Status:
COMPLETED
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
Lead Sponsor:
Dynavax Technologies Corporation
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT01195246
Start Date
December 1 2010
End Date
August 1 2012
Last Update
March 20 2019
Active Locations (19)
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1
Aschaffenburg, Germany
2
Bamberg, Germany
3
Berlin, Germany
4
Cologne, Germany