HEPLISAV-B Vaccine for Chronic Hepatitis B

(BOOST-9 Trial)

Recruiting at 1 trial location

Overseen By Lydia Tang, MBChB

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Maryland, Baltimore

Must be taking: NUC

Must not be taking: Immunosuppressants, Immune-modifying drugs

Disqualifiers: Pregnancy, HIV, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the HEPLISAV-B vaccine, typically used to prevent hepatitis B, is safe for individuals with chronic hepatitis B. Researchers are monitoring any side effects and assessing how the vaccine impacts immune cells fighting the infection. Individuals who have managed chronic hepatitis B for over a year and are not co-infected with HIV or other hepatitis strains may be suitable candidates for this trial. Participants will receive two injections and must visit the clinic several times over 14 months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, you must be on a stable treatment for hepatitis B with a low viral load for at least 12 months to participate.

Is there any evidence suggesting that HEPLISAV-B is likely to be safe for people with chronic hepatitis B?

Research has shown that HEPLISAV-B, a vaccine to prevent hepatitis B, is generally safe when used as intended. The vaccine is already approved for individuals without hepatitis B. Studies have found that common side effects include mild reactions, such as soreness at the injection site and fatigue, while serious reactions are rare.

This trial examines the vaccine's safety for individuals with long-term hepatitis B. Although HEPLISAV-B is commonly used to prevent the disease, using it in this new context requires monitoring for different side effects. Those who have experienced a severe allergic reaction to a vaccine should inform the trial team. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for chronic hepatitis B?

Unlike the standard hepatitis B vaccines that typically require three doses over six months, HEPLISAV-B is unique because it delivers protection with just two doses one month apart. This difference comes from its novel adjuvant, 1018, which enhances the immune response more efficiently. Researchers are excited about HEPLISAV-B because it promises quicker protection against hepatitis B, potentially improving patient compliance and public health outcomes.

What evidence suggests that HEPLISAV-B might be an effective treatment for chronic hepatitis B?

Research has shown that HEPLISAV-B is a highly effective vaccine for preventing hepatitis B. One study provided 95% protection after just two doses for adults aged 18 to 55. This vaccine creates a strong immune response, helping to guard against hepatitis B infection. Although approved for prevention, this trial will examine its effects on individuals with chronic hepatitis B. Early findings suggest potential benefits due to its immune-boosting properties, but further research is needed to confirm this for those with chronic hepatitis B. ^{2 3 6 7 8}

Who Is on the Research Team?

Lydia Tang, MBChB

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for individuals with chronic hepatitis B who are in good health, have been on oral antiviral therapy with a viral load under 100 IU/ml for at least 12 months, and do not have HIV, hepatitis C or D. They must be willing to follow the study schedule.

Inclusion Criteria

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.

I have tested positive for hepatitis B.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two intramuscular injections of HEPLISAV-B, one on day 0 and another on week 4

4 weeks

5 visits (in-person), 3 visits (phone follow-up)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with clinic visits and phone follow-ups

12 months

2 visits (in-person), 1 visit (phone follow-up)

What Are the Treatments Tested in This Trial?

Interventions

• Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]

Trial Overview The trial tests HEPLISAV-B vaccine's safety in those already infected with chronic hepatitis B. Participants will receive two injections of the vaccine over four weeks and attend five clinic visits plus three phone check-ups over 14 months.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. heplisavbhcp.com heplisavbhcp.com/heplisav-b-study-results/

Study Results - HEPLISAV-B® (Recombinant), Adjuvanted Higher rates of protection with HEPLISAV‑B · In a pivotal study of adults aged 18–55, 95% of those who received HEPLISAV‑B were protected after only 2 doses in 1 ...

2. fda.gov fda.gov/media/108745/download

Package Insert - HEPLISAV-B Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9802290/

Cost-Effectiveness of an Adjuvanted Hepatitis B Vaccine ... Changing Engerix-B to HEPLISAV-B in a hypothetical group of 100,000 patients prevented 6 and 30 cases of acute hepatitis; and 4 and 5 cases of chronic hepatitis ...

4. cdc.gov cdc.gov/acip/grade/hepb.html

HEPLISAV-B | ACIP Based on the available immunogenicity evidence, a 2-dose schedule (0, 1 month) of HepB-CpG will be efficacious for the prevention of HBV infection.

5. heplisavb.com heplisavb.com/

Hepatitis B Vaccine - HEPLISAV-B® (Recombinant), Adjuvanted HEPLISAV-B provides protection with 2 doses in 1 month. The first and only adult hepatitis B vaccine that is only 2 doses in 1 month.

6. medicomart.com medicomart.com/images/document/BRK-SDS-0009%20HEPLISAV-B%E2%84%A2%20[Hepatitis%20B%20Vaccine%20(Recombinant),%20Adjuvanted].pdf

BRK-SDS-0009 HEPLISAV-B™ [Hepatitis B Vaccine ( ... This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace. It is ...

7. heplisavbhcp.com heplisavbhcp.com/heplisav-b-safety-profile/

Safety Profile - HEPLISAV-B® (Recombinant), Adjuvanted Do not administer HEPLISAV‑B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to ...

8. hhs.texas.gov hhs.texas.gov/sites/default/files/documents/doing-business-with-hhs/provider-portal/facilities-regulation/psychiatric/monograph/hepatitis-b-vaccine-recombinant-heplisav-b-monograph.pdf

Hepatitis B Vaccine Recombinant, Adjuvant (HEPLISAV-B) 6 Until safety data is available for Heplisav-B, providers should continue to vaccinate pregnant women needing Hepatitis B Vaccine with Hep-B-Alum. (ENGERIX-B® ...