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Implications for Pandemic Influenza Preparedness

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Implications for Pandemic Influenza Preparedness ImpactImpact ofof ConjugateConjugate PneumococcalPneumococcal VaccineVaccine onon PneumococcalPneumococcal Pneumonia:Pneumonia: ImplicationsImplications forfor PandemicPandemic InfluenzaInfluenza PreparednessPreparedness KeithKeith P.P. KlugmanKlugman DepartmentDepartment ofof GlobalGlobal Health,Health, RollinsRollins SchoolSchool ofof PublicPublic HealthHealth andand DivisionDivision ofof InfectiousInfectious Diseases,Diseases, SchoolSchool ofof MedicineMedicine EmoryEmory University,University, Atlanta,Atlanta, USAUSA AcuteAcute respiratoryrespiratory infectionsinfections –– thethe leadingleading infectiousinfectious causecause ofof deathdeath 4.0 3.5 3.0 Over age five Under age five 2.5 * HIV-positive people 2.0 who have died with TB have been 1.5 included among AIDS deaths Millions of deaths 1.0 0.5 0 Acute AIDS* Diarrhoeal TB Malaria Measles respiratory diseases infections Estimates for adults 2002; under 5’s 2000-2003; World Health Report 2004/52 CommunityCommunity AcquiredAcquired PneumoniaPneumonia frequencyfrequency byby ageage // 10001000 40 35 30 25 20 15 10 5 0 << 55 55 -- 14 14 1515 -- 29 29 3030 -- 44 44 4545 -- 59 59 6060 -- 74 74 >> 7474 AgeAge (years)(years) Jokinen et al. Am J Epidemiol 1993;137:977-988 Jokinen et al. Am J Epidemiol 1993;137:977-988 3 BacterialBacterial EtiologyEtiology ofof CommunityCommunity-- AcquiredAcquired PneumoniaPneumonia Atypical pathogens: Legionella spp S. pneumoniae Chlamydia spp Mycoplasma spp 22% 34% 6% S. aureus 15% 15% Other 8% H. influenzae and M. catarrhalis Aerobic gram-negative rods Cunha BA. Chest. 2004;125:1913-1919; American Thoracic Society. Am J Respir Crit Care Med. 2001;163:1730-1754. 4 EtiologicalEtiological RoleRole ofof BacteriaBacteria inin PneumoniaPneumonia OurOur toolstools toto definedefine aa bacterialbacterial etiologyetiology inin pneumoniapneumonia areare insensitiveinsensitive BloodBlood cultureculture identifiesidentifies lessless thanthan 10%10% ofof presumedpresumed bacterialbacterial pneumonia.pneumonia. LungLung puncture,puncture, BALBAL andand protectedprotected specimenspecimen brushbrush techniquestechniques areare rarelyrarely donedone andand areare overlyoverly invasive.invasive. SerologicalSerological teststests havehave beenbeen confoundedconfounded byby lacklack ofof specificityspecificity UrineUrine antigenantigen isis promisingpromising inin adultsadults butbut isis confoundedconfounded byby NPNP carriagecarriage inin childrenchildren PCRPCR hashas notnot toto datedate realizedrealized aa sensitivitysensitivity greatergreater thanthan thatthat ofof cultureculture 5 VaccineVaccine asas aa ProbeProbe toto DefineDefine thethe AetiologyAetiology ofof PneumoniaPneumonia WhileWhile thethe adultadult 2323 valentvalent vaccinevaccine hashas notnot beenbeen shownshown inin randomizedrandomized trialstrials ofof thethe elderlyelderly toto preventprevent clinicalclinical oror XX--rayray confirmedconfirmed pneumonia,pneumonia, recentrecent datadata suggestsuggest thatthat conjugateconjugate vaccinesvaccines maymay dodo soso inin children.children. HaemophilusHaemophilus typetype BB conjugateconjugate vaccinevaccine hashas beenbeen shownshown toto impactimpact onon pneumoniapneumonia TheseThese vaccinesvaccines maymay thusthus toto usedused asas probesprobes toto definedefine thethe rolerole ofof bacteriabacteria inin thethe etiologyetiology ofof pneumonia.pneumonia. 6 ALVEOLARALVEOLAR CONSOLIDATIONCONSOLIDATION 7 EfficacyEfficacy ofof HaemophilusHaemophilus influenzaeinfluenzae PRPPRP –– TT ConjugateConjugate VaccineVaccine inin thethe PreventionPrevention ofof PneumoniaPneumonia 100%100% efficacyefficacy againstagainst bacteremicbacteremic pneumoniapneumonia (95%(95% CICI 5555 –– 100)100) 25.2%25.2% reductionreduction inin lobarlobar consolidationconsolidation withwith effusioneffusion (95%(95% CICI 0.20.2 –– 44.1)44.1) 21.1%21.1% reductionreduction inin allall radiologicallyradiologically provenproven pneumoniapneumonia (95%(95% CICI 4.64.6 –– 34.9)34.9) Mulholland et al, Lancet 1997; 349: 1191 – 97. 8 Prevention of Pneumonia in Children 4-23 months by PRP-T, Chile C,E C,E,ESR C,E,BB C,E,ESR,BB C, consolidation or E, effusion, or ESR>40mm, or BB, bronchial breathing Levine et al, PIDJ, 1999;18:1060-1064 9 EffectivenessEffectiveness ofof HibHib AgainstAgainst PneumoniaPneumonia –– otherother studiesstudies BrazilBrazil –– CaseCase controlcontrol -- radiographicallyradiographically confirmedconfirmed pneumoniapneumonia byby WHOWHO criteriacriteria ConfoundersConfounders thatthat increasedincreased riskrisk inin casescases werewere fluflu –– likelike illnessillness inin pastpast 22 weeks,weeks, dayday –– carecare attendance,attendance, smokerssmokers atat home,home, andand lowerlower SESSES ControllingControlling forfor thethe aboveabove inin multivariatemultivariate analysisanalysis VEVE waswas 31%31% ((--9%9% -- 57%)57%) Lombok,Lombok, IndonesiaIndonesia –– nono efficacyefficacy againstagainst radiologicallyradiologically confirmed,confirmed, oror severe,severe, hospitalizedhospitalized pneumoniapneumonia –– 4%4% protectionprotection againstagainst highhigh burdenburden ofof clinicalclinical pneumoniapneumonia De Andrade et al, Int J Epidemiol, 2004, 33, 173 -81 Gessner et al, Lancet, 2005, 365, 43 - 52 10 PerPer ProtocolProtocol VaccineVaccine EfficacyEfficacy –– PneumoniaPneumonia –– CaliforniaCalifornia –– KidsKids << 55 YearsYears ofof AgeAge Cases / 1000 Cases / 1000 Vaccine 95% confidence person years person years efficacy interval in control in vaccine group group All clinical pneumonia 55.9 53.4 4.3 -3.5 – 11.5 Radiograph obtained 34.2 30.9 9.8 0.1 – 18.5 Point of Care Reading of 11.0 8.7 20.5 4.4 – 34.0 Consolidation WHO - - 30.3 10.7 – 45.7 Consolidation Black et al, PIDJ, 2002, 21, 810 – 15; Hansen et al, PIDJ, 2006, 25, 779-81. 11 VaccineVaccine EfficacyEfficacy AgainstAgainst VaccineVaccine--SerotypeSerotype SpecificSpecific IPDIPD InIn HIVHIV InfectedInfected (No(No ARV)ARV) andand HIVHIV UninfectedUninfected ChildrenChildren Incidence* Incidence* Efficacy VAR* Vaccinees Controls (95%CI) HIV Neg 7 39 83 (39, 97) 32 HIV Pos 300 870 65 (24, 86) 570 •Per 100 000 child years * VAR=Number of cases prevented per 100 000 child years Klugman KP et al NEJM 2003 12 VaccineVaccine EfficacyEfficacy –– FirstFirst EpisodeEpisode Pneumonia*Pneumonia* –– HIVHIV--veve CasesCases inin CasesCases inin VaccineVaccine 95%95% controlcontrol vaccinevaccine efficacyefficacy confidenceconfidence groupgroup groupgroup intervalinterval ITTITT 212212 169169 2020 22 -- 3535 PPPP 158158 119119 2525 44 –– 4141 * Pneumonia is defined by CXR findings of consolidation based on the WHO consensus document Klugman et al, NEJM, 2003, 349, 1341-8 13 VaccineVaccine EfficacyEfficacy AgainstAgainst RadiologicallyRadiologically ConfirmedConfirmed PneumoniaPneumonia Incidence* Incidence Efficacy VAR* Vaccinees Controls* (95%CI) SA: HIV Neg 390 490 20 (3, 35) 100 SA: HIV Pos 7 910 7 000 13 (-7, 28) 910 * Per 100 000 child years VAR= Number of cases prevented per 100 000 child years Klugman KP et al. NEJM 2003 14 VaccineVaccine EfficacyEfficacy AgainstAgainst AllAll LowerLower RespiratoryRespiratory TractTract InfectionInfection Incidence* Incidence Efficacy VAR* Vaccinees Controls (95%CI) SA: HIV Neg 2 400 2 570 7 (-1; 14) 170 SA: HIV Pos 14 150 16 720 15 (6, 24) 2 570 * Per 100 000 child years VAR= Number of cases prevented per 100 000 child years Madhi SA et al. Clin Infect Dis 2005 15 CRPCRP isis UsefulUseful toto DefineDefine PneumococcalPneumococcal PneumoniaPneumonia inin ChildrenChildren withwith LRTILRTI andand NONO ConsolidationConsolidation oror EffusionEffusion onon CXRCXR InIn HIVHIV uninfecteduninfected childrenchildren efficacyefficacy inin thisthis groupgroup withwith LRTILRTI waswas 2%(NS),2%(NS), butbut 32%32% (P(P == 0.007)0.007) inin thosethose withwith CRPCRP >> 4040 InIn HIVHIV infectedinfected childrenchildren efficacyefficacy inin thisthis groupgroup withwith LRTILRTI waswas 13%(NS)13%(NS) butbut 31%31% (P(P == 0.03)0.03) inin thosethose withwith CRPCRP >> 4040 Madhi, Kohler, Kuwanda, Cutland, Klugman, PIDJ, 2006, 25, 30 - 36 16 TheThe MostMost SensitiveSensitive DetectionDetection ofof PneumococcalPneumococcal DiseaseDisease inin InfantsInfants isis AnyAny InfiltrateInfiltrate onon CXRCXR PlusPlus CRPCRP >40>40 mg/Lmg/L CXRCXR -- ACAC VARVAR 100100 CXRCXR NoNo ACAC VARVAR 205205 CRPCRP >> 4040 CXRCXR ––ACAC ++ VARVAR 350350 AnyAny infiltrateinfiltrate CRPCRP >> 4040 Madhi & Klugman, Vaccine, 2007, in press 17 EfficacyEfficacy ofof 99--valentvalent ConjugateConjugate -- GambiaGambia (Per(Per Protocol)Protocol) Endpoint Vaccine Placebo Vaccine Efficacy n=8189 n=8151 (95% CI) Radiological pneumonia 207 323 37 (25 to 48) Clinical pneumonia 2172 2284 7 (1 to 12) Severe clinical pneumonia 172 192 12 (-9 to 29) VT invasive disease 9 38 77 (51 to 90) VT lung aspirate 3 11 73 (-2 to 95) Hospital admission 1065 1216 15 (7 to 21) All cause mortality 330 389 16 (3 to 28) Cutts et al, Lancet, 2005, 365, 1139 - 46 18 Differences in rates of pneumococcal and nonspecific pneumonia, otitis media, and other ARI visits in children <2 years old after the introduction of PCV7: US ambulatory settings Grijalva, C. G. et al. Pediatrics 2006;118:865-873 Copyright ©2006 American Academy of Pediatrics 19 Case Control Study of Risk Factors for Pneumococcal Bacteremia Nuorti et al, N Engl J Med, 2000, 342, 681-9. 20 Contact with a Child as a Risk for Pneumococcal Bacteremia in HIV Infected Patients Cases were HIV infected patients with pneumococcal bacteremia
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