UA-114300590-5

THREE-DOSE VACCINES MAY LEAVE INMATES AND CORRECTIONS HEALTHCARE WORKERS UNPROTECTED

~82% of inmates do not complete the hepatitis B series1

 

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IN CLINICAL STUDIES, MANY FAILED TO ACHIEVE PROTECTIVE IMMUNITY EVEN  AFTER COMPLETING ALL 3 DOSES OF A TRADITIONAL HEPATITIS B VACCINE

~20% TO 30%

of people failed to achieve protective
immunity and remain unprotected 2

~35% of people with diabetes failed to achieve protective immunity and remain unprotected 2,3

IT TAKES 6 MONTHS TO COMPLETE A TRADITIONAL

3-DOSE HEPATITIS B VACCINE SERIES 4

DOC timeline chart

 

THERE IS NO PARTIAL PROTECTION FROM HEPATITIS B

 

TWO DOSES OF HEPLISAV-B PROVIDED EARLIER AND HIGHER LEVELS OF PROTECTIVE IMMUNITY THAN 3 DOSES OF ENGERIX-B IN PATIENTS AGED 18-55 YEARS 2

 

95% of Those Who Received HEPLISAV-B Were Protected After Just 2 Doses in 1 Month 2,5*

 

trial 1 chart

 

*Compared to 81.3% who received 3 doses of Engerix-B. 2

†Protective immunity defined as antibody concentration ≥10 mIU/mL. 6

 

• 13.7% difference (95% CI, 10.4 to 17.5) in protective immunity between patient groups at primary endpoint 2
• The primary analysis compared the rate of protective immunity at week 12 for HEPLISAV-B with that at week 28 for Engerix-B 2
• Statistical significance was met; however, statistical significance was not prespecified in trial 1 5
• Noninferiority was met because the lower bound of the 95% confidence interval of the difference in SPRs was greater than -10% 2

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INDICATION
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.


IMPORTANT SAFETY INFORMATION
Do not administer HEPLISAV-B 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 HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to 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 time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).
Engerix-B is a registered trademark of the GSK group of companies.


Please see accompanying full Prescribing Information.

Engerix-B is a registered trademark of the GSK group of companies.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

References: 1. Bridges CB, Watson TL, Nelson NP, et al. Challenges with hepatitis B
vaccination of high risk adults – A pilot program. Vaccine. 2019;37(35):5111-5120.
2. HEPLISAV-B [package insert]. Berkeley, CA: Dynavax Technologies Corporation; 2018
3. Jackson S, Letino J, Kopp J, et al. Immunogenicity of a two-dose investigational
hepatitis B vaccine. HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared
with a licensed hepatitis B vaccine in adults. Vaccine. 2018; 36(5):668-674. 4. Mast EE,
Weinbaum CM, Fiore AE, et al. A comprehensive immunization strategy to eliminate
transmission of hepatitis B virus infection in the United States: recommendations of
the Advisory Committee on Immunization Practices (ACIP) Part II: immunization of
adults. MMWR Recomm Rep. 2006;55(16):1-33. 5. Dynavax Technologies Corporation. FDA Advisory Committee Briefing Document: HEPLISAV-B™ (Hepatitis B Vaccine [Recombinant], Adjuvanted). Presented at: Meeting of the Vaccines and Related Biological Products Advisory Committee; July 28, 2017; Silver Spring, MD. 6. Centers for Disease Control and Prevention. Hepatitis B. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:149-174. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf. Accessed
October 16, 2017.

US-20-02-00049

INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION

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

IMPORTANT SAFETY INFORMATION

Do not administer HEPLISAV-B 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 HEPLISAV-B, including yeast.

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

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to 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 time of vaccine administration.

The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).

Please see full Prescribing Information.