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Only One Hepatitis B (HBV) Vaccine Helps Protect with The Power of 3

PreHevbrio expresses the Pre-S1, Pre-S2, and S antigens of HBV, and is the only 3-antigen HBV vaccine for adults.1,2,4

The Pre-S1 and Pre-S2 proteins serve important roles in the viral invasion of hepatocytes, and in viral infection, viral assembly, viral replication, and stimulation of immune responses in the body.5

Ready to get started with PreHevbrio? Need more information?

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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. Vesikari T, et al. Lancet Infect Dis. 2021; https://doi.org/10.1016/S1473-3099(20)30780-5.
2. Vesikari T, et al. JAMA. 2021;4(10):e2128652. doi:10.1001/jamanetworkopen.2021.28652.
3. Gerlich WH. Med Microbiol Immunol. 2015;204:39-55.
4. Liang TK. Hepatitis B: the virus and disease. Hepatology. 2009 May;49(5 Suppl): S13-21.
5. Wang, T. et al. Int J mol Med 42: 2689-2699, 2018. https://doi.org/10.3892/ijmm.2018.3831.
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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.