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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
  • 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.
  • Transcript

    • 1. Vaccines D-r Mitova MU-Sofia
    • 2. Hepatitis B and Hepatitis B vaccine
      • 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
    • 3. 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
    • 4. 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
    • 5. HBsAg HBcAg HBeAg Hepatitis B Virus
    • 6. 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
    • 7. Symptoms HBeAg anti-HBe Total anti-HBc IgM anti-HBc anti-HBs HBsAg 0 4 8 12 16 20 24 28 32 36 52 100 Acute Hepatitis B Virus Infection with Recovery Typical Serologic Course Weeks after Exposure Titre
    • 8. Hepatitis B Complications
      • Fulminant hepatitis
      • Hospitalization
      • Cirrhosis
      • Hepatocellular carcinoma
      • Death
    • 9. Chronic Hepatitis B Virus Infection
      • Chronic viremia
      • Responsible for most mortality
      • Overall risk 10%
      • Higher risk with early infection
    • 10.
      • Risk of Chronic HBV Carriage by Age of Infection
    • 11. Hepatitis B Epidemiology
      • Reservoir Human. Endemic
      • Transmission Bloodborne
      • Subclinical cases transmit
      • Communicability 1-2 months before and after onset of symptoms
      • Chronic carriers
    • 12. 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
    • 13. 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
    • 14.  
    • 15. Age of Infection of Acute and Chronic Hepatitis B Virus Infection Acute infection Chronic infection CDC Sentinel Sites.
    • 16.
      • Risk Factors for Hepatitis B
      CDC Sentinel Sites. 2001 data.
    • 17. 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
    • 18. Strategy to Eliminate Hepatitis B Virus Transmission
      • 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
    • 19. 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
    • 20. Hepatitis B Vaccine
      • Composition Recombinant HBsAg
      • Efficacy 95% (Range, 80%-100%)
      • Duration of Immunity >15 years
      • Schedule 3 Doses
      • Booster doses not routinely recommended
    • 21. 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)
    • 22. 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
    • 23.
      • Recommended Dose of Hepatitis B Vaccine
      Infants and children <11 years of age Adolescents 11-19 years Adults > 20 years (16) 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)
    • 24. 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
    • 25.
      • Hepatitis B Vaccine
      Routine booster doses are NOT routinely recommended for any group
    • 26.
      • Hepatitis B Vaccine Recommendations
      Year 1981 1991 1995 Recommendation Persons at high risk All infants Adolescents
    • 27. Indications for Hepatitis B Vaccine
      • Infants
      • Adolescents 11-12 years of age
      • Selected adults
    • 28.
      • Dose
      • Primary 1
      • Primary 2
      • Primary 3
      Usual Age 0 months 1 months 6 months Minimum Interval - - - 4 weeks 8 weeks* Hepatitis B Vaccine Routine Infant Schedule *and at least 16 weeks after the first dose
    • 29. 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
    • 30. 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
    • 31. 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
    • 32. Hepatitis B Vaccine Adolescent Vaccination
      • Routine vaccination recommended through age 18 years
      • Integrate into routine adolescent immunization visit
      • Flexible schedules
    • 33.
      • 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
    • 34. Adult Hepatitis B Vaccine Candidates
      • Men who have sex with men
      • Heterosexual with multiple partners
      • Prostitutes
      • Injection drug users
      • Inmates of long-term correctional facilities
      • Persons receiving dialysis
      • Healthcare workers
    • 35. 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
    • 36. 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
    • 37. 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
    • 38. Postvaccination Serologic Testing
      • Healthcare workers who have contact with patients or blood should be tested for antibody after vaccination.
    • 39. 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
    • 40. 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
    • 41. 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
    • 42. Twinrix
      • Combination hepatitis B (adult dose) and hepatitis A vaccine (pediatric dose)
      • Schedule: 0, 1, 6-12 months
      • Approved for persons > 18 years
    • 43. 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
    • 44. Hepatitis B Vaccine Contraindications and Precautions
      • Severe allergic reaction to a vaccine component or following a prior dose
      • Moderate or severe acute illness
    • 45. Tuberculosis
      • HIV/AIDS, TB and malaria kill 6 million people every year; nearly 2 million deaths are caused by TB
      • 2 billion people — one third of the world's population — are infected with TB bacilli, the microbes that cause TB. 1 in 10 people infected with TB bacilli will become sick with active TB in their lifetime; people with HIV are at a much greater risk
      • Almost 9 million new TB cases occurred in 2004 — 80% of them in 22 countries
    • 46. Persons at Risk for Developing TB Disease
      • Those who have been recently infected
      • Those with clinical conditions that increase their risk of progressing from LTBI to TB disease
      Persons at high risk for developing TB disease fall into 2 categories
    • 47.  
    • 48.
      • Bacillus of Calmette and Guérin (BCG) is a vaccine against tuberculosis that is prepared from a strain of the attenuated (weakened) live bovine tuberculosis bacillus, Mycobacterium bovis, that has lost its virulence in humans by being specially cultured in an artificial medium for years. The bacilli have retained enough strong antigenicity to become a somewhat effective vaccine for the prevention of human tuberculosis. At best, the BCG vaccine is 80% effective in preventing tuberculosis for a duration of 15 years.
    • 49. BCG Contraindications
      • Contraindicated in persons with impaired immune response from
      • HIV infection
      • Congenital immunodeficiency
      • Leukemia
      • Lymphoma
      • Generalized malignancy
      • Receiving high-dose steroid therapy
      • Receiving alkylating agents
      • Receiving antimetabolites
      • Receiving radiation therapy
    • 50.  
    • 51. After having the injection, it is normal to develop a red lump over the injection site.
    • 52. It is not necessary to cover the site with a bandage unless it oozes
    • 53. This may increase in size for a few weeks before settling down into a scab.
    • 54.
      • BCG vaccine may cause side effects .
      • swollen lymph nodes
      • small red areas at the site of injection. (These usually appear 10-14 days after injection and slowly decrease in size. They should disappear after about 6 months.)
      • fever
      • blood in the urine
      • frequent or painful urination
      • upset stomach
      • vomiting
    • 55. Testing for M. tuberculosis Mantoux tuberculin skin test (TST) Skin test that produces delayed-type hypersensitivity reaction in persons with M. tuberculosis infection
    • 56. Administering the TST
      • Inject 0.1 ml of 5 TU PPD tuberculin solution intradermally on volar surface of lower arm
      • Produce a wheal 6 to 10 mm in diameter
    • 57. Reading the TST (1)
      • Measure reaction in 48 to 72 hours
      • Measure induration, not erythema
      • Record reaction in millimeters, not “negative” or “positive”
      • Ensure trained health care professional measures and interprets the TST
    • 58. TST Interpretation (1)
      • 5-mm induration is interpreted as positive in
      • HIV-infected persons
      • Close contacts to an infectious TB case
      • Persons with chest radiographs consistent with prior untreated TB
    • 59. TST Interpretation (2)
      • 5-mm induration is interpreted as positive in (cont.)
      • Organ transplant recipients
      • Other immunosuppressed patients (e.g., those taking the equivalent of >15 mg/d of prednisone for 1 month or those taking TNF- α antagonists )
    • 60. TST Interpretation (3)
      • 10-mm induration is interpreted as positive in
      • Recent immigrants
      • Injection drug users
      • Residents or employees of congregate settings
      • Mycobacteriology laboratory personnel
    • 61. TST Interpretation (4)
      • 10-mm induration is interpreted as positive in (cont.)
      • Persons with clinical conditions that place them at high risk
      • Children < 4 years; infants, children, and adolescents exposed to adults at high-risk
    • 62. TST Interpretation (5)
      • Persons with no known risk factors for TB.*
      *Although skin testing programs should be conducted only among high-risk groups, certain individuals may require TST for employment or school attendance. Diagnosis and treatment of LTBI should always be tied to risk assessment. 15-mm induration is interpreted as positive in ____________________________________________________
    • 63. Factors That May Cause False-Positive TST Reactions
      • Nontuberculous mycobacteria
        • Reactions caused by nontuberculous mycobacteria are usually  10 mm of induration
      • BCG vaccination
        • Reactivity in BCG vaccine recipients generally wanes over time; positive TST result is likely due to TB infection if risk factors are present
    • 64. Factors That May Cause False-Negative TST Reactions (1)
      • Anergy
        • Inability to react to a TST because of a weakened immune system
        • Usefulness of anergy testing in TST-negative persons who are HIV infected has not been demonstrated
    • 65. Factors That May Cause False-Negative TST Reactions (2)
      • Recent TB infection
        • Defined as 2 to 10 weeks after exposure
      • Very young age
        • Newborns
    • 66. Factors That May Cause False-Negative TST Reactions (3)
      • Live-virus vaccination
        • For example, measles or smallpox
        • Can temporarily suppress TST reactivity
      • Overwhelming TB disease
      • Poor TST administration technique
        • For example, TST injection too shallow or too deep, or wheal is too small
    • 67. DTaP Vaccination Pertussis
      • Highly contagious respiratory infection caused by Bordetella pertussis
      • Outbreaks first described in 16th century
      • Bordetella pertussis isolated in 1906
      • Estimated 285,000 deaths worldwide in 2001
    • 68. Whole-Cell Pertussis Vaccine
      • Developed in mid-1930s and combined as DTP in mid-1940s
      • 70%-90% efficacy after 3 doses
      • Protection for 5-10 years
      • Local adverse reactions common
    • 69. Acellular Pertussis Vaccine (DTaP)
      • Purified &quot;subunit&quot; vaccines
      • Intended to reduce adverse reactions
      • Licensed for fourth and fifth doses in 1991
      • Licensed for full series in 1996
    • 70. Diphtheria
      • Greek diphtheria (leather hide)
      • Recognized by Hippocrates in 5th century B.C.
      • Epidemics described in 6th century
      • C. diphtheriae described by Klebs in 1883
      • Toxoid developed in 1920s
    • 71. Corynebacterium diphtheriae
      • Aerobic gram-positive bacillus
      • Toxin production occurs only when C. diphtheriae infected by virus (phage) carrying tox gene
      • If isolated, must be distinguished from normal diphtheroid
    • 72. Tetanus
      • First described by Hippocrates
      • Etiology discovered in 1884 by Carle and Rattone
      • Passive immunity used for treatment and prophylaxis during World War I
      • Tetanus toxoid first widely used during World War II
    • 73. Clostridium tetani
      • Anaerobic gram-positive, spore-forming bacteria
      • Spores found in soil, dust, animal feces; may persist for months to years
      • Multiple toxins produced with growth of bacteria
      • Tetanospasmin estimated human lethal dose = 2.5 ng/kg
    • 74. Tetanus Clinical Features
      • Incubation period; 8 days (range, 3-21 days)
      • Three clinical forms: Local (not common), cephalic (rare), generalized (most common)
      • Generalized tetanus: descending symptoms of trismus (lockjaw), difficulty swallowing, muscle rigidity, spasms
      • Spasms continue for 3-4 weeks; complete recovery may take months
    • 75. Neonatal Tetanus
      • Generalized tetanus in newborn infant
      • Infant born without protective passive immunity
      • High fatality rate without therapy
      • Estimated >215,000 deaths worldwide in 1998
    • 76. Tetanus Complications
      • Laryngospasm
      • Fractures
      • Hypertension
      • Nosocomial infections
      • Pulmonary embolism
      • Aspiration
      • Death
    • 77. Tetanus Epidemiology
      • Reservoir Soil and intestine of animals and humans
      • Transmission Contaminated wounds Tissue injury
      • Temporal pattern Peak in summer or wet season
      • Communicability Not contagious
    • 78. Tetanus Toxoid
      • Formalin-inactivated tetanus toxin
      • Schedule Three or four doses + booster Booster every 10 years
      • Efficacy Approximately 100%
      • Duration Approximately 10 years
      • Should be administered with diphtheria toxoid as DTaP, DT, or Td
    • 79. Routine DTaP Primary Vaccination Schedule (Pentaxim in Bulgaria) Dose Primary 1 Primary 2 Primary 3 Primary 4 Age 2 months 3 months 4 months 16-24 months Interval --- 4 wks 4 wks 6 mos
    • 80.
      • 6 years ( DTaP polio) Tetraxim
      • 12 years of age (Td)
      • 17 years of age (Td)
      • Every 10 years thereafter (Td)
      Booster Doses
    • 81. Routine Td Schedule Unvaccinated Persons > 7 Years of Age Booster dose every 10 years Dose Primary 1 Primary 2 Primary 3 Interval --- 4 wks 6-12 mos
    • 82. Diphtheria and Tetanus Toxoids Adverse Reactions
      • Local reactions (erythema, induration)
      • Exaggerated local reactions (Arthus-type)
      • Fever and systemic symptoms not common
      • Severe systemic reactions rare
    • 83. Diphtheria and Tetanus Toxoids Contraindications and Precautions
      • Severe allergic reaction to vaccine component or following prior dose
      • Moderate or severe acute illness
    • 84. DTaP Adverse Reactions
      • Local reactions
      • Low grade fever
      • More severe adverse reactions not common
      • Local reactions more common following 4 th and 5 th doses
    • 85. Adverse Reactions Following the 4th and 5th DTaP Dose
      • Local adverse reactions and fever increased with 4th and 5th doses of DTaP
      • Reports of swelling of entire limb
      • Extensive swelling after 4th dose NOT a contraindication to 5th dose
    • 86. DTaP Contraindications
      • Serious allergic reaction to vaccine component or following prior dose
      • Encephalopathy occurring within 7 days after vaccination not due to another identifiable cause
    • 87. DTaP Precautions
      • Moderate or severe acute illness
      • Temperature > 40 C or higher within 48 hours with no other identifiable cause
      • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
      • Persistent, inconsolable crying lasting > 3 hours, occurring within 48 hours
      • Convulsions with or without fever occurring within 3 days
      *may consider use in outbreaks
    • 88. Pertussis Vaccine Use in Children with Underlying Neurologic Disorders Underlying Condition Prior seizure Suspected neurologic disorder Neurologic event between doses Stable/resolved neurologic condition Recommendation Delay and assess* Delay and assess* Delay and assess* Vaccinate * vaccinate after treatment initiated and condition stabilized
    • 89. Tetanus Wound Management * Yes, if >10 years since last dose ** Yes, if >5 years since last dose Vaccination History Unknown or <3 doses 3+ doses Td TIG Yes No No* No Td TIG Yes Yes No** No Clean, minor wounds All other wounds