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

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

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