Hepatitis BPhase 1BOOST-9NCT04843852
TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
A Phase 1 study testing Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B] in people with Hepatitis B and Chronic Hepatitis B, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic Hepatitis B
- What is being tested?
- Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to 1 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute of Human Virology, University of Maryland School of Medicine
Baltimore, Maryland, 21201
Lydia Tang, MBChB, (410) 706-6567, LydiaTang@IHV.umaryland.edu
Lisa Anderson, RN, BS, 4107064069, lisa.anderson@ihv.umaryland.edu
About this study
Official title: Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response
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:
- Is HEPLISAV-B safe in people with chronic hepatitis B?
- What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B?
- How does HEPLISAV-B affect the cells that fight chronic hepatitis B?
Read more
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.
Read the detailed description
Ten people with chronic hepatitis B and virally suppressed on nucleos(t)ide analogue (NUC) therapy will receive a total of two 0.5ml intramuscular injections of HEPLISAV-B, a CpG-adjuvanted vaccine, the first injection on day 0, and the second injection on week 4.
Participants will visit the clinic on day 0, and weeks 2, 4, 8, and 28. They will also have phone follow ups on day 7, and weeks 5 and 56. At each follow up, participants will be asked about any side effects. At each clinic visit blood samples will be collected. For 7 days after each HEPLISAV-B injection, participants will complete a diary to document any reactions to the injection.
- Conditions
- Hepatitis B, Chronic Hepatitis B
- Being tested
- Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]
- Keywords
- hepatitis B, Toll-like receptor, vaccine, hepatitis B surface antibody, HBsAb, anti-HBsAg, hepatitis B surface antigen, HBsAg, TLR9, CpG
- Medical subject headings
- Hepatitis B, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]Drug
one 0.5ml intramuscular injection on day 0 and week 4.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | HEPLISAV-B is available in pre-filled, single-dose 0.5 mL vials. Each dose contains 20 μg of HBsAg and 3,000 μg of 1018 adjuvant. HEPLISAV-B is administered as an intramuscular injection in the deltoid region.
Study subjects will receive a total of 2 injections, each administered at least 4 weeks apart - the same dosing schedule recommended for hepatitis B prevention.
Once enrolled, participants will have study visits on days 0 (first injection), and weeks 2, 4 (second injection), 8, and 28. They will also have phone follow ups on day 7 and week 5 (7 days after each injection) and week 56 (end of study). Receives: Drug: Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 7 days following each vaccine dose
Occurence of unsolicited adverse events
Number of unsolicited adverse events
Measured: from dose 1 to 28 days following each vaccine dose
Medically Attended Adverse Events
Number of Medically Attended Adverse Events (MAAEs)
Measured: From first vaccine to 12 months after last vaccine on study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start16 Oct 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Tang, University of Maryland, Baltimore
- Investigators
- Lydia Tang, MBChB, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843852
- Sponsor's protocol ID
- HP-00115083
- Acronym
- BOOST-9
- Status last verified
- Oct 2025
- First submitted
- 6 Apr 2021
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response
- ClinicalTrials.gov ID
- NCT04843852
- Acronym / sponsor ID
- BOOST-9 / HP-00115083
- Conditions
- Hepatitis B, Chronic Hepatitis B
- Keywords
- hepatitis B, Toll-like receptor, vaccine, hepatitis B surface antibody, HBsAb, anti-HBsAg, hepatitis B surface antigen, HBsAg
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is HEPLISAV-B safe in people with chronic hepatitis B?
- What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B?
- 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.
Detailed description
Ten people with chronic hepatitis B and virally suppressed on nucleos(t)ide analogue (NUC) therapy will receive a total of two 0.5ml intramuscular injections of HEPLISAV-B, a CpG-adjuvanted vaccine, the first injection on day 0, and the second injection on week 4.
Participants will visit the clinic on day 0, and weeks 2, 4, 8, and 28. They will also have phone follow ups on day 7, and weeks 5 and 56. At each follow up, participants will be asked about any side effects. At each clinic visit blood samples will be collected. For 7 days after each HEPLISAV-B injection, participants will complete a diary to document any reactions to the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]HEPLISAV-B is available in pre-filled, single-dose 0.5 mL vials. Each dose contains 20 μg of HBsAg and 3,000 μg of 1018 adjuvant. HEPLISAV-B is administered as an intramuscular injection in the deltoid region. Study subjects will receive a total of 2 injections, each administered at least 4 weeks apart - the same dosing schedule recommended for hepatitis B prevention. Once enrolled, participants will have study visits on days 0 (first injection), and weeks 2, 4 (second injection), 8, and 28. They will also have phone follow ups on day 7 and week 5 (7 days after each injection) and week 56 (end of study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]one 0.5ml intramuscular injection on day 0 and week 4. | Drug | Intervention |
Primary outcome
Safety and reactogenicity of the Hepatitis B Virus Surface Antigen, Recombinant (HEPLISAV-B; Dynavax Technologies Corporation) Vaccine in patients with chronic hepatitis B
Time frame: Baseline to 7 days following each vaccine dose
Number of local and systemic solicited adverse events
Occurence of unsolicited adverse events
Time frame: from dose 1 to 28 days following each vaccine dose
Number of unsolicited adverse events
Medically Attended Adverse Events
Time frame: From first vaccine to 12 months after last vaccine on study.
Number of Medically Attended Adverse Events (MAAEs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lydia Tang, MBChB principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B] in people with Hepatitis B and Chronic Hepatitis B, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lydia Tang, MBChB ((410) 706-6567, LydiaTang@IHV.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and reactogenicity of the Hepatitis B Virus Surface Antigen, Recombinant (HEPLISAV-B; Dynavax Technologies Corporation) Vaccine in patients with chronic hepatitis B (time frame: Baseline to 7 days following each vaccine dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025; AzTrials last refreshed its copy on 1 Nov 2026.