End Stage Renal Disease
Conditions
Keywords
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
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.
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
Interventions
Sponsors
Dynavax Technologies Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| 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 | week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Overall incidence of post-injection reactions and adverse events in each treatment group | week 12 |
Countries
Germany
Outcome results
None listed