TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B

Korábbi kezelés

• 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.
• 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.

Más betegség

• Has allergies to any hepatitis B and/or yeast-based vaccines.
• Have any chronic or acute or unstable conditions that the investigator considers a contraindication to study participation.

Laborértékek

• 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

Egyéb

• A participant will be ineligible to participate on this study if any of the following criteria are met:
• Pregnancy or breast feeding.
• Participation in a study with an investigational study product or device within 30 days of randomization.

• 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.