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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195246
• Other study ID #: DV2-HBV-18
• Secondary ID: 2010-019633-10
• Status: Completed
• Phase: Phase 3
• Start date: December 2010
• Est. completion date: August 2012

Study information

• Verified date: March 2019
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hepatitis
• Hepatitis B
• Kidney Failure, Chronic

Intervention

Biological:
• HEPLISAV
Intramuscular (IM) injection on Day1
• Engerix-B
Intramuscular (IM) injection on Day 1
• Fendrix
Intramuscular (IM) injection on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall incidence of post-injection reactions and adverse events in each treatment group		week 12

External Links

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