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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01282762

Enrollment

147

Registered

2011-01-25

Start date

2010-12-31

Completion date

2013-08-31

Last updated

2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Prevention of Hepatitis B infection., End Stage Renal Disease, Hepatitis B vaccination, Hepatitis B virus (HBV)

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

Interventions

BIOLOGICALHEPLISAV

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.

BIOLOGICALEngerix-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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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	Baseline
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL	6 months

Secondary

Measure	Time frame
To evaluate the safety of HEPLISAV and Engerix-B in CKD subjects who previously received at least one hepatitis B vaccine series.	Baseline and 6,12, 24, 36 and 48 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026