Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT01282762
• Lead Sponsor: Dynavax Technologies Corporation

Brief Summary

The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in a cohort of chronic kidney disease (CKD) patients over time.

Detailed Description

An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™ compared with Engerix-B® in Adults with Chronic Kidney Disease who Have Previously Received At Least One Hepatitis B Vaccine Series

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-21
• Study First Posted: 2011-01-25
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

A subject must meet all of the following inclusion criteria to participate in the study:

• enrolled and completed HEPLISAV or Engerix-B treatment in: DV2-HBV-17 or DV2-HBV-18 and had anti-HBsAg ≥ 10 mIU/mL prior to or during DV2-HBV-18
• previously received a complete primary hepatitis B vaccine series in DV2-HBV-17 or prior to enrollment in DV2-HBV-18
• be otherwise clinically stable in the opinion of the investigator
• be able and willing to provide informed consent

Exclusion Criteria

A subject who meets any ONE of the following exclusion criteria is not permitted to participate in the study:

• previously enrolled in DV2-HBV-18 and never obtained anti-HBsAg ≥ 10 mIU/mL
• received hepatitis B vaccine off-study after enrolling in DV2-HBV-17 or DV2-HBV-18
• has known history of autoimmune disease
• is unwilling or unable to comply with all the requirements of the protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL	48 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by seroprotection rate (SPR) (anti-HBsAg> 10 milli-international unit (mIU)/mL	Baseline

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of HEPLISAV and Engerix-B in CKD subjects who previously received at least one hepatitis B vaccine series.	Baseline and 6,12, 24, 36 and 48 months

Trial Locations

Locations (1)

Clinical Research Associates of Tidewater; 🇺🇸 Norfolk, Virginia, United States