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Perinatal Hepatitis B Prevention Program TX Department of Health Services

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Perinatal Hepatitis B Prevention Program TX Department of Health Services

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    1. Perinatal Hepatitis B Prevention Program TX Department of Health Services Trudy Murphy, MD Prevention Branch Division of Viral Hepatitis NCHHSTP/CDC May 11, 2010

    2. 05/11/2010

    3. 05/11/2010 Rates of Symptomatic and Chronic HBV Infection by Age at Infection

    4. What is immunoprophylaxis ? A form of post-exposure prophylaxis (PEP) using hepatitis B vaccine and high titer hepatitis B immune globulin (HBIG) to prevent perinatal and postnatal transmission of hepatitis B virus infection Hepatitis B infection has a long incubation period* between exposure and disease; provides “window” for protecting against infection 05/11/2010

    5. 05/11/2010 Risk of Perinatal HBV Transmission Varies by Degree of Virus Replication among Pregnant Women with Chronic Infection HBsAg = Hepatitis B surface antigen, marker of acute or chronic infection (infectious) HBeAg =Hepatitis B e antigen, marker of high level active HBV replication (highly infectious)

    6. 05/11/2010 Overview ACIP recommendations for immunoprophylaxis to prevent perinatal hepatitis B infection Hepatitis B vaccines for infants Safety Efficacy with and without HBIG Efficacy in preterm infants Revaccinating non-responders

    7. 05/11/2010 Case Management to Prevent Perinatal HBV Infection-1 (Post-exposure Prophylaxis-PEP) Identify all HBsAg-positive women and case manage their infants Ensure their infants receive hepatitis B vaccine and HBIG = 12 hours of birth

    8. 05/11/2010 Case Management to Prevent Perinatal HBV Infection-2 (Post-exposure Prophylaxis-PEP) Complete the recommended primary series of hepatitis B vaccine BW > 2000 gm: 3-4 total doses of hepatitis B vaccine BW = 2000 gm (preterm infants): 4 total doses hepatitis B vaccine

    9. 05/11/2010 Case Management to Prevent Perinatal HBV Infections-3 (Post-exposure Prophylaxis-PEP) 1- 2 months after last dose, obtain “post-vaccination serology” (# 1) Wait at least 1 month after last dose: antigen from last dose of vaccine can give positive result (~18 days) Obtain serology as soon as possible but at least 9 months after last dose: some infants will be susceptible and will benefit from revaccination

    10. 05/11/2010 Case Management to Prevent Perinatal HBV Infections-4 (Post-exposure Prophylaxis-PEP) Post-vaccination serologic tests and their interpretation Anti-HBs =10 mIU/ml = immune HBsAg, if positive = HBV infected Educate to prevent HBV transmission and complete contact management for members of the household (screening, vaccination, referring for evaluation, care)

    11. 05/11/2010 Case Management to Prevent Perinatal HBV Infections-5 (Post-exposure Prophylaxis-PEP) Post-vaccination serology #1, Ctd If HBsAg-negative and anti-HBs <10 mIU/ml, the infant is still susceptible Revaccinate with 3 more doses hepatitis B vaccine (starting as soon as possible)

    12. 05/11/2010 Case Management to Prevent Perinatal HBV Infections- 6 (Post-exposure Prophylaxis-PEP) 1-2 months after last revaccination dose, check another post-vaccination serology (# 2) Immune - Anti-HBs =10 mIU/ml, Infected – HBsAg-positive, or Remains susceptible (non-responder) - anti-HBs <10 mIU/ml, HBsAg-negative

    13. 05/11/2010 Case Management to Prevent Perinatal HBV Infections- 7 (Post-exposure Prophylaxis-PEP) Complete education and contact management for members of the household (how to prevent transmission of HBV, screening, vaccination, referring for evaluation, care)

    14. 05/11/2010 Immunoprophylaxis to Prevent Perinatal HBV Infections-8 (Post-exposure Prophylaxis-PEP) Identify infants born to woman with unknown HBsAg status at delivery Ensure HBsAg test is ordered (ASAP) and case manage their infants

    15. 05/11/2010 Immunoprophylaxis to Prevent Perinatal HBV Infections-9 (Post-exposure Prophylaxis-PEP) Hepatitis B vaccine = 12 hours of birth, and BW = 2000 gm (preterm infants): HBIG = 12 hours unless mother’s HBsAg is now known to be negative BW >2000 gm: HBIG = 7 days if mother’s HBsAg test positive Case manage infant unless HBsAg-negative

    16. 05/11/2010 Immunoprophylaxis to Prevent Perinatal HBV Infections-8 (Post-exposure Prophylaxis-PEP) Infants born to woman with negative HBsAg at birthing hospital Encourage hospitals to adopt universal “birth dose” policy First dose hepatitis B vaccine before hospital discharge Safety net HBsAg-positive contacts, errors

    17. First Generation Hepatitis B Vaccines Plasma Derived Commercially available in 1982 Consisted of purified HBsAg (protein) from adults with chronic HBV infection; vaccine preparations treated to inactivate viruses Highly effective (>90%) Concerns about transmitting blood borne pathogens; discontinued 1990

    18. Second Generation Hepatitis B Vaccines Recombinant DNA Introduced 1986 Genetic sequences of HBsAg protein (S gene) “copied” into yeast cells, expressed HBsAg protein, purified to remove yeast cell products Adjuvant aluminum (hydroxide, phosphate) Thimerosal preservative-free since March 2000 05/11/2010

    19. Safety of Hepatitis B Vaccine >1 billion doses administered globally No increase in temperature, no increase in fever/sepsis “work-ups” after a birth dose Older infants, children local pain at injection site, 3% - 29% Low grade temperature (>37.7oC), 1% -6% Serious adverse reactions extremely rare 05/11/2010

    20. Hepatitis B Vaccine is Safe Does not cause Sudden Infant Death Syndrome (SIDS) Arthritis Guillain-Barré, brachial neuritis Demyelinating diseases (optic neuritis, multiple sclerosis, transverse myelitis, acute disseminated encephalomyelitis, etc) 05/11/2010 One of the most studied vaccines and one of the safest. One of the most studied vaccines and one of the safest.

    21. 2 Monovalent Recombinant Hepatitis B B Vaccines for Infants and Children MSD, Recombivax-HB®, 5 µg/0.5 ml dose (1986) GSK, Engerix-B®,10 µg/0.5 ml dose (1989) Both administered intramuscular route (IM) Approved for all doses in hepatitis B vaccine series, including a dose at birth Vaccines interchangeable in series 05/11/2010

    22. 2 Combination Vaccines with Hepatitis B, for Infants and Children GSK, Pediarix® (DTaP-IPV-HepB), HepB 10 µg/0.5 ml dose (2002) MSD, Comvax® (Hib-HepB), HepB 5 µg/0.5 ml dose (1996) Approved for ages 6 weeks and older (NOT for birth dose; poor responses to DTaP, Hib) Not interchangeable except with monovalent hepatitis B vaccines 05/11/2010

    23. Hepatitis B Vaccination Schedules for Infants: 3 or 4 Doses First 2 doses provide early protection Booster (last) dose given at a minimum age 24 weeks, adds long-term protection Delayed doses do not need to be repeated but…. Risk of infection continues during delay 05/11/2010

    24. Hepatitis B Vaccination 3 Dose Schedules for Infants ACIP recommended schedules (if mother HBsAg-negative) BW >2000 gm: age 0 (before hospital discharge), 1-2 & 6-18 months BW <2000 gm (preterm): at hospital discharge or age 1 month, 2-4 & 6-18 months Other schedules: age 0-2, 1-4, 6-18 months EPI (WHO) schedule: ages 6, 10, 14 weeks (birth dose adopted in some countries) 05/11/2010

    25. Hepatitis B Vaccination 4 Dose Schedules for Infants Safe: no increase in reactions with 4 doses Monovalent HepB vaccine at birth + 3 doses combination vaccine @ 2, 4, 6 months BW <2000 gm (preterm) born to HBsAg-positive or HBsAg-unknown status women; birth dose given (“not counted” for series) Chronological ages 0, 1, 2-3, 6-7 months 05/11/2010

    26. Background for Recommended Case Management to Prevent Perinatal Hepatitis B Infection Hepatitis B immune globulin (HBIG) Hepatitis B vaccine with and without HBIG Hepatitis B vaccine responses in preterm infants Protection for non-responders by revaccination 05/11/2010

    27. HBIG (alone) to Prevent Perinatal HBV Infection among Infants born to HBeAg-Positive Women, Taiwan, 1978-1982 05/11/2010

    28. 05/11/2010

    29. HBIG Prophylaxis for Infants Born to HBeAg-positive Women HBIG temporarily protected infants from hepatitis B virus infection More infected infants developed active response (immunity) to HBV infection than chronic infection Reduced chronic infections by ~50%-75% before age 15 months New infections continued 05/11/2010

    30. Hepatitis B Vaccine Trials Infants Born to HBsAg-Positive Women Vaccine efficacy defined as percent protected against chronic HBV infection in first year of life Historical controls for rates chronic infection, ~70%, 90% Rates of seroprotection (anti-HBsAg =10 mIU/ml) after 3 doses, measured at age 9-12 months; geometric mean titers anti-HBsAg

    31. Hepatitis B Vaccine Trials Infants Born to HBeAg-Positive Women Plasma and recombinant vaccines Dosages 2.5 - 20 µg HBsAg protein Regimens First dose <24 hours (3-5 days) of life Many schedules: 0, 1, 6 months; 0,1,2,12 months; 0, 1.5, 9 months, etc) With/without HBIG < 24 hours after birth

    32. Recombinant Hepatitis B Vaccine Efficacy Infants Born to HBeAg-Positive Women 05/11/2010

    33. Meta-analysis of 4 Trials (A, B, C, D) HBIG plus Hepatitis B Vaccine vs. Hepatitis B Vaccine Alone 05/11/2010

    34. Rates Chronic HBV Infection among Infants Born to HBeAg Positive Women 05/11/2010

    35. Vaccine Efficacy of Hepatitis B Vaccine among Highest Risk Infants (HBeAg-positive Mother) Vaccination series without HBIG prevents ~70% – 90% chronic HBV infections among infants at highest risk Vaccination series with HBIG (both administered = 12 hours of birth) prevents 85% - 95% chronic HBV infections among infants at highest risk 2%-10% (~5%) chronic infections not prevented 05/11/2010

    36. Seroprotection Anti-HBs =10 mIU/ml after vaccination correlates best with long-term protection, even as antibody wanes or no longer detected Vaccine “responders” protected 20+ years; studies in Asia and Alaska (HBV endemic) Breakthrough infections occur No symptomatic infection No chronic infection* 05/11/2010

    37. Seroprotection Rates and Geometric Mean Titers (GMT) of Anti-HBsAg among Infants Born to HBeAg-Positive Women 05/11/2010

    38. Seroprotection and Immunogenicity Immunogenicity and seroprotection rates improve with booster dose (# 3) Higher geometric mean titer (GMT) extends period of measureable antibody Seroprotection achieved among ~90+% infants after 3 doses hepatitis B vaccine ~5-10% infants non-responding; benefit from revaccination 05/11/2010

    39. Infant Seroprotection (SP) Rates after Revaccination with Hepatitis B Vaccine (HBsAg-Positive or -Negative Women) 05/11/2010

    40. Seroprotection Rates among Infant “Non-responders”after Revaccination Seroprotection rates achieved among 85%-95% of infant vaccine non-responders after revaccination Improved response likely tied to older age Use monovalent hepatitis B vaccine and routine dosage; effective, and avoids unnecessary doses of other components in combination vaccines 05/11/2010

    41. Hepatitis B Vaccine for Low Birth Weight (Preterm) Infants No special adverse reactions (monitor for apnea as needed) LBW infants (BW <2000 gm), especially ill preterm infants may have decreased immune response to hepatitis B vaccination starting at birth For low risk LBW (preterm) infants, ACIP recommends hepatitis B vaccine starting at age 1 month or hospital discharge 05/11/2010

    42. 05/11/2010

    43. Hepatitis B Vaccine for High Risk Low Birth Weight (Preterm) Infants LBW infants born to HBsAg-positive or HBsAg-unknown status women should receive vaccine and HBIG = 12 hours of birth Dose 1 (not counted); 2nd dose-1 given at age 1 month for infants born to HBsAg-positive women High risk LBW infants non-responders respond to revaccination (similar to normal BW infants) 05/11/2010

    44. Timing of Hepatitis B Vaccine Doses Makes a Difference HBIG >12 hr associated with higher rates perinatal HBV infection Dose 2 delayed to age =10 weeks, associated with higher rate perinatal hepatitis B infection Dose 3 (booster) at age =24 weeks improves long-term protection Dose 1 before hospital discharge associated with higher vaccination coverage for other vaccines 05/11/2010

    45. Immunoprophylaxis against Hepatitis B Virus Infection-Summary Hepatitis B vaccines are safe and very effective for infants and children Timely completion of case management with hepatitis B vaccine and HBIG prevents 90% - 95% chronic HBV infections acquired in the first year of life Revaccination effectively induces protection in 85% - 95% of non-responding infants 05/11/2010

    46. Immunoprophylaxis to Prevent Perinatal Hepatitis B Infection (PEP)-Conclusion Preventing chronic HBV infection prevents development of debilitating liver cirrhosis, hepatocellular cancer, and reduces the reservoir of persons transmitting hepatitis B infection Immunoprophylaxis for perinatal infections is life saving and cost-effective 05/11/2010

    47. 05/11/2010 Thank you Acknowledgements CDC/NCIRD/ISD Lisa Jacques-Carroll CDC/NCHHSTP/DVH Tanja Walker Geoffrey Beckett John Ward Perinatal Hepatitis B Coordinators

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