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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282762
• Other study ID #: DV2-HBV-19
• Status: Completed
• Start date: December 2010
• Est. completion date: August 2013

Study information

• Verified date: March 2019
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hepatitis B
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• 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.
• 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

Locations

Country	Name	City	State
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL		6 months
Primary	To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL		12 months
Primary	To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL		24 months
Primary	To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL		36 months
Primary	To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL		48 months
Secondary	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

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