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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

Tracking Information
First Submitted Date  ICMJE February 11, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE April 29, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • 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).
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • Safety evaluation [ Time Frame: Monitor for safety until Week 68 or EOS ]
    To evaluate the safety of HEPLISAV-B® in participants with ESRD on hemodialysis with respect to clinically significant adverse events
  • 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
Change History Complete list of historical versions of study NCT03934736 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
Official Title  ICMJE An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE End Stage Renal Disease on Dialysis (Diagnosis)
Intervention  ICMJE 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).
Study Arms  ICMJE 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)
Intervention: Drug: HEPLISAV-B®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Kritschgau 855-327-7883 mk@davita.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03934736
Other Study ID Numbers  ICMJE DV2-HBV-24
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dynavax Technologies Corporation
Study Sponsor  ICMJE Dynavax Technologies Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Randall N Hyer, MD, PhD, MPH Dynavax Technologies Corporation
PRS Account Dynavax Technologies Corporation
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP