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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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HEPLISAV

0.5 mL administered intramuscularly (IM) at Week 0, Week 4 and Week 24.

HEPLISAV booster injection = one dose of 0.5 mL volume when needed.

Intervention Type BIOLOGICAL

Engerix-B

2.0 mL administered intramuscularly (IM) at Week 0, Week 4, Week 8 and Week 24.

Engerix-B booster injection = one dose of 2.0 mL volume when needed

Intervention Type BIOLOGICAL

Other Intervention Names

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Hepatitis B vaccine (recombinant), adjuvanted Hepatitis B vaccine (recombinant)

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No