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  • Although HBV has numerous antigens, only the presence of HBsAg indicates active infection. Antibody to HBsAg, from either disease or vaccine, indicates immunity.
  • 35
  • The reduction of reported cases in the late 1990s is not likely due to vaccine. An estimated 100k infections continue to occur annually, primarily in young adults.
  • This graphic shows the distribution of risk factors in 2001. Persons with multiple sexual contacts, men who have sex with men, and sexual contact with a person known to have HBV infection account for 54 percent of cases with a known risk factor. Injection drug use accounts for 20 percent of cases. About 3 percent of cases are in people who have household contact with a person with acute or chronic hepatitis B. Fifteen years ago, health care workers accounted for 2 percent of HBV infections- 2 or 3 thousand new infections each year. Since that time, the rate of infection among health care workers has declined by 95 percent, and is now lower than the rate for the general population. Hepatitis B vaccine has made occupational HBV infection a thing of the past.
  • 5 5 5
  • In December 2002, the US Food and Drug Administration approved a new combination vaccine- Pediarix- which is manufactured by Glaxo Smith Kline. This vaccine contains DTaP, inactivated polio and hepatitis B vaccines. The DTaP component is Infanrix, and the hepatitis B component is Engerix-B, which were previously licensed in the U.S. Pediarix is approved for the first three doses of the DTAP and IPV series, which are usually given at about 2, 4, and 6 months of age. However, Pediarix is approved for use through 6 years of age. The minimum age for the first dose of Pediarix is 6 weeks. So it can’t be used for the birth dose of the hepatitis B series.
  • Interchangeable Can be used after a birth dose of heaptitis B – total of 4 doses O.K. Pediarix may be used in infants born to women who are hepatitis B surface antigen positive or whose hepatitis B status is unknown. Like COMVAX, Pediarix is not approved for this use. But at it’s February 2003 meeting, ACIP voted to allow the use of Pediarix to complete the hepatitis B series in these infants. But remember that the minimum age for Pediarix is 6 weeks, so it must NOT be used for the birth or one month dose of the hepatitis B series. Another important fact to remember about Pediarix is that the minimum intervals between doses are dictated by the single antigen with the longest minimum intervals. Therefore, Pediarix minimum intervals are determined by the hepatitis B component. As for hepatitis B vaccine, the minimum interval between the first two doses of Pediarix is 4 weeks. The third dose must be administered at least 8 weeks after the second dose, and should follow the first dose by at least 16 weeks. The third dose should not be given before 6 months of age to be counted as a valid third dose of hepatitis B vaccine.

Hep B8p Hep B8p Presentation Transcript

    • Hepatitis B and Hepatitis B Vaccine
    Epidemiology and Prevention of Vaccine-Preventable Diseases National Immunization Program Centers for Disease Control and Prevention Revised December 2004
  • Note to presenters: Images of vaccine-preventable diseases are available from the Immunization Action Coalition website at http://www.vaccineinformation.org/photos/index.asp
  • 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
    • Australian antigen described in 1965
    • Serologic tests developed in 1970s
  • Hepatitis B Virus
    • Hepadnaviridae family (DNA)
    • Numerous antigenic components
    • Humans are only known host
    • May retain infectivity for at least 1 month at room temperature
  • Hepatitis B Virus Infection
    • > 200 million carriers worldwide
    • Established cause of chronic hepatitis and cirrhosis
    • Human carcinogen—cause of up to 80% of hepatocellular carcinomas
  • HBsAg HBcAg HBeAg Hepatitis B Virus
  • Hepatitis B Clinical Features
    • Incubation period 6 weeks to 6 months (average 120 days)
    • Nonspecific prodrome of fever, malaise, headache, myalgia
    • Illness not specific for hepatitis B
    • At least 50% of infections asymptomatic
  • Hepatitis B Complications
    • Fulminant hepatitis
    • Hospitalization
    • Cirrhosis
    • Hepatocellular carcinoma
    • Death
  • Chronic Hepatitis B Virus Infection
    • Chronic viremia
    • Responsible for most mortality
    • Overall risk 10%
    • Higher risk with early infection
    • Risk of Chronic HBV Carriage by Age of Infection
  • Hepatitis B Epidemiology
    • Reservoir Human. Endemic
    • Transmission Bloodborne
    • Subclinical cases transmit
    • Communicability 1-2 months before and after onset of symptoms
    • Chronic carriers
  • Hepatitis B Perinatal Transmission*
    • If mother positive for HBsAg and HBeAg
      • 70%-90% of infants infected
      • 90% of infected infants become chronic carriers
    • If positive for HBsAg only
      • 20% of infants infected
      • 90% of infected infants become chronic carriers
    *in the absence of postexposure prophylaxis
  • 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
    • Hepatitis B—United States, 1978-2002
    Hepatitis B vaccine licensed Decline among homosexual men Decline among IV drug users
  • HBV Disease Burden in the United States*
    • Total infections 78,000/yr
    • Current carriers >1 million
    • New carriers >5,000/yr
    • Death 5,000/yr
    *2001 estimates
  • Age of Infection of Acute and Chronic Hepatitis B Virus Infection Acute infection Chronic infection CDC Sentinel Sites. 1989 data.
    • Risk Factors for Hepatitis B
    CDC Sentinel Sites. 2001 data.
  • Hepatitis B Virus Infection by Duration of High-Risk Behavior 0 3 6 9 12 15 Years at Risk 0 20 40 60 80 100 Percent infected IV drug user Homosexual men HCWs Heterosexual
  • 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
  • Hepatitis B Vaccine 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
  • Hepatitis B Vaccine
    • Composition Recombinant HBsAg
    • Efficacy 95% (Range, 80%-100%)
    • Duration of Immunity >15 years
    • Schedule 3 Doses
    • Booster doses not routinely recommended
  • Hepatitis B Vaccine Formulations
    • Recombivax HB (Merck) - 5.0 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)
  • Protection* by Age Group and Dose * 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 >40 years, male gender, smoking, obesity, and immune deficiency 90%-95% 98%-100% 3 75%-80% 80%-95% 2 20%-30% 16%-40% 1 Teens and Adults*** Infants** Dose
    • Recommended Dose of Hepatitis B Vaccine
    Infants and children <11 years of age Adolescents 11-19 years Adults > 20 years 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)
  • Hepatitis B Vaccine Long-term Efficacy
    • Immunologic memory established following vaccination
    • Exposure to HBV results in anamnestic anti-HBs response
    • Chronic infection rarely documented among vaccine responders
    • Hepatitis B Vaccine
    Routine booster doses are NOT routinely recommended for any group
    • Hepatitis B Vaccine Recommendations
    Year 1981 1991 1995 Recommendation Persons at high risk All infants Adolescents
  • Indications for Hepatitis B Vaccine
    • Infants
    • Adolescents 11-12 years of age
    • Selected adults
    • Dose
    • Primary 1
    • Primary 2
    • Primary 3
    Usual Age 0-2 months 1- 4 months 6-18 months Minimum Interval - - - 4 weeks 8 weeks* Hepatitis B Vaccine Routine Infant Schedule *and at least 16 weeks after the first dose
  • 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
  • Very Low Birthweight Infants
    • Infants <2000 grams respond poorly to vaccine
    • Delay first dose until chronological age 1 month if mother HBsAg negative
    • Birth dose and HBIG if mother HBsAg positive
  • COMVAX
    • Hepatitis B-Hib combination
    • Use when either antigen is indicated
    • Cannot use <6 weeks of age
    • May be used in infants whose mothers are HBsAg positive or status is not known
  • Pediarix
    • 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
  • Pediarix
    • May be used interchangeably with other pertussis-containing vaccines if necessary
    • Can be given at 2, 4, and 6 months in 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 not known
  • Hepatitis B Vaccine Adolescent Vaccination
    • Routine vaccination recommended through age 18 years
    • Integrate into routine adolescent immunization visit
    • Flexible schedules
    • Dose
    • Primary 1
    • Primary 2
    • Primary 3
    Minimum Interval - - - 4 weeks 8 weeks* Usual Interval --- 1 month 5 months Hepatitis B Vaccine Adolescent and Adult Schedule *third dose must be separated from first dose by at least 16 weeks
  • Alternative Adolescent Vaccination Schedule
    • Two 10 mcg doses of Recombivax HB separated by 4-6 months
    • May only be used for adolescents 11-15 years of age
    • Only applies to Merck hepatitis B vaccine
  • Adult Hepatitis B Vaccine Candidates
    • Men who have sex with men
    • Heterosexual with multiple partners
    • Persons diagnosed with an STD
    • Prostitutes
    • Injection drug users
    • Inmates of long-term correctional facilities
    • Persons receiving dialysis
    • Healthcare workers
  • Adult Hepatitis B Vaccine Candidates
    • Staff of institutions for developmentally disabled
    • Alaskan Natives, Pacific Islanders
    • Immigrants/refugees*
    • Adoptees, orphans, unaccompanied minors*
    • Household members and sexual partners of HBV carriers
    • Extended travel to areas of high endemicity
    • Recipients of certain blood products
    *from countries of high or intermediate HBV endemnicity
  • Prevaccination Serologic Testing
    • Not indicated before routine vaccination of infants or children
    • May be considered when vaccinating adolescents in groups with high rates of HBV infection
      • Alaskan Natives
      • Pacific Islanders
      • Children of immigrants from endemic countries
      • Family members of HBV carriers
  • Postvaccination Serologic Testing
    • Not routinely recommended following vaccination of infants, children, adolescents, or most adults
    • Recommended for:
      • Infants born to HBsAg+ women
      • Dialysis patients
      • Immunodeficient persons
      • Certain healthcare workers
  • Postvaccination Serologic Testing
    • Healthcare workers who have contact with patients or blood should be tested for antibody after vaccination.
  • 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
  • Persistent Nonresponse to Hepatitis B Vaccine
    • <5% of vaccinees do not develop anti-HBsAg after 6 valid doses
    • May be nonresponder or &quot;hyporesponder&quot;
    • Check HBsAg status
    • If exposed, treat as nonresponder with postexposure prophylaxis
  • 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 response at 9-15 months of age
  • Twinrix
    • Combination hepatitis B (adult dose) and hepatitis A vaccine (pediatric dose)
    • Schedule: 0, 1, 6-12 months
    • Approved for persons > 18 years
  • Hepatitis B Vaccine Adverse Reactions
    • Pain at injection site
    • Mild systemic complaints (fatigue, headache)
    • Temperature >99.9 ° F (37.7 ° C)
    • Severe systemic reactions
    Adults 13%-29% 11%-17% 1% rare Infants and Children 3%-9% 0%-20% 0.4%-6% rare
  • Hepatitis B Vaccine Contraindications and Precautions
    • Severe allergic reaction to a vaccine component or following a prior dose
    • Moderate or severe acute illness
  • National Immunization Program
    • Hotline 800.232.2522
    • Email [email_address]
    • Website www.cdc.gov/nip