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

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

Tracking Information

• First Submitted Date: February 11, 2019
• First Posted Date: May 2, 2019
• Last Update Posted Date: May 9, 2019
• Actual Study Start Date: April 29, 2019
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: End Stage Renal Disease on Dialysis (Diagnosis)

Intervention

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

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 29, 2019): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2021
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03934736
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Dynavax Technologies Corporation
• Study Sponsor: Dynavax Technologies Corporation
• Collaborators: Not Provided

Investigators

• Study Director: Randall N Hyer, MD, PhD, MPH; Dynavax Technologies Corporation

• PRS Account: Dynavax Technologies Corporation
• Verification Date: May 2019