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Hepatitis B and Hepatitis B Vaccine. Epidemiology and Prevention of Vaccine-Preventable Diseases National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention. Revised May 2009. Note to presenters:

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Hepatitis B and Hepatitis B Vaccine

Epidemiology and Prevention of Vaccine-Preventable Diseases

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Revised May 2009


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Note to presenters:

Images of vaccine-preventable diseases are available from the Immunization Action Coalition website at http://www.vaccineinformation.org/photos/index.asp


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Hepatitis B

  • Epidemic jaundice described by Hippocrates in 5th century BCE

  • Jaundice reported among recipients of human serum and yellow fever vaccines in 1930s and 1940s

  • Australia antigen described in 1965

  • Serologic tests developed in 1970s


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Hepatitis B Virus

  • Hepadnaviridae family (DNA)

  • Numerous antigenic components

  • Humans are only known host

  • May retain infectivity for more than 7 days at room temperature


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Hepatitis B Virus Infection

  • More than 350 million chronically infected worldwide

  • Established cause of chronic hepatitis and cirrhosis

  • Human carcinogen—cause of up to 80% of hepatocellular carcinomas

  • More than 600,000 deaths worldwide in 2002


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Hepatitis B Virus

HBsAg

HBcAg

HBeAg


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Hepatitis B Clinical Features

  • Incubation period 60-150 days (average 90 days)

  • Nonspecific prodrome of malaise, fever, headache, myalgia

  • Illness not specific for hepatitis B

  • At least 50% of infections asymptomatic


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Hepatitis B Complications

  • Fulminant hepatitis

  • Hospitalization

  • Cirrhosis

  • Hepatocellular carcinoma

  • Death


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Chronic Hepatitis B Virus Infection

  • Chronic viremia

  • Responsible for most mortality

  • Overall risk 5%

  • Higher risk with early infection



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Hepatitis B Epidemiology

  • Reservoir Human

  • Transmission Bloodborne Asymptomatic infections transmit

  • Communicability 1-2 months before and after onset of symptoms Chronic infection


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Hepatitis B Perinatal Transmission*

  • If mother positive for HBsAg and HBeAg

    • 70%-90% of infants infected

    • 90% of infected infants become chronically infected

  • If positive for HBsAg only

    • 5%-20% of infants infected

    • 90% of infected infants become chronically infected

*in the absence of postexposure prophylaxis


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Global Patterns of Chronic HBV Infection

  • High (>8%): 45% of global population

    • lifetime risk of infection >60%

    • early childhood infections common

  • Intermediate (2%-7%): 43% of global population

    • lifetime risk of infection 20%-60%

    • infections occur in all age groups

  • Low (<2%): 12% of global population

    • lifetime risk of infection <20%

    • most infections occur in adult risk groups


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Decline among

men who have sex with men

Decline among

IV drug users

Hepatitis B vaccine licensed

Hepatitis B—United States, 1978-2007

Year


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HBV Disease Burden in the United States

  • Prevaccine era

    • estimated 300,000 persons infected annually, including 24,000 infants and children

  • 2005

    • estimated 51,000 infections


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Age of Infection of Acute and Chronic Hepatitis B Virus Infection

Acute infection

Chronic infection

CDC Sentinel Sites. 1989 data.


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Risk Factors for Hepatitis B Infection

MMWR 2006;55(RR-16):6-7


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Hepatitis B Virus Infection by Duration of High-Risk Behavior

IV drug user

HCWs

Homosexual men

Heterosexual

100

80

60

Percent infected

40

20

0

0

3

6

9

12

15

Years at Risk


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Strategy to Eliminate Hepatitis B Virus Transmission—United States

  • Prevent perinatal HBV transmission

  • Routine vaccination of all infants

  • Vaccination of children in high-risk groups

  • Vaccination of adolescents

  • Vaccination of adults in high-risk groups


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Hepatitis B Vaccine Transmission—United States

1965 Discovery of Australian antigen

1973 Successful HBV infection of chimpanzees

1981 Licensure of plasma-derived vaccine

1986 Licensure of recombinant vaccine

1991 Universal infant vaccination

1996 Universal adolescent vaccination


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Hepatitis B Vaccine Transmission—United States

  • Composition Recombinant HBsAg

  • Efficacy 95% (Range, 80%-100%)

  • Duration ofImmunity 20 years or more

  • Schedule 3 Doses

  • Booster doses not routinely recommended


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Hepatitis B Vaccine Formulations Transmission—United States

  • Recombivax HB (Merck) - 5 mcg/0.5 mL (pediatric) - 10 mcg/1 mL (adult) - 40 mcg/1 mL (dialysis)

  • Engerix-B (GSK) - 10 mcg/0.5 mL (pediatric) - 20 mcg/1 mL (adult)


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Protection* by Age Group and Dose Transmission—United States

* Anti-HBs antibody titer of 10 mIU/mL or higher

** Preterm infants less than 2 kg have been shown to respond to vaccination less often

*** Factors that may lower vaccine response rates are age older than 40 years, male gender, smoking, obesity, and immune deficiency


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Recommended Dose of Hepatitis B Vaccine Transmission—United States

Recombivax HB

Dose (mcg)

0.5 mL (5)

0.5 mL (5)

1.0 mL (10)

Engerix-B

Dose (mcg)

0.5 mL (10)

0.5 mL (10)

1.0 mL (20)

Infants and children

<11 years of age

Adolescents 11-19 years

Adults >20 years


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Hepatitis B Vaccine Transmission—United StatesLong-term Efficacy

  • Immunologic memory established following vaccination

  • Exposure to HBV results in anamnestic anti-HBs response

  • Chronic infection rarely documented among vaccine responders


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Hepatitis B Vaccine Transmission—United States

Routine booster doses are NOT routinely recommended for any group


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Hepatitis B Vaccine Transmission—United States

Routine Infant Schedule

Dose+

Primary 1

Primary 2

Primary 3

Usual Age

Birth

1- 2 months

6-18 months*

Minimum

Interval

- - -

4 weeks

8 weeks**

* infants who mothers are HBsAg+ or whose HBsAg status is

unknown should receive the third dose at 6 months of age

** at least 16 weeks after the first dose

+an additional dose at 4 months is acceptable if the clinician prefers to use a combination vaccine that contains hepatitis B vaccine


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Third Dose of Transmission—United StatesHepatitis B Vaccine

  • Minimum of 8 weeks after second dose, and

  • At least 16 weeks after first dose, and

  • For infants, at least 24 weeks of age


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Preterm Infants Transmission—United States

  • Birth dose and HBIG if mother HBsAg positive (within 12 hours of birth)

  • Preterm infants who weigh less than 2,000 grams have a decreased response to vaccine administered before 1 month of age

  • Delay first dose until chronologic age 1 month if mother HBsAg negative


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COMVAX Transmission—United States

  • Hepatitis B-Hib combination

  • Use when either antigen is indicated

  • Cannot use at younger than 6 weeks of age

  • May be used in infants whose mother is HBsAg positive or status is unknown


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Pediarix Transmission—United States

  • DTaP – Hep B – IPV combination

  • Approved for 3 doses at 2, 4 and 6 months

  • Not approved for booster doses

  • Licensed for children 6 weeks to 7 years of age


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Pediarix Transmission—United States

  • May be used interchangeably with other pertussis-containing vaccines if necessary

  • Can be given at 2, 4, and 6 months to infants who received a birth dose of hepatitis B vaccine (total of 4 doses)

  • May be used in infants whose mothers are HBsAg positive or status unknown


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Combination Vaccine Rule Transmission—United States

  • The minimum intervals between doses of a combination vaccine are dictated by the single antigen with the longest minimum intervals

  • For Pediarix the minimum intervals are determined by the hepatitis B component


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Hepatitis B Vaccine Transmission—United StatesAdolescent Vaccination

  • Routine vaccination recommended through age 18 years

  • Integrate into routine adolescent immunization visit

  • Flexible schedules


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Hepatitis B Vaccine Transmission—United States

Adolescent and Adult Schedule

Dose

Primary 1

Primary 2

Primary 3

Usual

Interval

---

1 month

5 months

Minimum

Interval

- - -

4 weeks

8 weeks*

*third dose must be separated from

first dose by at least 16 weeks


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Alternative Adolescent Vaccination Schedule Transmission—United States

  • Two 1.0 mL (10 mcg) doses of Recombivax HB separated by 4-6 months

  • Approved only for adolescents 11-15 years of age

  • Only applies to Merck hepatitis B vaccine


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Adults at Risk for HBV Infection Transmission—United States

  • Sexual exposure

    • sex partners of HBsAg-positive persons

    • sexually active persons not in a long-term, mutually monogamous relationship*

    • persons seeking evaluation or treatment for a sexually transmitted disease

    • men who have sex with men

*persons with more than one sex partner

during the previous 6 months


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Adults at Risk for HBV Infection Transmission—United States

  • Percutaneous or mucosal exposure to blood

    • current or recent IDU

    • household contacts of HBsAg-positive persons

    • residents and staff of facilities for developmentally disabled persons

    • healthcare and public safety workers with risk for exposure to blood or blood-contaminated body fluids

    • persons with end-stage renal disease


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Adults at Risk for HBV Infection Transmission—United States

  • Others groups

    • international travelers to regions with high or intermediate levels (HBsAg prevalence of 2% or higher) of endemic HBV infection

    • persons with HIV infection


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Twinrix Transmission—United States

  • Combination hepatitis A vaccine (pediatric dose) and hepatitis B (adult dose)

  • Schedules

    • 0, 1, 6 months, or

    • 0, 7, 21- 30 days and a booster dose at 12 months

  • Approved for persons 18 years of age and older


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New Twinrix Schedule Transmission—United States

  • Doses at 0, 7, 21- 30 days and a booster dose at 12 months

  • ACIP has no recommendation regarding the new schedule

  • The first 3 doses of the new schedule provide equivalent protection to:

    • the first dose in the standard single-antigen adult hepatitis A vaccine series

    • the first 2 doses in the standard adult hepatitis B vaccine series


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New Twinrix Schedule Transmission—United States

  • Seroconversion is nearly 100% after either 3 doses of Twinrix on the new schedule or a single dose of single-antigen adult hepatitis A vaccine

  • No increased benefit of the new schedule for the hepatitis B component compared to administration of 2 hepatitis B vaccine doses 1 to 2 months apart


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Prevaccination Serologic Testing Transmission—United States

  • Not indicated before routine vaccination of infants or children

  • Recommended for

    • all persons born in Africa, Asia, the Pacific Islands, and other regions with HBsAg prevalence of 8% or higher

    • household, sex, and needle-sharing contacts of HBsAg-positive persons

    • HIV-infected persons

  • Consider for

    • Groups with high risk of HBV infection (MSM, IDU, incarcerated persons)


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Postvaccination Serologic Testing Transmission—United States

  • Not routinely recommended following vaccination of infants, children, adolescents, or most adults

  • Recommended for:

    • Infants born to HBsAg+ women

    • Hemodialysis patients

    • Immunodeficient persons

    • Sex partners of persons with chronic HBV infection

    • Certain healthcare personnel


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Healthcare personnel who have contact with patients or blood should be tested for anti-HBs (antibody to hepatitis B surface antigen) 1 to 2 months after completion of the 3-dose series

Postvaccination Serologic Testing


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Management of Nonresponse to Hepatitis B Vaccine blood should be tested for anti-HBs (antibody to hepatitis B surface antigen) 1 to 2 months after completion of the 3-dose series

  • Complete a second series of three doses

  • Should be given on the usual schedule of 0, 1 and 6 months

  • Retest 1-2 months after completing the second series


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Persistent Nonresponse to Hepatitis B Vaccine blood should be tested for anti-HBs (antibody to hepatitis B surface antigen) 1 to 2 months after completion of the 3-dose series

  • Less than 5% of vaccinees do not develop anti-HBs after 6 valid doses

  • May be nonresponder or "hyporesponder"

  • Check HBsAg status

  • If exposed, treat as nonresponder with postexposure prophylaxis


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Prevention of Perinatal Hepatitis B Virus Infection blood should be tested for anti-HBs (antibody to hepatitis B surface antigen) 1 to 2 months after completion of the 3-dose series

  • Begin treatment within 12 hours of birth

  • Hepatitis B vaccine (first dose) and HBIG at different sites

  • Complete vaccination series at 6 months of age

  • Test for response after completion of at least 3 doses of the HepB series at 9 through 18 months of age (generally at the next well-child visit)


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Hepatitis B Vaccine blood should be tested for anti-HBs (antibody to hepatitis B surface antigen) 1 to 2 months after completion of the 3-dose seriesAdverse Reactions

Pain at injection site

Mild systemic complaints(fatigue, headache)

Temperature ≤99.9°F (37.7°C)

Severe systemic reactions

Infants and Children

3%-9%

0%-20%

0.4%-6%

rare

Adults

13%-29%

11%-17%

1%

rare


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Hepatitis B Vaccine blood should be tested for anti-HBs (antibody to hepatitis B surface antigen) 1 to 2 months after completion of the 3-dose seriesContraindications and Precautions

  • Severe allergic reaction to a vaccine component or following a prior dose

  • Moderate or severe acute illness


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CDC Vaccines and Immunization blood should be tested for anti-HBs (antibody to hepatitis B surface antigen) 1 to 2 months after completion of the 3-dose seriesContact Information

  • Telephone 800.CDC.INFO

  • Email [email protected]

  • Website www.cdc.gov/vaccines


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