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

End Stage Renal Disease on Dialysis (Diagnosis) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03934736
• Other study ID #: DV2-HBV-24
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 29, 2019
• Est. completion date: September 2021

Study information

• Verified date: December 2020
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: September 2021
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis (Diagnosis)
• Hepatitis B
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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).

Locations

Country	Name	City	State
United States	DaVita Clinical Research or Affiliate	Asheville	North Carolina
United States	DaVita Clinical Research or Affiliate	Bloomfield	Connecticut
United States	DaVita Clinical Research or Affiliate	Bronx	New York
United States	DaVita Clinical Research or Affiliate	Canton	Ohio
United States	DaVita Clinical Research or Affiliate	Edina	Minnesota
United States	DaVita Clinical Research or Affiliate	El Paso	Texas
United States	DaVita Clinical Research or Affiliate	Hollywood	Florida
United States	DaVita Clinical Research or Affiliate	Jeffersonville	Indiana
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	Middlebury	Connecticut
United States	DaVita Clinical Research or Affiliate	Milwaukee	Wisconsin
United States	DaVita Clinical Research or Affiliate	Minneapolis	Minnesota
United States	DaVita Clinical Research or Affiliate	Norfolk	Virginia
United States	DaVita Clinical Research or Affiliate	Ocala	Florida
United States	DaVita Clinical Research or Affiliate	Philadelphia	Pennsylvania
United States	DaVita Clinical Research or Affiliate	Roseville	Michigan
United States	DaVita Clinical Research or Affiliate	San Antonio	Texas
United States	DaVita Clinical Research or Affiliate	Tampa	Florida
United States	DaVita Clinical Research or Affiliate	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluation of clinically significant adverse events	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	Monitor for safety until Week 68 or EOS
Primary	Evaluation of seroprotection rate (SPR)	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	Week 20
Secondary	Evaluation of immunogenicity	To evaluate the immunogenicity induced by HEPLISAV-B® as measured by the percentage of subjects with anti-HBs concentration =100 mIU/mL	Weeks 4, 8, 16, 20
Secondary	Evaluation of immunogenicity	To evaluate the immunogenicity induced by HEPLISAV-B® as measured by the serum anti-HBs geometric mean concentration (GMC)	Weeks 4, 8, 16, 20
Secondary	Evaluation of immunogenicity	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	Weeks 4, 8, 16, 20