TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
The goal of this clinical trial is to learn if HEPLISAV-B, a vaccine that is approved to prevent hepatitis B infection in people that are not already infected, is safe in people already chronically infected with hepatitis B. The main quiestions it aims to answer are:
1. Is HEPLISAV-B safe in people with chronic hepatitis B? 2. What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B? 3. How does HEPLISAV-B affect the cells that fight chronic hepatitis B?
Participants will:
* Receive HEPLISAV-B as an injection in the muscle, one injection every 4 weeks, for a total of 2 injections. * Visit the clinic a total of 5 times, and have 3 phone follow ups over 14 months. * Be asked if they are having any side effects from HEPLISAV-B. * Have blood samples collected.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>18 years old
Diagnosed with CHB infection, without HIV, hepatitis C nor hepatitis D co-infections
Currently receiving NUC with HBV VL <100 IU/ml for ≥ 12 months
Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
Disqualifiers
Pregnancy or breast feeding.
Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Received anti-CD20 immunosuppressant within 12 months of screening. Topical tacrolimus is allowed if not used within 14 days prior to Day 1.
Received or plans to receive live virus vaccines within 4 weeks, and inactivated vaccine within 2 weeks prior to randomization; or plans to receive a non-study vaccine within 28 days after any dose of study vaccine (with exception for seasonal influenza vaccine within 14 days of study vaccine).
Administration of any blood products within 3 months prior to randomization.
Trial design
Design model
Single group
Treatments tested in this trial
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]
Drugone 0.5ml intramuscular injection on day 0 and week 4.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and reactogenicity of the Hepatitis B Virus Surface Antigen, Recombinant (HEPLISAV-B; Dynavax Technologies Corporation) Vaccine in patients with chronic hepatitis B
Number of local and systemic solicited adverse events
Time frame
Baseline to 7 days following each vaccine dose2
Occurence of unsolicited adverse events
Number of unsolicited adverse events
Time frame
from dose 1 to 28 days following each vaccine dose3
Medically Attended Adverse Events
Number of Medically Attended Adverse Events (MAAEs)
Time frame
From first vaccine to 12 months after last vaccine on study.Other outcomes
1
Change in hepatitis B surface antigen levels
Hepatitis B surface antigen levels (international units per milliliter, IU/mL) will be measured at baseline, and thoughout study
Time frame
Day 0 to week 282
Anti-HBsAg Seroconversion
Number of patients with anti-HBsAg seroconversion
Time frame
Day 0 through 12 months post vaccination3
Changes in immunologic and virologic responses throughout study
Change in hepatitis B surface antigen-specific immune cell types (percentage of cells) and function (percentage of cells producing cytokines), and hepatitis B virus viral markers (international units per milliliter, IU/mL) will be evaluated at baseline, and throughout the study.
Time frame
baseline to week 28Sponsors and contacts
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Source ClinicalTrials.gov