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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT01195246
First received: September 2, 2010
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
End Stage Renal Disease
Biological: HEPLISAV
Biological: Engerix-B
Biological: Fendrix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall incidence of post-injection reactions and adverse events in each treatment group [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Enrollment: 155
Study Start Date: December 2010
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HEPLISAV
0.5 mL 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)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195246

Locations
Germany
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT01195246     History of Changes
Other Study ID Numbers: DV2-HBV-18, 2010-019633-10
Study First Received: September 2, 2010
Last Updated: July 16, 2014
Health Authority: Germany: Paul Ehrlich Institut (PEI)

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
hepatitis
HBV
prevention and control
dialysis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Kidney Diseases
Kidney Failure, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
Renal Insufficiency
Renal Insufficiency, Chronic
RNA Virus Infections
Urologic Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014