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00985426

United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Dynavax Technologies Corporation
Study Director: Robert Janssen, MD Dynavax Technologies Corporation

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dynavax Technologies Corporation Identifier: NCT00985426     History of Changes
Other Study ID Numbers: DV2-HBV-17
2009-015877-11 ( EudraCT Number )
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dynavax Technologies Corporation:
chronic kidney disease
kidney failure
kidney failure,chronic
chronic kidney failure
hepatitis B virus (HBV) vaccine
hepatitis B vaccine
hepatitis B
prevention and control

Additional relevant MeSH terms:
Kidney Diseases
Hepatitis B
Renal Insufficiency, Chronic
Urologic Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Renal Insufficiency
Immunologic Factors
Physiological Effects of Drugs