Overview
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2021-09-01
2021-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Dynavax Technologies CorporationTreatments:
Vaccines
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