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

Phase 3

Completed

• Conditions: End Stage Renal Disease
• Interventions: Biological: HEPLISAV; Biological: Engerix-B; Biological: Fendrix

• Registration Number: NCT01195246
• Lead Sponsor: Dynavax Technologies Corporation

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

Study Timeline

• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-06
• Study Start: 2010-12
• Primary Completion: 2012-02
• Study Completion: 2012-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEPLISAV	HEPLISAV	0.5 mL HEPLISAV
Engerix-B	Engerix-B	2.0 mL Engerix-B
Fendrix	Fendrix	0.5 mL Fendrix

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall incidence of post-injection reactions and adverse events in each treatment group	week 12