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

March 18, 2019 updated by: Dynavax Technologies Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

155

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

  • 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

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HEPLISAV
0.5 mL HEPLISAV
Biological: HEPLISAV
Intramuscular (IM) injection on Day1
Other Names:
  • Hepatitis B Vaccine (Recombinant), Adjuvanted
ACTIVE_COMPARATOR: Engerix-B
2.0 mL Engerix-B
Biological: Engerix-B
Intramuscular (IM) injection on Day 1
Other Names:
  • Hepatitis B Vaccine (Recombinant)
ACTIVE_COMPARATOR: Fendrix
0.5 mL Fendrix
Biological: Fendrix
Intramuscular (IM) injection on Day 1
Other Names:
  • Hepatitis B Vaccine (Recombinant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall incidence of post-injection reactions and adverse events in each treatment group
Time Frame: week 12
week 12

Collaborators and Investigators

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

Sponsor

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.

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

December 1, 2010

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 2, 2010

First Posted (ESTIMATE)

September 6, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV2-HBV-18
  • 2010-019633-10 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

a/o August 2016, decision is still pending.

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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