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Lead
Dynavax Technologies Corporation
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
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 be if
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
Clareo Health | Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease