Hepatitis B and Hepatitis B Vaccine

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• Hepatitis B and Hepatitis B Vaccine

Epidemiology and Prevention of Vaccine-Preventable
Diseases National Immunization Program Centers
for Disease Control and Prevention
Revised January 2007
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NOTICEContent and order of the slides in this
file may differ from those presented on the
broadcast and webcast
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Hepatitis B Virus

• Small DNA virus
• Humans are only known host
• Several subtypes that do not affect virulence or
  infectivity
• May retain infectivity for more than 7 days at
  room temperature

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Hepatitis B Virus
HBsAg
HBcAg
HBeAg
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Hepatitis B Virus Infection

• More than 350 million chronically infected
  worldwide
• Established cause of chronic hepatitis and
  cirrhosis
• Cause of up to 80 of hepatocellular carcinomas
• 600,000 deaths worldwide in 2002

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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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• Risk of Chronic HBV Carriage by Age of Infection

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Hepatitis B Epidemiology

• Reservoir Human
• Transmission Bloodborne
  Asymptomatic cases transmit
• Communicability 1-2 months before and after
  onset of symptoms

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• Hepatitis BUnited States, 1978-2006

Year
2006 provisional total
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HepatitisUnited States, 2005

• Highest incidence among adults 25 to 45 years of
  age
• 79 associated with high risk sexual activity or
  injection drug use
• 5 associated with other known exposures (e.g.,
  household and occupational exposures)
• 16 deny a specific risk factor for infection

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Hepatitis B Vaccine

• Composition Recombinant HBsAg
• Efficacy 95 (Range, 80-100)
• Duration ofImmunity gt15 years
• Schedule 3 Doses

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Hepatitis B Vaccine Formulations

• 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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• Recommended Dose of Hepatitis B Vaccine

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 lt11 years of
age Adolescents 11-19 years Adults gt20 years
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Hepatitis B VaccineLong-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

Routine booster doses are NOT routinely
recommended for any group
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Hepatitis B Vaccine Indications

• Infants beginning at birth
• Adolescents through 18 years of age
• Adults at increased risk of HBV infection

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Hepatitis B Vaccine 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 Hepatitis 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

• Preterm infants lt2,000 grams have a decreased
  response to vaccine administered before 1 month
  of age
• Delay first dose until chronologic age 1 month if
  mother documented to be HBsAg negative
• Postexposure management must be started
  immediately if the mother is HBsAg positive, or
  if the mothers HBsAg status is not known

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COMVAX

• Hepatitis B-Hib combination
• Use when either antigen is indicated
• Cannot administer to infants younger than 6 weeks
  of age
• May be used in infants whose mothers are HBsAg
  positive or status is unknown

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Pediarix

• DTaP IPV Hep B combination
• Approved for 3 doses at 2, 4 and 6 months
• Minimum age for first dose is 6 weeks
• May be used in infants whose mothers are HBsAg
  positive or status is unknown

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Pediarix

• 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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Twinrix

• Combination hepatitis B (adult dose) and
  hepatitis A vaccine (pediatric dose)
• 3-dose series at 0, 1, 6-12 months
• Approved for persons 18 years of age and older
• Can be used interchangeably with monovalent
  hepatitis B and hepatitis A vaccine

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Hepatitis B Vaccine Adolescent and Adult Schedule
Minimum Interval - - - 4 weeks 8 weeks
Usual Interval --- 1 month 5 months

• Dose
• Primary 1
• Primary 2
• Primary 3

third dose must be separated from first dose by
at least 16 weeks
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Alternative Adolescent Vaccination Schedule

• Two 1.0 mL (10 mcg) doses of Recombivax HB
  separated by 4-6 months
• Approved only for adolescents 11 through 15
  years of age
• Only applies to Merck hepatitis B vaccine

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Postvaccination Serologic Testing

• Not routinely recommended following vaccination
  of infants, children, adolescents, or most adults
• Recommended for
• hemodialysis patients
• immunocompromised persons
• Sex partners of persons with chronic HBV
  infection
• certain healthcare personnel

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Postvaccination Serologic Testing

• Healthcare personnel who have contact with
  patients or blood and are at ongoing risk for
  injuries with sharp instruments or needles should
  be tested for antibody after vaccination

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Management of Nonresponse to Hepatitis B Vaccine

• 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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Hepatitis B VaccineAdverse Reactions
Infants and Children 3-9 0-20 0.4-6 rare
Adults 13-29 11-17 1 rare

• Pain at injection site
• Mild systemic complaints(fatigue, headache)
• Temperature 99.9F (37.7C)
• Severe systemic reactions

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Hepatitis B VaccineContraindications and
Precautions

• Severe allergic reaction to a vaccine component
  or following a prior dose
• Moderate or severe acute illness

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Prevention of Perinatal Hepatitis B Virus
Infection

• 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 anti-HBs and HBsAg at 9 to 18 months of
  age

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National Immunization ProgramContact Information

• Telephone 800.CDC.INFO
• Email nipinfo_at_cdc.gov
• Website www.cdc.gov/nip