An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV-B® to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)

Dynavax Technologies Corporation1 site in 1 country521 target enrollmentSeptember 2009

ConditionsChronic Kidney Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Kidney Disease
Sponsor: Dynavax Technologies Corporation
Enrollment: 521
Locations: 1
Primary Endpoint: Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

January 2012

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dynavax Technologies Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•be 18 to 75 years of age;
•progressive loss of renal function as defined by glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m²;
•be clinically stable in the opinion of the investigator;
•be serum negative for HBsAg, anti-HBsAg, antibody to hepatitis B core antigen (HBcAg), Hepatitis C virus (HCV), and human immunodeficiency virus (HIV);
•if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection;
•is not scheduled to undergo a kidney transplant in the next 12 months;
•be able and willing to provide informed consent.

Exclusion Criteria

•if female, is pregnant, breastfeeding, or planning a pregnancy;
•has a history of or is considered by the investigator to be at high risk for recent exposure to HBV, HCV, or HIV; for example, current intravenous drug use, has unprotected sex with known HBV/HIV positive partner;
•has known history of autoimmune disease;
•has previously received any HBV vaccine;
•has a history of sensitivity to any component of study vaccines;
•has current illness other than renal disease or has substance or alcohol abuse that in the opinion of the investigator 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 or hypertension;
•is unwilling or unable to comply with all the requirements of the protocol;
•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;

Outcomes

Primary Outcomes

Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response

Time Frame: Week 28

SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B.

Secondary Outcomes

Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52(Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52)
SPR of Participants With Type 2 Diabetes Mellitus at Week 28(Week 28)
Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit(7 days after each injection visit (Weeks 0, 4, 8, and 24))
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52(Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52)
Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52(Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52)