TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
Recruiting · NCT04843852 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Maryland, Baltimore
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- In order to participate in this study, an individual must meet all the following criteria:
- \>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.
- Determined by medical history, targeted physical examination, and clinical judgement of the investigator to be in good health.
- CHB infection is defined as any individual with documentation of a positive HBsAg and/or detectable HBV DNA test for at least 6 months.
Exclusion criteria
- A participant will be ineligible to participate on this study if any of the following criteria are met:
- 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.
- Participation in a study with an investigational study product or device within 30 days of randomization.
- Has allergies to any hepatitis B and/or yeast-based vaccines.
- Subjects meeting any of the following laboratory parameters at screening:
- ALT greater than 3 times the upper limit of normal
- Elevated total bilirubin WITH direct bilirubin greater than 2 times upper limit of normal
- Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as ≥ 38.0°C/100.4°F). Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- Have any chronic or acute or unstable conditions that the investigator considers a contraindication to study participation.
Where it is running
1 location listed across 1 US state.
- Institute of Human Virology, University of Maryland School of Medicine - Baltimore, Maryland, United States