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Study Results:

Immunogenicity

PROTECT—Phase 3 Clinical Trial to Evaluate Immunogenicity and Safety1

PROTECT Study Design

PreHevbrio was evaluated in a double-blind, randomized, two-arm, safety and immunogenicity study of adults (n=1,607), including those with well-controlled chronic conditions across 28 sites in Europe, the U.S., and Canada.1

More Adults Achieved Seroprotection with PreHevbrio in PROTECT1

PreHevbrio elicited non-inferior seroprotection rates (SPR) in adults age 18+, and statistically significantly higher SPR in adults age 45+, compared to Engerix-B

Seroprotection Rates at Day 196

* Seroprotection was defined as anti-HBs titres ≥10 mlU/mL; SPR was defined as the percentage of participants attaining seroprotection.

Seroprotection rates across age groups1

Seroprotection Rates at Day 196

Concentration of Anti-HBs antibody titers across age groups4

Antibody Titers at Day 196

CONSTANT—Phase 3 clinical trial to evaluate lot-to-lot consistency1

CONSTANT Study Design

PreHevbrio was evaluated in a double-blind, randomized, four-arm, lot-to-lot consistency study of adults age 18 to 45 (n=2,838) across 35 sites in Europe, the U.S., and Canada.2

Seroprotection Rates in Adults Age 18-451,2

PreHevbrio achieved non-inferior SPR in adults age 18-45

Seroprotection Rates at Day 196

* Seroprotection was defined as anti-HBs titers ≥10 mIU/mL; SPR was defined as the percentage of participants attaining seroprotection.

Concentration of Anti-HBs Antibody Titers2

Antibody Titers at Day 196

* Seroprotection was defined as anti-HBs titers ≥10 mIU/mL; SPR was defined as the percentage of participants attaining seroprotection.

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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. PREHEVBRIO Prescribing Information. Cambridge, MA. VBI Vaccines Inc.
2. Vesikari T, et al. JAMA Network Open. 2021;4(10):e2128652. doi:10.1001/jamanetworkopen.2021.28652.
3. Vesikari T, et al. Lancet Infect Dis. 2021; https://doi.org/10.1016/ S1473-3099(20)30780-5.
4. Langley J, et al. Poster Presented at AASLD. The Liver Meeting 2020. November 13-16, 2020. A0742.
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PRE.US.2.0068

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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.