Clinical trial NCT03934736: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End Stage Renal Disease on Hemodialysis (Diagnosis)
Keywords: ESRD
Hemodialysis
End Stage Renal Disease
Hepatitis B
HEPLISAV-B
Prevention and Control
HBV Vaccine
Hepatitis B Vaccine
HEPLISAV
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2019-05-02
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

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. 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

Primary outcomes:
measure: Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
timeFrame: Week 0 (Visit 1) until Week 68 or early termination
measure: Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
timeFrame: Week 20
Secondary outcomes:
measure: Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL
timeFrame: Weeks 4, 8, 16, 20
measure: Serum Anti-HBsAg Geometric Mean Concentration (GMC)
timeFrame: Weeks 4, 8, 16, 20
measure: Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
timeFrame: Weeks 4, 8, 16, 20
Other outcomes:
Locations:
city: Bloomfield
country: United States
facility: DaVita Clinical Research or Affiliate
state: Connecticut
city: Middlebury
country: United States
facility: DaVita Clinical Research or Affiliate
state: Connecticut
city: Hollywood
country: United States
facility: DaVita Clinical Research or Affiliate
state: Florida
city: Ocala
country: United States
facility: DaVita Clinical Research or Affiliate
state: Florida
city: Tampa
country: United States
facility: DaVita Clinical Research or Affiliate
state: Florida
city: Winter Park
country: United States
facility: DaVita Clinical Research or Affiliate
state: Florida
city: Jeffersonville
country: United States
facility: DaVita Clinical Research or Affiliate
state: Indiana
city: Roseville
country: United States
facility: DaVita Clinical Research or Affiliate
state: Michigan
city: Edina
country: United States
facility: DaVita Clinical Research or Affiliate
state: Minnesota
city: Minneapolis
country: United States
facility: DaVita Clinical Research or Affiliate
state: Minnesota
city: Kansas City
country: United States
facility: DaVita Clinical Research or Affiliate
state: Missouri
city: Las Vegas
country: United States
facility: DaVita Clinical Research or Affiliate
state: Nevada
city: Bronx
country: United States
facility: DaVita Clinical Research or Affiliate
state: New York
city: Asheville
country: United States
facility: DaVita Clinical Research or Affiliate
state: North Carolina
city: Canton
country: United States
facility: DaVita Clinical Research or Affiliate
state: Ohio
city: Philadelphia
country: United States
facility: DaVita Clinical Research or Affiliate
state: Pennsylvania
city: El Paso
country: United States
facility: DaVita Clinical Research or Affiliate
state: Texas
city: San Antonio
country: United States
facility: DaVita Clinical Research or Affiliate
state: Texas
city: Norfolk
country: United States
facility: DaVita Clinical Research or Affiliate
state: Virginia
city: Milwaukee
country: United States
facility: DaVita Clinical Research or Affiliate
state: Wisconsin
Study officials:
affiliation: Dynavax Technologies Corporation
name: Robert Janssen, MD
role: STUDY_CHAIR
References: