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

• ClinicalTrials.gov Identifier: NCT03934736
• Recruitment Status: Unknown
• First Posted: May 2, 2019
• Last Update Posted: December 17, 2020
• Sponsor: Dynavax Technologies Corporation
• Information provided by (Responsible Party): Dynavax Technologies Corporation

Study Description

Brief Summary:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 119 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: October 23, 2020
• Estimated Study Completion Date: September 2021

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. Safety evaluation of clinically significant adverse events [ Time Frame: Monitor for safety until Week 68 or EOS ]
   To evaluate the proportion of subjects with treatment-emergent medically-attended adverse events (MAEs), serious adverse events (SAEs), immune-mediated adverse events of special interest (AESIs), acute myocardial infarctions (AMIs), and deaths
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 ]
   To evaluate the immunogenicity induced by HEPLISAV-B® as measured by the percentage of subjects with anti-HBs concentration ≥100 mIU/mL
2. Evaluation of immunogenicity [ Time Frame: Weeks 4, 8, 16, 20 ]
   To evaluate the immunogenicity induced by HEPLISAV-B® as measured by the serum anti-HBs geometric mean concentration (GMC)
3. Evaluation of immunogenicity [ Time Frame: Weeks 4, 8, 16, 20 ]
   To evaluate the immunogenicity induced by HEPLISAV-B® at each study visit through 20 weeks after the first dose of study vaccine as measured by the SPR

Eligibility Criteria

• 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. 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

Contacts and Locations

Locations

United States, Connecticut

DaVita Clinical Research or Affiliate

Bloomfield, Connecticut, United States, 06002

DaVita Clinical Research or Affiliate

Middlebury, Connecticut, United States, 06762

United States, Florida

DaVita Clinical Research or Affiliate

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

United States, Indiana

DaVita Clinical Research or Affiliate

Jeffersonville, Indiana, United States, 47130

United States, Michigan

DaVita Clinical Research or Affiliate

Roseville, Michigan, United States, 48066

United States, Minnesota

DaVita Clinical Research or Affiliate

Edina, Minnesota, United States, 55435

DaVita Clinical Research or Affiliate

Minneapolis, Minnesota, United States, 55404

United States, Missouri

DaVita Clinical Research or Affiliate

Kansas City, Missouri, United States, 64111

United States, Nevada

DaVita Clinical Research or Affiliate

Las Vegas, Nevada, United States, 89106

United States, New York

DaVita Clinical Research or Affiliate

Bronx, New York, United States, 10461

United States, North Carolina

DaVita Clinical Research or Affiliate

Asheville, North Carolina, United States, 28801

United States, Ohio

DaVita Clinical Research or Affiliate

Canton, Ohio, United States, 44718

United States, Pennsylvania

DaVita Clinical Research or Affiliate

Philadelphia, Pennsylvania, United States, 19106

United States, Texas

DaVita Clinical Research or Affiliate

El Paso, Texas, United States, 79902

DaVita Clinical Research or Affiliate

San Antonio, Texas, United States, 78229

United States, Virginia

DaVita Clinical Research or Affiliate

Norfolk, Virginia, United States, 23510

United States, Wisconsin

DaVita Clinical Research or Affiliate

Milwaukee, Wisconsin, United States, 53227

Sponsors and Collaborators

Dynavax Technologies Corporation

Investigators

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

More Information

• Responsible Party: Dynavax Technologies Corporation
• ClinicalTrials.gov Identifier: NCT03934736
• Other Study ID Numbers: DV2-HBV-24
• First Posted: May 2, 2019
• Last Update Posted: December 17, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Hepatitis B; Hepatitis, Viral, Human; Hepatitis; Kidney Diseases; Kidney Failure, Chronic; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Liver Diseases; Digestive System Diseases