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1、会计学1PerinatalHepatitisBPreventionProgramTXDepartmentof围产期乙型肝炎预防围产期乙型肝炎预防(yfng)programtx部部第一页，共48页。05/11/2010Pathways for Transmission to Infants of Hepatitis B Virus Infection/?/PrenatalPerinatalPostnatal第1页/共47页第二页，共48页。05/11/2010Rates of Symptomatic and Chronic HBV Rates of Symptomatic and Chronic
2、 HBV Infection by Age at InfectionInfection by Age at InfectionAge at infectionAcute HBV(symptomatic)Chronic HBV 1 year5 years20 50%6 10%McMahon BJ J Infect Dis 1985;151:599Edmonds WJ Proc R Soc Lond B Biol Sc 1993; 253:197Hyams KC. Clin Infect Dis 1995;20:992第2页/共47页第三页，共48页。What is immunoprophylax
3、is ? n nA 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 infectionn nHepatitis B infection has a long incubation period* between exposure and disease; provides “w
4、indow” for protecting against infection05/11/2010*90 days range 60-150 days第3页/共47页第四页，共48页。05/11/2010Risk of Perinatal HBV Transmission Varies by Risk of Perinatal HBV Transmission Varies by Degree of Virus Replication amongDegree of Virus Replication amongPregnant Women with Chronic InfectionPregn
5、ant Women with Chronic Infectionn nHBsAg = Hepatitis B surface antigen, marker of acute or chronic infection (infectious)n nHBeAg =Hepatitis B e antigen, marker of high level active HBV replication (highly infectious)Serostatus of Mother % Infants InfectedHBsAgPositivePositiveHBeAgPositiveNegative70
6、% - 90% Highest risk 5% - 20% Lower risk第4页/共47页第五页，共48页。05/11/2010OverviewOverviewn nACIP recommendations for immunoprophylaxis to prevent perinatal hepatitis B infectionn nHepatitis B vaccines for infantsn nSafetySafetyn nEfficacy with and without HBIGEfficacy with and without HBIGn nEfficacy in p
7、reterm infantsEfficacy in preterm infantsn nRevaccinating non-respondersRevaccinating non-responders第5页/共47页第六页，共48页。05/11/2010Case Management toCase Management toPrevent Perinatal HBV Infection-1Prevent Perinatal HBV Infection-1(Post-exposure Prophylaxis-PEP) (Post-exposure Prophylaxis-PEP) Identif
8、y all HBsAg-positiveHBsAg-positive women women and case manage their infantsand case manage their infants Ensure their infants receive hepatitis B vaccine and HBIG HBIG 12 hours of birth12 hours of birthSituation A-Highest Risk Infants第6页/共47页第七页，共48页。 05/11/2010Case Management toCase Management toP
9、revent Perinatal HBV Infection-2Prevent Perinatal HBV Infection-2(Post-exposure Prophylaxis-PEP) (Post-exposure Prophylaxis-PEP) Complete the recommended primary Complete the recommended primary series of hepatitis B vaccineseries of hepatitis B vaccinen nBW 2000 gm: 3-4 total doses of BW 2000 gm: 3
10、-4 total doses of hepatitis B vaccinehepatitis B vaccinen nBW 2000 gm (preterm infants): BW 2000 gm (preterm infants): 4 total doses hepatitis B vaccine4 total doses hepatitis B vaccine第7页/共47页第八页，共48页。05/11/2010Case Management to Case Management to Prevent Perinatal HBV Infections-3Prevent Perinata
11、l HBV Infections-3(Post-exposure Prophylaxis-PEP) (Post-exposure Prophylaxis-PEP) 1- 2 months after last dose, obtain “post-1- 2 months after last dose, obtain “post-vaccination serology” (# 1)vaccination serology” (# 1)n nWait at least 1 month after last dose: Wait at least 1 month after last dose:
12、 antigen from last dose of vaccine can antigen from last dose of vaccine can give positive result (18 days)give positive result (18 days)n nObtain serology as soon as possible Obtain serology as soon as possible but at least 9 months after last dose: but at least 9 months after last dose: some infan
13、ts will be susceptible and some infants will be susceptible and will benefit from revaccinationwill benefit from revaccination第8页/共47页第九页，共48页。05/11/2010Case Management to Case Management to Prevent Perinatal HBV Infections-4Prevent Perinatal HBV Infections-4(Post-exposure Prophylaxis-PEP) (Post-exp
14、osure Prophylaxis-PEP) Post-vaccination serologic tests and their Post-vaccination serologic tests and their interpretationinterpretationn nAnti-HBsAnti-HBs 10 mIU/ml = immune 10 mIU/ml = immunen nHBsAgHBsAg, if positive = HBV infected , if positive = HBV infected n nEducate to prevent HBV transmiss
15、ion and Educate to prevent HBV transmission and complete contact management for members of complete contact management for members of the household (screening, vaccination, the household (screening, vaccination, referring for evaluation, care)referring for evaluation, care)第9页/共47页第十页，共48页。05/11/201
16、0Case Management to Case Management to Prevent Perinatal HBV Infections-5Prevent Perinatal HBV Infections-5(Post-exposure Prophylaxis-PEP) (Post-exposure Prophylaxis-PEP) Post-vaccination serology #1, CtdPost-vaccination serology #1, Ctdn nIf If HBsAg-negative HBsAg-negative andand anti-HBs anti-HBs
17、 10 10 mIU/ml, the infant is still susceptiblemIU/ml, the infant is still susceptible Revaccinate with 3 more doses Revaccinate with 3 more doses hepatitis B vaccine (starting as soon hepatitis B vaccine (starting as soon as possible)as possible)第10页/共47页第十一页，共48页。05/11/2010Case Management to Preven
18、t Perinatal HBV Infections- 6(Post-exposure Prophylaxis-PEP) (Post-exposure Prophylaxis-PEP) 1-2 months after last 1-2 months after last revaccinationrevaccination dose, check another post-vaccination serology (# 2) n nImmune - Immune - Anti-HBsAnti-HBs 10 mIU/ml, 10 mIU/ml, n nInfected Infected HBs
19、Ag-HBsAg-positive, orpositive, orn nRemains susceptible (non-responder) - anti-Remains susceptible (non-responder) - anti-HBs 10 mIU/ml, HBsAg-negativeHBs 2000 gm: HBIG 7 days if mothers BW 2000 gm: HBIG 7 days if mothers HBsAg test positiveHBsAg test positiven nCase manage infant unless HBsAg-negat
20、ive第14页/共47页第十五页，共48页。05/11/2010 Immunoprophylaxis to Immunoprophylaxis to Prevent Perinatal HBV Infections-8Prevent Perinatal HBV Infections-8(Post-exposure Prophylaxis-PEP) (Post-exposure Prophylaxis-PEP) Infants born to woman with negative HBsAg at birthing hospital Encourage hospitals to adopt u
21、niversal “birth dose” policyn nFirst dose hepatitis B vaccine before First dose hepatitis B vaccine before hospital dischargehospital dischargen nSafety net HBsAg-positive contacts, errorsSafety net HBsAg-positive contacts, errorsSituation C- Most Infants第15页/共47页第十六页，共48页。First Generation Hepatitis
22、 B Vaccines First Generation Hepatitis B Vaccines Plasma Derived Plasma Derived n nCommercially available in 1982n nConsisted of purified HBsAg (protein) from adults with chronic HBV infection; vaccine preparations treated to inactivate virusesn nHighly effective (90%)n nConcerns about transmitting
23、blood borne pathogens; discontinued 1990 05/11/2010第16页/共47页第十七页，共48页。Second Generation Hepatitis B Vaccines Second Generation Hepatitis B Vaccines Recombinant DNA Recombinant DNA n nIntroduced 1986n nGenetic sequences of HBsAg protein (S gene) “copied” into yeast cells, expressed HBsAg protein, pur
24、ified to remove yeast cell products n nAdjuvant aluminum (hydroxide, phosphate)n nThimerosal preservative-free since March 2000 05/11/2010第17页/共47页第十八页，共48页。Safety of Hepatitis B VaccineSafety of Hepatitis B Vaccinen n1 billion doses administered globallyn nNo increase in temperature, no increase in
25、 fever/sepsis “work-ups” after a birth dosen nOlder infants, children n nlocal pain at injection site, 3% - 29% local pain at injection site, 3% - 29% nno oC), 1% -6%C), 1% -6%n nSerious adverse reactions extremely rare05/11/2010Multiple vaccine trials among infants.& children 第18页/共47页第十九页，共48页。Hep
26、atitis B Vaccine is Safen nDoes not cause n nSudden Infant Death Syndrome (SIDS)Sudden Infant Death Syndrome (SIDS)n nArthritisArthritisn nGuillain-Barr, brachial neuritisGuillain-Barr, brachial neuritisn nDemyelinating diseases (optic neuritis, Demyelinating diseases (optic neuritis, multiple scler
27、osis, transverse myelitis, multiple sclerosis, transverse myelitis, acute disseminated encephalomyelitis, etc) acute disseminated encephalomyelitis, etc) 05/11/2010Institute of Medicine Report 2002第19页/共47页第二十页，共48页。2 Monovalent Recombinant Hepatitis B B Vaccines for Infants and Children n nMSD, Rec
28、ombivax-HB, 5 g/0.5 ml dose (1986)n nGSK, Engerix-B,10 g/0.5 ml dose (1989)n nBoth administered intramuscular route (IM)n nApproved for all doses in hepatitis B vaccine series, including a dose at birthn nVaccines interchangeable in series 05/11/2010第20页/共47页第二十一页，共48页。2 Combination Vaccines with 2
29、Combination Vaccines with Hepatitis B, for Infants and ChildrenHepatitis B, for Infants and Childrenn nGSK, Pediarix (DTaP-IPV-HepB), HepB 10 g/0.5 ml dose (2002)n nMSD, Comvax (Hib-HepB), HepB 5 g/0.5 ml dose (1996)n nApproved for ages 6 weeks and older (NOT for birth dose; poor responses to DTaP,
30、Hib)n nNot interchangeable except with monovalent hepatitis B vaccines05/11/2010第21页/共47页第二十二页，共48页。Hepatitis B Vaccination SchedulesHepatitis B Vaccination Schedulesfor Infants: 3 or 4 Dosesfor Infants: 3 or 4 Dosesn nFirst 2 doses provide early protection n nBooster (last) dose given at a minimum
31、age 24 weeks, adds long-term protection n nDelayed doses do not need to be repeated but.n nRisk of infection continues during delayRisk of infection continues during delay05/11/2010第22页/共47页第二十三页，共48页。Hepatitis B Vaccination3 Dose Schedules for Infantsn nACIP recommended schedules (if mother HBsAg-n
32、egative)n nBW 2000 gm: age 0 (before hospital BW 2000 gm: age 0 (before hospital discharge), 1-2 & 6-18 monthsdischarge), 1-2 & 6-18 monthsn nBW 2000 gm (preterm): at hospital BW 2000 gm (preterm): at hospital discharge or age 1 month, 2-4 & 6-18 discharge or age 1 month, 2-4 & 6-18 monthsmonthsn nO
33、ther schedules: age 0-2, 1-4, 6-18 months n nEPI (WHO) schedule: ages 6, 10, 14 weeks (birth dose adopted in some countries) 05/11/2010第23页/共47页第二十四页，共48页。Hepatitis B VaccinationHepatitis B Vaccination4 Dose Schedules for Infants 4 Dose Schedules for Infants n nSafe: no increase in reactions with 4
34、dosesn nMonovalent HepB vaccine at birth + 3 doses combination vaccine 2, 4, 6 monthsn nBW 2000 gm (preterm) born to HBsAg-positive or HBsAg-unknown status women; birth dose given (“not counted” for series) n nChronological ages 0, Chronological ages 0, 1, 2-3, 6-71, 2-3, 6-7 months months05/11/2010
35、MMWR 2005;54 (RR-16)第24页/共47页第二十五页，共48页。Background for Recommended Background for Recommended Case Management to Prevent Perinatal Case Management to Prevent Perinatal Hepatitis B InfectionHepatitis B Infectionn nHepatitis B immune globulin (HBIG)n nHepatitis B vaccine with and without HBIG n nHepat
36、itis B vaccine responses in preterm infantsn nProtection for non-responders by revaccination05/11/2010第25页/共47页第二十六页，共48页。HBIG (alone) to Prevent Perinatal HBV HBIG (alone) to Prevent Perinatal HBV Infection among Infants born to HBeAg-Infection among Infants born to HBeAg-Positive Women, Taiwan, 19
37、78-1982Positive Women, Taiwan, 1978-1982Type of ProphylaxisSchedule Age (Months)No. InfantsChronic HBV Age 15 Mo.Placebo (Saline) 1.0 mlBirth, 3 & 6 6192%HBIG * 1.0 ml x 1Birth5754%HBIG 0.5 ml x 3Birth, 3 & 6 6726%05/11/2010Beasley RP. Dev Biol Stand 1982;54:363-375*HBIG= 180 mIU/ml Birth dose admin
38、istered in delivery room, 95% 1hr第26页/共47页第二十七页，共48页。05/11/2010Infants (%) with Chronic Hepatitis B VirusInfection by Treatment Group and AgeBeasley RP. Dev Biol Stand 1982;54:363-375第27页/共47页第二十八页，共48页。HBIG Prophylaxis for Infants Born to HBIG Prophylaxis for Infants Born to HBeAg-positive WomenHBe
39、Ag-positive Womenn nHBIG temporarily protected infants from hepatitis B virus infectionn nMore infected infants developed active response (immunity) to HBV infection than chronic infectionn nReduced chronic infections by 50%-75% before age 15 monthsn n New infections continued05/11/2010Beasley RP. D
40、ev Biol Stand 1982;54:363-375第28页/共47页第二十九页，共48页。Hepatitis B Vaccine Trials Hepatitis B Vaccine Trials Infants Born to HBsAg-Positive WomenInfants Born to HBsAg-Positive Womenn nVaccine efficacy defined as percent protected against chronic HBV infection in first year of lifen nHistorical controls fo
41、r rates chronic infection, Historical controls for rates chronic infection, 70%, 90%70%, 90%n nRates of seroprotection (anti-HBsAg 10 mIU/ml) after 3 doses, measured at age 9-12 months; geometric mean titers anti-HBsAg Reviewed in: Mast E. Vaccine, Eds. Orenstein W, Plotkin S, 2004, 200905/11/2010第2
42、9页/共47页第三十页，共48页。Hepatitis B Vaccine Trials Hepatitis B Vaccine Trials Infants Born to HBeAg-Positive WomenInfants Born to HBeAg-Positive Womenn nPlasma and recombinant vaccinesn nDosages 2.5 - 20 g HBsAg protein n nRegimensn nFirst dose 24 hours (3-5 days) of lifeFirst dose 24 hours (3-5 days) of l
43、ifen nMany schedules: 0, 1, 6 months; 0,1,2,12 Many schedules: 0, 1, 6 months; 0,1,2,12 months; 0, 1.5, 9 months, etc)months; 0, 1.5, 9 months, etc)n nWith/without HBIG 24 hours after birthWith/without HBIG 94*41377* GSK 10 ug6455100 92*180229 05/11/2010*Measured at age 9 months第36页/共47页第三十七页，共48页。S
44、eroprotection and Immunogenicityn nImmunogenicity and seroprotection rates improve with booster dose (# 3)n nHigher geometric mean titer (GMT) extends period of measureable antibodyn nSeroprotection achieved among 90+% infants after 3 doses hepatitis B vaccinen n5-10% infants non-responding; benefit
45、 from revaccination05/11/2010第37页/共47页第三十八页，共48页。Infant Seroprotection (SP) Rates after Infant Seroprotection (SP) Rates after Revaccination with Hepatitis B VaccineRevaccination with Hepatitis B Vaccine(HBsAg-Positive or -Negative Women)(HBsAg-Positive or -Negative Women)CountryVaccine1o SeriesNo.
46、InfantsSP Rate1o SeriesNo. Infants# Doses% 10 mIU/ml anti-HBsAgIran-2005 -21380%34294%Netherlands1992Plasma -10 DNA- 20705-93 - 4100%Italy-1998GSK-10180598%38295%Iran-2008DNA 2.5,5,10138096%48183%Iran-1997GSK-10117693%221 - 291%05/11/2010Roushan MRH. Eur J Elin Microbiol Infect Dis 2005; del Canho R
47、. Vaccine 1992; Belloni C. Vaccine 1998; Jafarzadeh A. Vaccine 2008; Shokri F. Med MicrobiolImmunol 1997. 第38页/共47页第三十九页，共48页。Seroprotection Rates among Infant “Non-Seroprotection Rates among Infant “Non-responders”after Revaccinationresponders”after Revaccinationn nSeroprotection rates achieved amo
48、ng 85%-95% of infant vaccine non-responders after revaccinationn nImproved response likely tied to older agen nUse monovalent hepatitis B vaccine and routine dosage; effective, and avoids unnecessary doses of other components in combination vaccines05/11/2010第39页/共47页第四十页，共48页。Hepatitis B Vaccine fo
49、r Low Birth Weight (Preterm) Infantsn nNo special adverse reactions (monitor for apnea as needed)n nLBW infants (BW 12 hr associated with higher rates perinatal HBV infection n nDose 2 delayed to age 10 weeks, associated with higher rate perinatal hepatitis B infection n nDose 3 (booster) at age 24
50、weeks improves long-term protectionn nDose 1 before hospital discharge associated with higher vaccination coverage for other vaccines 05/11/2010Fischer G et al. PIDJ 2009; Yusuf HR et al. JAMA 2000第43页/共47页第四十四页，共48页。Immunoprophylaxis against Immunoprophylaxis against Hepatitis B Virus Infection-Sum
51、maryHepatitis B Virus Infection-Summaryn nHepatitis B vaccines are safe and very effective for infants and childrenn nTimely completion of case management with hepatitis B vaccine and HBIG prevents 90% - 95% chronic HBV infections acquired in the first year of lifen nRevaccination effectively induce
52、s protection in 85% - 95% of non-responding infantsn n 05/11/2010第44页/共47页第四十五页，共48页。Immunoprophylaxis to Prevent Perinatal Immunoprophylaxis to Prevent Perinatal Hepatitis B Infection (PEP)-ConclusionHepatitis B Infection (PEP)-Conclusionn nPreventing chronic HBV infection prevents development of d
53、ebilitating liver cirrhosis, hepatocellular cancer, and reduces the reservoir of persons transmitting hepatitis B infection n nImmunoprophylaxis for perinatal infections is life saving and cost-effective05/11/2010第45页/共47页第四十六页，共48页。05/11/2010Thank youAcknowledgementsAcknowledgementsn nCDC/NCIRD/ISDCDC/NCIRD/ISDn nLisa Jacques-Carrolln nCDC/NCHHSTP/DVHCDC/NCHHSTP/DVHn nTanja Walkern nGeoffrey Beckettn nJohn Wardn nPerinatal Hepatitis B Coordinators第46页/共47页第四十七页，共48页。内容(nirng)总结会计学。第1页/共47页。第2页/共47页。5-10% infants non-responding。DNA 2.5,5,10。Coordinators。第46页/共47页第四十八页，共48页。
