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

Completed

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT01282762

Run by

Dynavax Technologies Corporation

People needed

147

Starts

2010-12-01

Expected to finish

2013-08-01

Last updated by the study team

2019-03-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Associates of Tidewater — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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