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DELIVER THE POWER OF 3

PreHevbrio® is the Only 3-Antigen Hepatitis B Vaccine

PreHevbrio is an FDA-approved vaccine indicated for the prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

Hepatitis B virus (HBV) continues to be a serious public health threat

The Department of Health and Human Services (HHS) estimates that as many as

2.2m people

are chronically infected with HBV1

HBV is up to

100x more

infectious than HIV2

only 30%

of adults are vaccinated against HBV in the U.S., leaving the large majority at risk of HBV infection4

Improved immunogenicity may be needed in certain adult subpopulations.5,6

Notable high-risk groups include:

Advanced Age

Diabetes

High BMI

Immunosuppression

In April 2022, the CDC’s Advisory Committee on Immunization Practices (ACIP) published new guidance on recommendations for adult vaccination against hepatitis B, including a universal recommendation for adults age 19-59 years

You can help protect more patients in your practice against HBV infection

See how PreHevbrio, the only 3-antigen HBV vaccine, delivers the Power of 3

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Indication & Important Safety Info
INDICATION

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

IMPORTANT SAFETY INFORMATION

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

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INDICATION

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

IMPORTANT SAFETY INFORMATION

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact medinfo@vbivaccines.com or call 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov

Please see Full Prescribing Information.

References
1. HHS. Viral Hepatitis in the United States: Data and Trends. https://www.hhs.gov/hepatitis/learn-about-viral-hepatitis/data-and-trends/index.html; Accessed November 2021.
2. Hepatitis B & Sexual Health – Centers for Disease Control and Prevention. Accessed November 5, 2021. https://www.cdc.gov/hepatitis/hbv/pdfs/HepBSexualHealth.pdf.
3. Hepatitis B Basic Information U.S. Department of Health & Human Services, August 2020. Accessed November 5, 2021. https://www.hhs.gov/hepatitis/learn-about-viral-hepatitis/hepatitis-b-basics/; 2Viral hepatitis surveillance United States.
4. Surveillance of Vaccination Coverage Among Adult Populations – United States, 2018. MMWR Surveill Summ. 2021 May 14;70(3);1-26.
5. O. Van Der Meeren et al. Hum Vaccin lmmunother. 2016 Aug; 12(8): 2197-2203.
6. O. Van Der Meeren et al. Hum Vaccin lmmunother. 2015;11(7):1726-9.
7. Francois-Xavier C. and Piroth L. Hum Vaccin Immunother. 2017; 13(6): 1304-1313.
8. Schillie et al. Diabetes Care. 2012 Dec; 35(12): 2690-2697.
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PRE.US.2.0068

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© 2024 VBI Vaccines Inc.
All Rights reserved.
PRE.US.2.0081

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ENROLLMENT2

Demographic and baseline characteristics were similar in both vaccine groups.

CONSTANT STUDY DESIGN3

STUDY OBJECTIVES

The primary objective was to demonstrate consistency of immune response as measured by geometric mean concentration of antibodies across three consecutively manufactured lots of PreHevbrio 10 μg. The secondary objective was to demonstrate non-inferiority of SPR (% of subjects achieving anti-HBs titers ≥10 mIU/mL) of PreHevbrio (pooled) compared to Engerix-B at Day 196.

ENROLLMENT3

Demographic and baseline characteristics were similar in both vaccine groups.

PROTECT STUDY DESIGN3

STUDY OBJECTIVES

The two co-primary objectives of comparing SPR (% of subjects achieving anti-HBs titers ≥10 mIU/mL) at 4 weeks after receiving the third dose of PreHevbrio or Engerix-B were non-inferiority in adults ≥18 years of age and superiority in adults ≥45 years of age for PreHevbrio 10 μg compared to Engerix-B 20 μg. Key secondary endpoints included SPRs for PreHevbrio at days 56 and 168 and for Engerix-B at day 196; local and systemic solicited adverse events; and unsolicited adverse events. Key exploratory endpoints included SPRs for both study groups at days 0, 28, 56, 168, and 336; geometric mean concentration of anti-HBs antibody titers; and the proportion of participants having anti-HBs titers ≥100 mIU/mL at days 28, 56, 168, 196, and 336.