Clinical trial NCT01195246: Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease
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
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: week 4
Secondary outcomes:
measure: Overall incidence of post-injection reactions and adverse events in each treatment group
timeFrame: week 12
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
city: Bamberg
country: Germany
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Dusseldorf
country: Germany
city: Essen
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Koln
country: Germany
city: Leipzig
country: Germany
city: Madgeburg
country: Germany
city: Mainz
country: Germany
city: Mannheim-Kafertal
country: Germany
city: Munchen
country: Germany
city: Oberschleißheim
country: Germany
city: Rostock
country: Germany
city: Trier
country: Germany
city: Velbert
country: Germany
Study officials:
References: