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
1 other identifier
observational
147
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMarch 20, 2019
March 1, 2019
2.7 years
January 20, 2011
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
12 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
24 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
36 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
48 months
Secondary Outcomes (1)
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
Interventions
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.
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
Eligibility Criteria
Subjects with Chronic Kidney Disease previously enrolled in the Dynavax clinical studies DV2-HBV-17 and DV2-HBV-18
You may qualify 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Related Publications (1)
Girndt M, Houser P, Manllo-Karim R, Ervin JE, Charytan C, Chow S, Symonian-Silver M, Lehrner L, Linfert D, Shemin D, Michelsen A, Xie F, Janssen RS. Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease. Vaccine. 2023 May 11;41(20):3224-3232. doi: 10.1016/j.vaccine.2023.04.028. Epub 2023 Apr 19.
PMID: 37085451DERIVED
Related Links
Biospecimen
Serum retained during study duration for additional testing if indicated
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 25, 2011
Study Start
December 1, 2010
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
March 20, 2019
Record last verified: 2019-03