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1、Hib - characteristics Gram negative cocco-bacilli carried by 3% to 15% of young children in the world causes disease in young children meningitis pneumonia epiglottitis septic arthritis第1頁/共30頁第一頁，共31頁。Hib disease Industrialized countries median age 1-2 years most meningitis then epiglottitis? menin

2、gitis mortality under 5% affects 1-2/1000 children Developing countries (Africa) median age 6-9 months most pneumonia, then meningitis meningitis mortality 20-50% affects 10/1000 children?第2頁/共30頁第二頁，共31頁。第3頁/共30頁第三頁，共31頁。Gambian PRP-T trial 42,000 infants randomized to receive PRP-T or placebo at 2

3、, 3 and 4 months of age population studied for: Hib meningitis Hib pneumonia all pneumonia Hib carriageGambia slides courtesy of Kim Mulholland, MD University of Melbourne第4頁/共30頁第四頁，共31頁。Study design individually randomized, double blind study major effort to detect Hib pneumonia randomization in 1

4、0 groups numbered 0 through 9:DTP + PRP-TDTP + placeboat 2, 3 and 4 months of age5 numbers5 numbers第5頁/共30頁第五頁，共31頁。Final results, March 199642,848 infants enrolled PRP-T group 21,490 infants 1272 possible Hib disease 616 chest radiographs 173 lumbar punctures 71 lung aspirates Control group 21,358

5、infants 1342 possible Hib disease 653 chest radiographs 192 lumbar punctures 75 lung aspirates第6頁/共30頁第六頁，共31頁。Did the vaccine actually prevent pneumonia? PRP-T controls vaccine efficacy episodes prevented WHO pneumonia* 526 570 8% 44 radiological pneumonia 132 170 22% 38 *cough + fast breathing or

6、lower chest wall indrawing第7頁/共30頁第七頁，共31頁。What did the Gambia trial tell us about the epidemiology of Hib pneumonia in West Africa? Hib is responsible for about 20% of radiological pneumonia in Gambian infants Previous studies had suggested 5-10% of pneumonia due to Hib Very little “WHO pneumonia”

7、which is not radiologically obvious is due to Hib第8頁/共30頁第八頁，共31頁。Conclusions PRP-T effectively prevented meningitis and pneumonia due to Hib in The Gambia Hib vaccines have been proven in Finland, USA, UK, Chile and other countries Why arent Hib vaccines used everywhere?第9頁/共30頁第九頁，共31頁。第10頁/共30頁第十

8、頁，共31頁。Why are Hib vaccines not used all over the world? cost varies, currently $2 per dose affordable for most Asian countries understanding of burden of disease is the major problem in Asia第11頁/共30頁第十一頁，共31頁。Asia Many Asian countries can afford Hib vaccine Hib was known to be an important cause of

9、 bacterial meningitis in Asia But: Microbiologically confirmed Hib incidence lower than elsewhere ( one color vaccine Average age at enrollment (i.e., first vaccine plus 2 week delay): 13 weeks第19頁/共30頁第十九頁，共31頁。OutcomePrevented proportionControl group incidenceHib Vaccine group incidencePrevented H

10、ib incidence (95% CI)-43 (-185 to 98)52 (-194 to 298)174 (-153 to 500)264 (-101 to 629)1561 (270 to 2,853)1+ vaccine dosesRadiologically confirmed-4.90%893936Any infiltrate on chest radiology1.90%2,6772,625Hospitalized severe pneumonia3.80%4,5184,345Any severe pneumonia4.80%5,4605,196Clinical pneumo

11、nia4.00%39,51637,954All incidences are per 100,000 child-yearsPneumonia Outcomes第20頁/共30頁第二十頁，共31頁。OutcomePrevented proportionControl group incidenceHib Vaccine group incidencePrevented Hib incidence (95% CI)-89 (-248 to 71)-36 (-322 to 249)-49 (-416 to 318)6.9 (-401 to 415)1,467 (-60 to 2,994)3 vac

12、cine dosesRadiologically confirmed-12.0%770859Any infiltrate on chest radiology-1.5%2,4682,504Hospitalized severe pneumonia-1.3%3,9063,955Any severe pneumonia0.15%4,7124,705Clinical pneumonia3.8%38,22636,759All incidences are per 100,000 child-yearsPneumonia Outcomes第21頁/共30頁第二十一頁，共31頁。OutcomePreven

13、ted proportionControl group incidenceHib vaccine group incidencePrevented Hib incidence (95% CI)16 (1.4 to 31)47 (13 to 81)67 (22 to 112)89 (10 to 167)158 (42 to 273)Meningitis admission or clinic evaluation for seizures22%701543Lumbar punctures26%346258Possible bacterial (incl. conf. Hib)50%13467Pr

14、obable bacterial (incl. conf. Hib)55%86391+ vaccine dosesMicrobiologically confirmed Hib86%192.6All incidences are per 100,000 child-yearsMeningitis Outcomes第22頁/共30頁第二十二頁，共31頁。OutcomePrevented proportionControl group incidenceHib vaccine group incidencePrevented Hib incidence (95% CI)20 (-0.42 to 4

15、0)45 (3.9 to 86)74 (19 to 128)52 (-41 to 144)129 (-6.7 to 265)3 vaccine dosesMicrobiologically confirmed Hib84%233.7Probable bacterial (incl. conf. Hib)57%7834Possible bacterial (incl. conf. Hib)54%13764Lumbar punctures16%317265Meningitis admission or clinic evaluation for seizures20%656527All incid

16、ences are per 100,000 child-yearsMeningitis Outcomes第23頁/共30頁第二十三頁，共31頁。RegionCountryRateNorth AmericaU.S.11 - 64South AmericaBrazil5 - 44EuropeIceland43Bulgaria6.1AfricaGambia57 - 60South Africa34Middle EastSaudi Arabia45Kuwait15AsiaChina8Hong Kong, Taiwan1Lombok (Based on under 2 rates, 1+ doses)6

17、3Published rates of Hib meningitis(Children under 5 years per 100K person-years)第24頁/共30頁第二十四頁，共31頁。第25頁/共30頁第二十五頁，共31頁。59 (-249 to 367)-4.9 (-136 to 126)-4.5 (-147 to 138)66 (-126 to 259)40 (-17 to 97)Preventable Hib mortality (95% CI)Meningitis admission or seen at health center for seizures25.0%1

18、61121Clinical or verbal autopsy-defined pneumonia6.5%1,020954Clinical pneumonia-0.7%601606WHO-defined severe pneumonia-0.9%526531All deaths3.0%1,9361,877OutcomePrevented proportionControl group mortalityHib Vaccine group mortalityMortality rates are per 100,000 child-yearsMortality after at least 1

19、dose第26頁/共30頁第二十六頁，共31頁。30 (-201 to 261)-4.8 (-109 to 99)-14 (-124 to 96)19 (-126 to 164)75 (8.1 to 141)Preventable Hib mortality (95% CI)Meningitis admission or seen at health center for seizures46.0%16186Clinical or verbal autopsy-defined pneumonia3.3%583564Clinical pneumonia-4.2%341355WHO-defined

20、 severe pneumonia-1.6%305310All deaths2.6%1,1551,125OutcomePrevented proportionControl group mortalityHib Vaccine group mortalityMortality rates are per 100,000 child-yearsMortality after 3 doses第27頁/共30頁第二十七頁，共31頁。Conclusions Hib vaccine not an effective intervention against ALRI (pneumonia) in Lom

21、bok Hib meningitis burden underestimated by microbiology true burden 10X greater Hib vaccine may significantly reduce meningitis mortality 1 in 33 unvaccinated children on Lombok develop invasive Hib disease before age 2.第28頁/共30頁第二十八頁，共31頁。Comparison of Gambia and Lombok Results Hib vaccine prevent

22、s about 20% of radiological pneumonia in Gambian infants Very little “WHO pneumonia” which is not radiologically obvious is due to Hib Protection conferred after 3rd dose Hib vaccine prevents little to no radiological pneumonia in Lombok infants The predominant pneumonia prevented by Hib vaccine is

23、non-severe WHO pneumonia. Protection conferred after first dose. For every case of laboratory-diagnosed Hib disease on Lombok, there were 10 cases of Hib meningitis, and 100 cases of Hib pneumonia.GambiaLombok第29頁/共30頁第二十九頁，共31頁。感謝您的觀看(gunkn)！第30頁/共30頁第三十頁，共31頁。NoImage內(nèi)容(nirng)總結(jié)Hib - characteristics。affects 1-2/1000 children。affects 10/1000 children。Gambian PRP-T trial。DTP + PRP-T。55,073 enrolled infants。感謝您的觀看(gunkn)第三十一頁，共31頁。