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New treatment option for Hepatitis B
Official title TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
ClinicalTrials.gov ID: NCT04843852
What this study is testing
What is Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]?
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B] is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hepatitis b.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 14 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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.
- people 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...
- Have any chronic or acute or unstable conditions that the investigator considers a contraindication to study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 14 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.