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

Dynavax Technologies Corporation

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Biological: Engerix-B; Biological: HEPLISAV

Study type: Observational

Funder types: Industry

Identifiers

NCT01282762

DV2-HBV-19

Details and patient eligibility

About

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.

Full 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

Enrollment: 147 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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