Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
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
2 other identifiers
interventional
155
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2010
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2010
CompletedFirst Posted
Study publicly available on registry
September 6, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedMarch 20, 2019
March 1, 2019
1.2 years
September 2, 2010
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
week 4
Secondary Outcomes (1)
Overall incidence of post-injection reactions and adverse events in each treatment group
week 12
Study Arms (3)
HEPLISAV
EXPERIMENTAL0.5 mL HEPLISAV
Engerix-B
ACTIVE COMPARATOR2.0 mL Engerix-B
Fendrix
ACTIVE COMPARATOR0.5 mL Fendrix
Interventions
Intramuscular (IM) injection on Day1
Intramuscular (IM) injection on Day 1
Intramuscular (IM) injection on Day 1
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Aschaffenburg, Germany
Unknown Facility
Bamberg, Germany
Unknown Facility
Berlin, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Dresden, Germany
Unknown Facility
Düsseldorf, Germany
Unknown Facility
Essen, Germany
Unknown Facility
Halle, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Leipzig, Germany
Unknown Facility
Madgeburg, Germany
Unknown Facility
Mainz, Germany
Unknown Facility
Mannheim-Kafertal, Germany
Unknown Facility
München, Germany
Unknown Facility
Oberschleißheim, Germany
Unknown Facility
Rostock, Germany
Unknown Facility
Trier, Germany
Unknown Facility
Velbert, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2010
First Posted
September 6, 2010
Study Start
December 1, 2010
Primary Completion
February 1, 2012
Study Completion
August 1, 2012
Last Updated
March 20, 2019
Record last verified: 2019-03