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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT01282762
First received: January 20, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Biological: HEPLISAV
Biological: Engerix-B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of HEPLISAV and Engerix-B in CKD subjects who previously received at least one hepatitis B vaccine series. [ Time Frame: Baseline and 6,12, 24, 36 and 48 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Serum retained during study duration for additional testing if indicated


Enrollment: 147
Study Start Date: December 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

    Other Name: Hepatitis B vaccine (recombinant), adjuvanted
    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

    Other Name: Hepatitis B vaccine (recombinant)
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282762

Locations
United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Dynavax Technologies Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT01282762     History of Changes
Other Study ID Numbers: DV2-HBV-19
Study First Received: January 20, 2011
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Ministry of Health

Keywords provided by Dynavax Technologies Corporation:
Prevention of Hepatitis B infection.
End Stage Renal Disease
Hepatitis B vaccination
Hepatitis B virus (HBV)

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on October 01, 2014