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HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

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ClinicalTrials.gov Identifier: NCT03934736
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Brief Summary:
This will be an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease on Dialysis (Diagnosis) Drug: HEPLISAV-B® Phase 1

Detailed Description:
Eligible participants will receive single doses of HEPLISAV-B® at Weeks 0, 4, 8, and 16 and will be followed through Week 68 or end of study (EOS). The study is designed to evaluate the immunogenicity and safety over a 68-week period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HEPLISAV-B®
A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3) and Week 16 (Visit 4)
Drug: HEPLISAV-B®
HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).




Primary Outcome Measures :
  1. Safety evaluation of clinically significant adverse events [ Time Frame: Monitor for safety until Week 68 or EOS ]
    To evaluate the rate of medically-attended adverse events (MAEs), serious adverse events (SAEs), and immune-mediated adverse events of special interest (AESIs).

  2. Evaluation of seroprotection rate (SPR) [ Time Frame: Week 20 ]
    To evaluate the immunogenicity induced by HEPLISAV-B® when administered according to the proposed dosing schedule, as measured by the SPR, defined as antibody to hepatitis B surface antigen (anti-HBs) ≥ 10 mIU/mL


Secondary Outcome Measures :
  1. Evaluation of immunogenicity [ Time Frame: Weeks 4, 8, 16, 20, 24, 28, 52, 68 ]
    To evaluate the immunogenicity induced by HEPLISAV-B® as measured by the serum anti-HBs geometric mean concentration (GMC) on hemodialysis



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects at least 18 years of age
  • Laboratory confirmed negative serology result to hepatitis B virus (HBV) surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc) prior to first study injection
  • Must be clinically stable and in the opinion of the investigator able to comply with all study procedures
  • Must be able and willing to provide informed consent
  • Receiving hemodialysis or will initiate hemodialysis within 4 weeks of first study injection
  • Women of childbearing potential (WOCBP) must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening visit through 4 weeks after the last dose of study injection

Exclusion Criteria:

  • Previous receipt of any hepatitis B vaccine
  • History of human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection or antibody to HIV or HCV
  • History of sensitivity to any component of study vaccine
  • Has substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results
  • Recent or ongoing history of febrile illness (within 7 days of the first study injection)
  • Has received any of the following prior to the first study injection:

    • Within 14 days:

      a. Any inactivated vaccine

    • Within 28 days:

      1. Systemic corticosteroids (more than 3 consecutive days) or other immunomodulatory or immune suppressive medication with the exception of inhaled steroids
      2. Any live virus vaccine
      3. Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
      4. Any other investigational medicinal agent
    • Within 90 days:

      1. Blood products or immunoglobulin
  • If female and pregnant, nursing, or planning to become pregnant during the study
  • Undergoing chemotherapy or expected to receive chemotherapy during the study period
  • Has a medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments, including the following laboratory abnormalities which the investigator may consider if severe:

    • Anemia
    • Thrombocytopenia
    • Leukocytosis
    • Neutropenia
    • Metabolic acidosis
    • Increased alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
    • Hyperkalemia
    • Hypokalemia
  • Is scheduled to undergo a kidney transplant within 6 months of the first study injection

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): NCT03934736


Contacts
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Contact: Michael Kritschgau 855-327-7883 mk@davita.com

Locations
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United States, California
DaVita Clinical Research or Affiliate Recruiting
Corona, California, United States, 92881
DaVita Clinical Research or Affiliate Recruiting
Riverside, California, United States, 92501
DaVita Clinical Research or Affiliate Recruiting
Whittier, California, United States, 90606
United States, Connecticut
DaVita Clinical Research or Affiliate Recruiting
Bloomfield, Connecticut, United States, 06002
DaVita Clinical Research or Affiliate Recruiting
Middlebury, Connecticut, United States, 06762
United States, Florida
DaVita Clinical Research or Affiliate Recruiting
Hollywood, Florida, United States, 33021
DaVita Clinical Research or Affiliate Recruiting
Ocala, Florida, United States, 34471
DaVita Clinical Research or Affiliate Recruiting
Tampa, Florida, United States, 33614
DaVita Clinical Research or Affiliate Recruiting
Winter Park, Florida, United States, 32789
United States, Indiana
DaVita Clinical Research or Affiliate Recruiting
Jeffersonville, Indiana, United States, 47130
United States, Minnesota
DaVita Clinical Research or Affiliate Recruiting
Edina, Minnesota, United States, 55435
DaVita Clinical Research or Affiliate Recruiting
Minneapolis, Minnesota, United States, 55404
United States, Missouri
DaVita Clinical Research or Affiliate Recruiting
Kansas City, Missouri, United States, 64111
United States, Nevada
DaVita Clinical Research or Affiliate Recruiting
Las Vegas, Nevada, United States, 89106
United States, New York
DaVita Clinical Research or Affiliate Recruiting
Bronx, New York, United States, 10461
United States, North Carolina
DaVita Clinical Research or Affiliate Recruiting
Asheville, North Carolina, United States, 28801
United States, Ohio
DaVita Clinical Research or Affiliate Recruiting
Canton, Ohio, United States, 44718
United States, Pennsylvania
DaVita Clinical Research or Affiliate Recruiting
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
DaVita Clinical Research or Affiliate Recruiting
El Paso, Texas, United States, 79902
DaVita Clinical Research or Affiliate Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
DaVita Clinical Research or Affiliate Recruiting
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Dynavax Technologies Corporation
Investigators
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Study Director: Randall N Hyer, MD, PhD, MPH Dynavax Technologies Corporation

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Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT03934736     History of Changes
Other Study ID Numbers: DV2-HBV-24
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dynavax Technologies Corporation:
ESRD
Hemodialysis
End Stage Renal Disease
Hepatitis B
HEPLISAV-B
Prevention and Control
HBV Vaccine
Hepatitis B Vaccine
Additional relevant MeSH terms:
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Hepatitis B
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs