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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

119

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Apr 2019

Typical duration for phase_1

Geographic Reach

1 country

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

February 11, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed

10 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2020

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed

2.9 years until next milestone

Results Posted

Study results publicly available

August 9, 2024

Completed

Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

February 11, 2019

Results QC Date

June 8, 2022

Last Update Submit

August 5, 2024

Conditions

End Stage Renal Disease on Hemodialysis (Diagnosis)

Keywords

ESRDHemodialysisEnd Stage Renal DiseaseHepatitis BHEPLISAV-BPrevention and ControlHBV VaccineHepatitis B VaccineHEPLISAV

Outcome Measures

Primary Outcomes (2)

Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
Proportion of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations.
Week 0 (Visit 1) until Week 68 or early termination
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B
Week 20

Secondary Outcomes (3)

Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL
Weeks 4, 8, 16, 20
Serum Anti-HBsAg Geometric Mean Concentration (GMC)
Weeks 4, 8, 16, 20
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
Weeks 4, 8, 16, 20

Study Arms (1)

HEPLISAV-B®

EXPERIMENTAL

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®

Interventions

HEPLISAV-B®DRUG

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).

HEPLISAV-B®

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

You may not qualify if:

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:
Systemic corticosteroids (more than 3 consecutive days) or other immunomodulatory or immune suppressive medication with the exception of inhaled steroids
Any live virus vaccine
Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
Any other investigational medicinal agent
Within 90 days:
Blood products or immunoglobulin
+12 more criteria

Contact the study team to confirm eligibility.