Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis

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: NCT01195246
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Biological: HEPLISAV Biological: Engerix-B Biological: Fendrix Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : December 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: HEPLISAV
Biological: HEPLISAV
Intramuscular (IM) injection on Day1
Other Name: Hepatitis B Vaccine (Recombinant), Adjuvanted
Active Comparator: Engerix-B
2.0 mL Engerix-B
Biological: Engerix-B
Intramuscular (IM) injection on Day 1
Other Name: Hepatitis B Vaccine (Recombinant)
Active Comparator: Fendrix
0.5 mL Fendrix
Biological: Fendrix
Intramuscular (IM) injection on Day 1
Other Name: Hepatitis B Vaccine (Recombinant)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall incidence of post-injection reactions and adverse events in each treatment group [ Time Frame: week 12 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  • 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;
  • 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.

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): NCT01195246

Aschaffenburg, Germany
Bamberg, Germany
Berlin, Germany
Dresden, Germany
Dusseldorf, Germany
Essen, Germany
Halle, Germany
Hamburg, Germany
Hannover, Germany
Koln, Germany
Leipzig, Germany
Madgeburg, Germany
Mainz, Germany
Mannheim-Kafertal, Germany
Munchen, Germany
Oberschleißheim, Germany
Rostock, Germany
Trier, Germany
Velbert, Germany
Sponsors and Collaborators
Dynavax Technologies Corporation

Additional Information:
Responsible Party: Dynavax Technologies Corporation Identifier: NCT01195246     History of Changes
Other Study ID Numbers: DV2-HBV-18
2010-019633-10 ( EudraCT Number )
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: a/o August 2016, decision is still pending.

Keywords provided by Dynavax Technologies Corporation:
end stage renal failure
renal failure
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:
Hepatitis B
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs