HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
NCT ID: NCT03934736
Last Updated: 2024-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
119 participants
INTERVENTIONAL
2019-04-22
2021-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Dynavax Technologies Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Janssen, MD
Role: STUDY_CHAIR
Dynavax Technologies Corporation
Locations
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DaVita Clinical Research or Affiliate
Bloomfield, Connecticut, United States
DaVita Clinical Research or Affiliate
Middlebury, Connecticut, United States
DaVita Clinical Research or Affiliate
Hollywood, Florida, United States
DaVita Clinical Research or Affiliate
Ocala, Florida, United States
DaVita Clinical Research or Affiliate
Tampa, Florida, United States
DaVita Clinical Research or Affiliate
Winter Park, Florida, United States
DaVita Clinical Research or Affiliate
Jeffersonville, Indiana, United States
DaVita Clinical Research or Affiliate
Roseville, Michigan, United States
DaVita Clinical Research or Affiliate
Edina, Minnesota, United States
DaVita Clinical Research or Affiliate
Minneapolis, Minnesota, United States
DaVita Clinical Research or Affiliate
Kansas City, Missouri, United States
DaVita Clinical Research or Affiliate
Las Vegas, Nevada, United States
DaVita Clinical Research or Affiliate
The Bronx, New York, United States
DaVita Clinical Research or Affiliate
Asheville, North Carolina, United States
DaVita Clinical Research or Affiliate
Canton, Ohio, United States
DaVita Clinical Research or Affiliate
Philadelphia, Pennsylvania, United States
DaVita Clinical Research or Affiliate
El Paso, Texas, United States
DaVita Clinical Research or Affiliate
San Antonio, Texas, United States
DaVita Clinical Research or Affiliate
Norfolk, Virginia, United States
DaVita Clinical Research or Affiliate
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DV2-HBV-24
Identifier Type: -
Identifier Source: org_study_id
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