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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282762
First Posted: January 25, 2011
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dynavax Technologies Corporation
  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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT01282762     History of Changes
Other Study ID Numbers: DV2-HBV-19
First Submitted: January 20, 2011
First Posted: January 25, 2011
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No Changes to status a/o 3/2017

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
Hepatitis B
Renal Insufficiency, Chronic
Urologic Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Renal Insufficiency
Vaccines
Immunologic Factors
Physiological Effects of Drugs