Clinical trial NCT01282762: Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Prevention of Hepatitis B infection.
End Stage Renal Disease
Hepatitis B vaccination
Hepatitis B virus (HBV)
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2011-01-25
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Chronic Kidney Disease previously enrolled in the Dynavax clinical studies DV2-HBV-17 and DV2-HBV-18

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by seroprotection rate (SPR) (anti-HBsAg> 10 milli-international unit (mIU)/mL
timeFrame: Baseline
measure: To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
timeFrame: 6 months
measure: To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
timeFrame: 12 months
measure: To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
timeFrame: 24 months
measure: To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
timeFrame: 36 months
measure: To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
timeFrame: 48 months
Secondary outcomes:
measure: To evaluate the safety of HEPLISAV and Engerix-B in CKD subjects who previously received at least one hepatitis B vaccine series.
timeFrame: Baseline and 6,12, 24, 36 and 48 months
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
Study officials:
References: