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

An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

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

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease on Hemodialysis (Diagnosis)
• Intervention / Treatment: Drug: HEPLISAV-B®

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 over a 20-week period and safety over a 68-week period.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bloomfield, Connecticut, United States, 06002
      • DaVita Clinical Research or Affiliate
    • Middlebury, Connecticut, United States, 06762
      • DaVita Clinical Research or Affiliate
  • Florida
    • Hollywood, Florida, United States, 33021
      • DaVita Clinical Research or Affiliate
    • Ocala, Florida, United States, 34471
      • DaVita Clinical Research or Affiliate
    • Tampa, Florida, United States, 33614
      • DaVita Clinical Research or Affiliate
    • Winter Park, Florida, United States, 32789
      • DaVita Clinical Research or Affiliate
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • DaVita Clinical Research or Affiliate
  • Michigan
    • Roseville, Michigan, United States, 48066
      • DaVita Clinical Research or Affiliate
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • DaVita Clinical Research or Affiliate
    • Minneapolis, Minnesota, United States, 55404
      • DaVita Clinical Research or Affiliate
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • DaVita Clinical Research or Affiliate
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • DaVita Clinical Research or Affiliate
  • New York
    • Bronx, New York, United States, 10461
      • DaVita Clinical Research or Affiliate
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • DaVita Clinical Research or Affiliate
  • Ohio
    • Canton, Ohio, United States, 44718
      • DaVita Clinical Research or Affiliate
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19106
      • DaVita Clinical Research or Affiliate
  • Texas
    • El Paso, Texas, United States, 79902
      • DaVita Clinical Research or Affiliate
    • San Antonio, Texas, United States, 78229
      • DaVita Clinical Research or Affiliate
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • DaVita Clinical Research or Affiliate
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53227
      • DaVita Clinical Research or Affiliate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. Acceptable birth control methods include but are not limited to oral contraceptive medication, an intrauterine device (IUD), an injectable contraceptive (such as medroxyprogesterone acetate or Depo-Provera®), a birth control patch, or a barrier method (such as condom or diaphragm with spermicide).

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 for adults 18 years of age and older, consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest	Proportion of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations.	Week 0 (Visit 1) until Week 68 or early termination
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response	SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B	Week 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL	Percentage of subjects with anti-HBs concentration ≥100 mIU/mL.	Weeks 4, 8, 16, 20
Serum Anti-HBsAg Geometric Mean Concentration (GMC)	Serum Anti-HBsAg Geometric Mean Concentration (GMC).	Weeks 4, 8, 16, 20
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response	SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B	Weeks 4, 8, 16, 20

Collaborators and Investigators

• Sponsor: Dynavax Technologies Corporation
• Investigators: Study Chair: Robert Janssen, MD, Dynavax Technologies Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; ESRD; Hepatitis B; Hemodialysis; Prevention and Control; Hepatitis B Vaccine; HEPLISAV-B; HBV Vaccine; HEPLISAV
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Urologic Diseases; Disease Attributes; Liver Diseases; Renal Insufficiency; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Renal Insufficiency, Chronic; Hepatitis; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Hepatitis B; Kidney Failure, Chronic
• Other Study ID Numbers: DV2-HBV-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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