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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
First received
Last updated
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
Health authority
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.

Study Design


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
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