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Hepatitis BPhase 1NCT04199715

Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

A Phase 1 study testing Heplisav-B in people with Hepatitis B, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a preliminary trial of a Hepatitis B vaccine (Heplisav-B) in medically immunosuppressed patients. The purpose of this study is to test the ability of Heplisav-B to produce high levels of antibody that neutralize the virus and prevent hepatitis B from coming back. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B
What is being tested?
Heplisav-B
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
3 Dec 2019to 20 Jan 2022
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age 18 or older and agree to adhere to study requirements
  • Must be willing to provide informed consent
  • Serologic profile consistent with resolved hepatitis B (HBsAg negative but anti-HBc positive)
  • Must meet one of the following requirements: Recipient of anti-HBc positive liver (Group C), Chronic inflammatory disease requiring TNF or interleukin inhibitor therapy (Group A), Solid organ malignancy that requires systemic cancer chemotherapy (Group B), or Post liver transplant for chronic HBV infection (Group C).
  • Recipient of immunosuppressive drug medication as described above

Who cannot join

  • HBsAg positivity
  • Anti-HBs level > 20 mIU/mL at baseline
  • HIV infection
  • HCV infection
  • Prior hepatitis B vaccination
  • Received hepatitis B immune globulin during the past 4 months
Show all 17Show fewer
  • Hematologic malignancy
  • Hepatocellular carcinoma
  • Active alcohol use > 20 grams daily
  • Unstable underlying inflammatory disorder
  • Pregnancy or breast feeding
  • History of severe depression or other severe psychiatric disorder
  • Received liver transplant < 3 years earlier
  • Transplant rejection within the past year
  • Unstable or poorly responsive inflammatory disorders
  • Patients who have an unreasonable risk of complications
  • Anticipated life expectancy less than one year

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246

Other trials in United States

About this study

Official title: Immunologic Efficacy of Heplisav B Vaccine in Patients Undergoing Treatment With Immunosuppressive Medications

This is a preliminary trial of a Hepatitis B vaccine (Heplisav-B) in medically immunosuppressed patients. The purpose of this study is to test the ability of Heplisav-B to produce high levels of antibody that neutralize the virus and prevent hepatitis B from coming back. Another important purpose is to test the safety of this vaccine in patients taking immune suppressive medicines.

Read the detailed description

This is an open label exploratory study of the immunologic efficacy and safety of an FDA-approved Hepatitis B vaccine called Heplisav-B. It will be used in patients treated with long term immunosuppressive drug therapy. The patients will be given two doses of Heplisav-B, the first delivered at the baseline visit and the second at week 4. Antibody levels against the Hepatitis B virus will be measured at baseline and at weeks 4, 8, 12, 24 and 60. The proportion of those patients with protective antibody levels will be compared with non-immune compromised patients receiving the same dosing schedule. Patients who fail to demonstrate protective levels of antibodies at week 8 will be given a third booster dose at week 12, and all patients will be followed to week 60.

This research is being done because current alternative hepatitis B vaccines produce lower levels of antibody to hepatitis B, and the level of antibody can be important in the prevention of the virus coming back. However, administration of Heplisav-B has been associated with higher levels of protective antibody in healthy individuals, people with diabetes, and people with kidney disease. It is hoped that the same beneficial effect of higher antibody level will also occur in patients who take an immune suppressing medicine to treat underlying inflammatory disorder (either arthritis, colitis, or chronic skin inflammation), chemotherapy for cancer, or anti-rejection therapy for liver transplantation.

Conditions
Hepatitis B
Being tested
Heplisav-B
Keywords
Hepatitis B, Hep B, Vaccine, Immunosuppression, HBV
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heplisav-BBiological

    This is an FDA-approved vaccine for Hepatitis B that is made by Dynavax Technologies.

Study groups in NCT04199715
Study groupRoleWhat they receive
Heplisav-B Vaccine RecipientExperimentalThere will be a single group of 18 immune compromised patients who will receive the Heplisav-B vaccine.
Receives: Biological: Heplisav-B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of Heplisav-B Vaccine in Immunosuppressed Patients

    Patients will be followed for 60 weeks to capture adverse events. Safety will be determined by the proportion of patients with unsolicited adverse events after vaccine administration, the proportion of patients with serious adverse events, the proportion of patients with medically attended adverse events, the proportion of patients with potentially immune-mediated medical conditions, and the proportion of patients who need an increase in immune suppressive medication.

    Measured: 60 weeks

  2. Immunologic Efficacy of Heplisav-B Vaccine in Immunosuppressed Patients

    Efficacy will be determined by the proportion of patients who respond with seroprotective levels (> 10 mIU/ml) of anti-HBs at each study interval and the proportion of patients with anti-HBs titers > 100 mIU/ml at each study interval.

    Measured: 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2019
  2. Study start3 Dec 2019
  3. Primary completion20 Jan 2022
  4. Study completion20 Jan 2022

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
A total of 18 patients will be entered into the study including 3 evenly sized groups of 6 as follows: * Group A patients on tumor necrosis factor alpha or interleukin inhibitor therapy for underlying chronic inflammatory disorders * Group B patients on chemotherapy for solid organ malignancy * Group C patients are either recipients of livers from anti-HBc positive donors or are patients transplanted for chronic hepatitis B infection without recurrent hepatitis B at the time of enrollment
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04199715
Sponsor's protocol ID
IND 18850
Status last verified
Feb 2022
First submitted
12 Dec 2019
Last updated
11 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Schillie S, Vellozzi C, Reingold A, Harris A, Haber P, Ward JW, Nelson NP. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018 Jan 12;67(1):1-31. doi: 10.15585/mmwr.rr6701a1.

    PubMed 29939980

  • Paul S, Dickstein A, Saxena A, Terrin N, Viveiros K, Balk EM, Wong JB. Role of surface antibody in hepatitis B reactivation in patients with resolved infection and hematologic malignancy: A meta-analysis. Hepatology. 2017 Aug;66(2):379-388. doi: 10.1002/hep.29082. Epub 2017 Jun 22.

    PubMed 28128861

  • Splawn LM, Bailey CA, Medina JP, Cho JC. Heplisav-B vaccination for the prevention of hepatitis B virus infection in adults in the United States. Drugs Today (Barc). 2018 Jul;54(7):399-405. doi: 10.1358/dot.2018.54.7.2833984.

    PubMed 30090877

  • Perrillo R, Garrido LF, Ma TW, Rahimi R, Lilly B. Vaccination with HepB-CpG vaccine in individuals undergoing immune suppressive drug therapy. Vaccine. 2023 Jul 12;41(31):4457-4461. doi: 10.1016/j.vaccine.2023.06.041. Epub 2023 Jun 21.

    PubMed 37353450

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Heplisav-B in people with Hepatitis B, run by Baylor Research Institute 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 11 Mar 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of Heplisav-B Vaccine in Immunosuppressed Patients (time frame: 60 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04199715, which also lists 4 linked publications.

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 11 Mar 2022.

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