fffi$ l(actine Meninoitis I
Health q)Proiect World
fFf?fithr Joint News ReleaseWHO/28 8 June 2OO7
Organization
EMBARGO: NOT FORRELEASE BEFORE DAY JUNE8, 2OO7, OO:01 GMT
IMPROVED MENINGITIS VACCINE FORAFRICA COULD SIGNAL EVENTUAL ENDTO DEADLY SCOURGE Successful Vaccine Trial Promises Long-Term, Low-Cost Protection From Epidemics in Africa GENEVA - The Meningitis (MVP)todayreleased Project Vaccine of newdata on the performance vaccinein West Africanchildren, a meningitis suggesting that the new vaccine+xpected to sell for 40 US centsa dose-will be muchmoreeffective initially and their in protecting Africanchildren than any vaccine communities on the marketin the region. cunently MVP, a partnershipbetweenthe World Health Organization (WHO) and the Seattle-based nonprofit, PATH,is collaborating witha vaccineproducer, SerumInstitute of IndiaLimited(SllL), to produce the new vaccine against serogroupA Ner.ssenameningitidis (meningococcus).The preliminary resultsof theirstudy,a Phase2 vaccine trial, revealthat the vaccinecouldeventually slash the incidence in the "meningitis of epidemics belt,"as 21 affectednationsof sub-Saharan Africa are collectively known.The vaccineis expectedto block infectionby the serogroup A meningococcus,and therefore extend protection to the entire population, including the a phenomenon unvaccinated, knowas "herdimmunity." "When it becomespart of the publichealth arsenal,this vaccinewill make a real differencein Africa," said Dr. F. Marc LaForce,MVP director."The vaccinewill allow eliminationof the meningococcal epidemics that haveafflicted the continent for morethan100years." The new meningococcal vaccine in Mali and The Gambia, conjugate trial,in 12- to 23-month-olds showsthat the vaccinewas safe,andthat it produced antibody levelsalmost 20 timeshigher than those obtainedwith the marketedpolysaccharide (un-conjugated) vaccine. This means that protection fromserogroup A meningococcal meningitis is expected to lastfor severalyears. "Thisimportant and young study bringsreal hopethat the livesof thousands teenagers, of children, adultswill be saved by immunization and that widespread suffering, sicknessand socioeconomic disruptioncan be avoided,"said Dr. MargaretChan, Director-General of the World Health Organization. "Elimination of these epidemics vaccineis now a A conjugate withwide use of the meningococcal "Peoplebetweenthe ages of 1 and 29 likefypossibility over the next few years,"said LaForce.
Joint News Release WHO/28 Page 2 yearsof agewill be protected by receiving a single dose in largemassvaccination campaigns. The largecampaigns are expected to createherd immunity, and eventually, of the disease." elimination preliminary As a resultof the encouraging findings of this Phase2 clinical study,SllL and MVP will proceed with a Phase 2/3 study where the vaccinewill be tested in 2- to 29-year-olds-the population that will be mostlytargetedby massvaccination campaigns. Testingwill take place in Mali,The Gambia,andat leastone otherAfrican country. An additional studyis plannedfor clinical thissummerin India, where the vaccine will be licensed. "Serum Institute of lndiais dedicated products to developing safe, effective, and affordable for the poorest countriesin the world," said Dr. Cyrus Poonawalla, Chairmanof SllL. "These results confirm and extend the observations made last year in our Phase 1 study in India.The new conjugatevaccine has an excellentsafety profilein young children,and it is immunologically superiorto the polysaccharide vaccine." A conjugatevaccine joins (or "conjugates") sugarsfrom the meningococcal bacteriumwith a protein,which in turn stimulates immunecells.Thesecells then produce to meningitis, antibodies protecting the individual participated from infection. A totalof 600 toddlers in the Phase2 study. They were enrolledat two clinicalsites in Africa: (CVD)-Mali Centerfor VaccineDevelopment and the Medical ResearchCouncil(MRC) Laboratories in The Gambia.Dr. Brown Okoko, principal at the MRCsite in Basse,said, "Theclinical investigator identifywith teamsat MRCand CVD-Mali the vision,mission, and mandate of the Meningitis VaccineProject. We are all highlymotivated and very proud to be able to contribute of a vaccinethat is critically needed in to the development Africa." Dr. SambaSow, principal investigator in at GVD-Mali, said, "Someof the familieswho participated the study have lost several members Thosewho have of theirfamilyto meningococcal meningitis. not been directlyaffected Thereis knowthe tenible impact that the diseasehason the community. for the clinical a lot of support studyand the newvaccine in the Bamako community." International, |GATEClinicalResearch research company in Mumbai,India,is providing a contract datamanagement services. "Theplansfor the futureare quiteambitious," "Withthe successful completion of the saidLaForce. year plan 2 study, study next in a and funding we a demonstration Phase once is secured, to do public-health the hyperendemic countrywhere we will take the vaccineto scale by immunizing between to go well in testingand duringthe entirepopulation the ages of 1 and 29. lf all continues demonstration study,the new vaccine,which will be pricedat about40 cents per dose,could be in Africawithin introduced the nexttwo to threeyears." is an infection of the meninges, the thinliningthat sunounds the brain and spinalcord. lt Meningitis treatment, at least 10 Even with antibiotic diseases. is one of the world's mostdreadedinfectious problems,such as mental percentof patients die, with up to 20 percentleft with permanent deafness, leading epilepsy, to limbamputation. retardation, or necrosis groups areA, B, C, Y, and W135.While groupsA, B, and C of meningococci The most prominent group A causesdeadly,explosive epidemics for the majority of cases worldwide, are responsible "meningitis beft,"an area that in what is knownas the African every8 to 10 years predominantly in the East.The belthasan at-risk from Senegaland The Gambiain the Westto Ethiopia stretches in historysweptacross population wave ever recorded of about 430 million. The largestepidemic 25,000 cases and deaths. region in 1996-1997, 250,000 causing over the entire reportedcasesand the but lastyea/s 41,526 sparedin recentyears, Africahas been relatively wavemay from 1 January casesreported to 6 May2007bringthe fearthata new epidemic 47,925 Africa. havebegunin sub-Saharan
Joint News Release WHO/28 Page 3 Earlierthis year,as an epidemic was ragingin Burkina Faso, MVP partnered with Rockhopper TV to producea documentary on meningococcal meningitis for BBC's Kitl or Cure series.The film offersa poignant and revealing accountof the devastating impactmeningitis have on epidemics individuals, families, and communities. The filmalsotakesviewersto Maliwhere the newvaccineis beingtested.Thefilm will be broadcast on BBCWorldJune 8-13, and lateravailable on DVD and the MVPwebsite. The Meningitis Vaccine Project (MVP - http://www.meninovax.orq) is a partnership betweenthe World Health Organization (WHO)and PATH.lt was estabtished in May 20Ol through a US$70millionseed grant fromthe Bill & Melinda GatesFoundation. The mission of MVPis to eliminate meningitis as a public epidemic healthproblemin sub-Saharan Africathroughthe development, testing,introduction, and widespread use of conjugate meningococcal vaccines. The World Health Organization(WHO - hftp://www.who.int), the UnitedNations' specialized agencyfor health, was established on 7 April1948.WHO'sobjective, is the attainment as set out in its Constitution, by all peoples of the highest possible levelof health,defined physical, mentaland social as a stateof complete well-being and notmerely theabsence of disease or infirmity. PATH (htto//www.oath.orq) is an international, nonprofit organization culturally that createssustainable, relevantsolutions,enablingcommunities worldwideto break longstanding cycles of poor health. By collaboratingwith diverse public- and private-sector partners, PATH helps provide appropriate health technologies andvitalstrategies thatchange the waypeople thinkand act. Created in 1967,Serum Instituteof India Limited (SllL- hfto:l/www.seruminstitute.com) has emerged as a top supplierof qualityvaccines and the world's largestmanufacturer vaccineand diphtheriaof measles (DTP)vaccines. tetanus-pertussis Cunently, At leastone SllL products are beingexported to 150 countries. of twochildren bornthroughout world the is administered by SllL. a measles or DTPvaccine manufactured The Centre pour le D6veloppementdes Vaccins-Mati(Center for Vaccine Development-Mali-CVDMali) was createdin 2000 under a cooperative agreement with the MalianMinistryof Health and the University of Maryland for VaccineDevelopment. Center is headquartered at the CentreNational CVD-Mali d'Appui d la Luttecontrela Maladie (formerly in Bamako, of the Ministry Institut Marchoux) andit is a division of Healthin Mali.The focusof CVD-Mali is to conductresearch and and provide trainingin vaccinology tropicaldiseases in the country. The Medical Research Council (MRC) Laboratories(htto:i/www.mrc.qm), the The Gambia, represents UnitedKingdom's major publicinvestment The unit has been in developing in medical research countries. established 60 years ago andworksclosely has with thegovernment of The Gambia. The MRC Laboratories a longtrack recordof research on vaccines Majorstrengths for infectious diseases. of the unit includea multidisciplinary approach, relationships with the field, clinical,and laboratory combining facilitiesand excellent community. |GATEClinical Research International(iCRl - htto://www.ioate.com/icri) is a full service contractresearch company with offices in Indiaand the UnitedStates. services, |GATECRI offersclinical trial management including clinical operations, central laboratory services, data management and biostatistics, pharmacovigilance, pharmacy providing servicesto global India-specific and regulatory support, consultancy clients. For further information, contact: BumessCommunications: Coimbra Sirica+1 631 757 4027,csirica@bumesscommunications.com ; CarolVieira+1 401 714 0821,cvieira@bumesscommunications.com Meningitis Vaccine Project Monique Berlier- cell +33 6 33 1887 70;wk +33 4 50 280822, mberlier@oath.oro WorfdHealthOrganization +41 22 79144 68,bruniera@wtto.int Initiative for Vaccine AlisonBrunier, Research:
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pouRRAtr uNMETLLEUR vAccrN coNTRE LAnrtErurrucrE MARQUER ENAFRteuE LA FrN DEce rIEAU MoRTEL Des essaisprometteurslaissentpr6sagerune protectionde longuedur5e et peu co0teuse contre les 6pid6miesen Afrique (MVP)a publi6aujourd'hui CenEVe - Le ProjetVaccins donn6es M6ningite de nouvelles d'o0 il leseffetsd'unvaccin concernant en Afriquede l'Ouest, contrela m6ningite chezles enfants - qui devrait6trevenduau d6partau prixde 40 US centsla dose ressortquece nouveau vaccin prot6gera que toutautrevaccin lesenfantsafricains bienplusefficacement et leurscommunaut6s sur le march6 actuellement dansla r6gion. partenariatentre I'Organisation Le Projet Vaccins M6ningite, mondialede la Sant6 (OMS) et I'organisation d but non lucratifPATH,bas6ed Seattle,collabore avec un fabricantde vaccins, Serum Institute of lndia Limited (SllL), pour produire le nouveauvaccin contre Neisseria (m6ningocoque) pr6liminaires meningitidis de leur 6tude,un essai A. Les r6sultats du s6rogroupe de vaccinde phase 2, r6vdleque le vaccinpourrait au bout du compter6duireconsid6rablement qui regroupe les 21 paysde l'Afrique l'incidence des 6pid6mies dansla "ceinture de la m6ningite," du sub-saharienne du dangereuxm6ningocoque affect6s.Congupour bloquerla transmission appel6 s6rogroupe A, ce vaccindevrait dtendrela protection aux sujetsnonvaccin6s,ph6nomdne "immunit6 collective." "Lorsqu'ilsera devenu un 6l6mentde I'arsenal ce vaccin fera vraiment la de sant6 publique, "Ce VaccinsM6ningite. en Afrique," le Dr. F. MarcLaForce, Directeur du Projet diff6rence a d6clar6 plus depuis dont souffrele continent vaccinpermettra m6ningococciques d'6liminer les 6pid6mies de 100ans." 6g6sde P e23 moisau Maliet en Gambie, Le nouvelessaide vaccinconjugu6, chez des enfants presque que qu'il produit 20 fois plus6lev6sque le vaccinest sOret ddmontre destauxd'anticorps (non-conjugu6) Cela signifieque la commercialis6. ceux obtenus d l'aide du vaccinpolyosidique ann6es. protection durerplusieurs A devrait contrela m6ningite du s6rogroupe d m6ningocoque permettra les vies d'6pargner "Cetteimportante que la vaccination esp6rer 6tudelaisser6ellement jeunes de que souffrances, d'6normes et milliers d'enfants, et adultes de d'adolescents de le a d6clar6 perturbations 6vit6es," que seront nombreuses maladiesainsi des socio-6conomiques g6n6ral de la Sant6. mondiale Chan, Directeur de I'Organisation Dr. Margaret
Gommuniqu6 de presse conjoint OMS/2g Page 2 "L'6liminationde ces 6pid6mies en recourant largement au vaccin conjugu6 contre le meningocoque A est d6sormais probable "Les d'iciquelquelann6es," a pr6cis6fe bi LaForce. sujets 6g6s de 1 e 29 serontproteg6spar I'administration d'une dose unique dans le cadre de campagnes de vaccination de masse.Ces grandes campagnes devraient engendrer une immunit6 collective et, au boutdu compte, l'6limination de la maladie." A la suite des r6sultats pr6liminaires de l'6tudecliniquede phase 2, SllL et le ProjetVaccins M6ningiteprocdderont d une 6tudede phase 213 au coursde taquelle le vaccin seraexperiment6 sur des sujets 6g6sde 2 e 29 ans - population appel6e d €trela pluscibl6epar lescampagnes de vaccination de masse. Les essaisaurontlieuau Mali,en Gambie et dansau moinsun autrepays africain.Une 6tudecliniquesuppt6mentaire est pr6vuepour cet 6t6 en lnde, oir le vaccinsera homologu6. "Serum Institute of Indiase consacre d la miseau pointde produits sOrs, efficaceset abordables pour les paysles plus pauvres du monde," a d6clar6le Dr. CyrusPoonawalla, de SllL. Pr6sident "Ces r6sultats confirment et 6largissent les observations faites I'ann6e dernidreau coursde notre 6tude de phase1 en Inde. Le nouveauvaccinconjugu6a un excellent profil d'innocuit6 chez le jeuneenfant et il est sup6rieur point polyosidique." du de vueimmunologique au vaccin Un vaccinconjugu6 combine les sucresde la bact6rie m6ningococcique ce qui avec une prot6ine, a pour effetde stimuler les cellules produisent de I'immunit6. contre Ces cellules alors des anticorps prot6geant la m6ningite, l'individu de I'infection. Au total, 600 trds jeunesenfants ont particip6d l'6tudede phase 2. lls ont 6t6 enr6l6sdans deux sites cliniques en Afrique: Le Centrepour le d6veloppement (CVD)au Maliet les Medical des vaccins (MRC) Laboratories Research en Council Gambie. Le Dr. Brown Okoko,chercheurprincipal au site des MRC i Basse, a d6clar6:"Les 6quipes cliniques des MRCet du CVD-Mali du s'identifient d I'ambition, i la missionet au mandat Projet Vaccin contre la M6ningite.Nous sommestous fortementmotiv6s et trds fiers d'6tre capables de contribuer d la miseau pointd'unvaccindontI'Afrique a un urgentbesoin." Le Dr. Samba Sow, chercheur principalau CVD-Mali, a d6clar6:"certainesdes famillesayant particip6d l'6tudeavaientd6jd perduplusieurs de leurs membres des suites de la m6ningited m6ningocoque. Cellesqui n'enont passouffert terribles directement connaissent les cons6quences de cette maladiepour la communaut6. de Bamako La communaut6 a amplementsoutenul'6tude clinique et le nouveau vaccin." |GATEClinical ResearchInternational, une entreprise de recherche souscontrat bas6ed Mumbai, en Inde,assureles services de gestion des donn6es. "Les projetsd'avenirsont fort ambitieux," "Unefois l'6tudede phase2 le Dr LaForce. a expliqu6 le termindeet financement assur6,nous pr6voyons d une 6tude de d6monstration de proc6der prochaine l'ann6e de dansun payshyperend6mique au vaccin unedimension oi nousdonnerons sant6publique en vaccinant d aller la totalit6 dg6ede I e 29 ans. Si tout continue de la population bien au coursde l'exp6rimentation le nouveauvaccin,dont le prix et de l'6tude de d6monstration, de 40 centsla dose,pounait€treintroduit serade I'ordre en Afrique d'icideuxou troisans." est une infection qui entoure La m6ningite le cerveauet la moelle le fin rev6tement des m6ninges, 6pinidre.ll s'agit d'une des maladies MOmeavec un traitement infectieuses les plus redout6es. des au moins 10 pour cent des maladesen d6cddent, antibiotique, et 20 pour cent conservent s6quellespermanentes,telles qu'arri6ration mentale,surdit6,6pilepsieou n6croseentrainant de membres. l'amputation groupesde m6ningocoques Les principaux A, B, C, Y et W135. Alors que les sontles groupes groupesA, B et C sont responsables dans le monde, le des cas qui surviennent de la majorit6 dans groupeA provoquedes 6pid6mies tous les 8 d 10 ans, principalement et mortelles explosives la et de qui du S6n6gal une zone ce que I'onappelle la "ceinture s'6tend africaine, de la m6ningite" 430 population d'environ d risque Gambied I'ouest d I'Ethiopie d I'est.La ceinturecompteune
Communiqu6 de presse conjoint OMS/28 Page 3 jamaisenregistr6e millionsd'habitants. La plusgrandevague6pid6mique a balay6la r6giontoute provocant plusde 250 000cas et 25 000 d6cds. entidreen 1996-1997, L'Afrique a 6t6 relativement I'an 6pargn6e ces dernidres ann6es,mais les 41 526 cas enregistr6s dernieret les 47 925 cas enregistr6s entre le 1"' janvieret 6 mai de cette ann6efont craindre qu'unenouvelle vague6pid6mique ait prisnaissance en Afrique subsaharienne. I
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Au d6but de cette ann6e,alors qu'uneepid6mie faisaitrage au BurkinaFaso, le ProjetVaccins M6ningites'est alli6 a Rockhopper TV afin de produireun documentaire sur la m6ningiteit pour la s6rieKll or Curcde la BBC.Ce film rend comptede manidrepoignante m6ningocoque et pour les individus, les r6v6latrice des cons6quences d6sastreuses des 6pid6mies de m6ningite familleset les communaut6s. vaccin au Mali,o0 le nouveau Ce film emmdne aussiles spectateurs juin, puis sera 13 est en cours d'exp6rimentation. BBC du 8 Le film sera diffus6sur World au disponible en DVDet sur le sitedu ProjetVaccins M6ningite. mondialede la Le Projet Vaccins M6ningite (MVP- http:/Alww.meninqvax.oro) entreI'Organisation est un partenariat Bill& Melinda Sant6(OMS)etPATH.ll a 6t6 cr66en mai2001gr6ced un don initial de US$70millions de la Fondation Gates. Sa mission est d'6liminerla m6ningite6pid6miqueen tiant que probldmede sant6 publiqueen Aftique gr6ced !a miseau point,d l'exp6rimentation, de vaccins subsaharienne et d I'utilisation d grandeechetle drl'introduction conjug6s contrele mdningocoque. Uniesen charge L'Organisationmondiale de la Sant6(OMS- hfto://www.who.int), des Nations organisation sp6cialis6e tous les peuples de la sant6,a 6t6 cr66e te 7 avril 1948.Le but de I'OMS, est d'amener tel que le d6finitsa constitution, mentalet au niveaude sant6le plus 6lev6possible, bien-€trephysique, la sant66tantd6finie commeune 6tat de complet socialet passeulement I'absence de maladie ou d'infirmit6. durableset PATH (http://www.oath.oro) est une oryanisation intemationale sans but lucratifqui proposedes solutions pertinentespermettant culturellement aux communaut6s de briser le vieux cercle vicieuxde la mauvaisesant6. En et des appropri6es publicset priv6s, PATHcontribued foumir des technologies avec divers partenaires collaborant vitalesqui modifientlesfagons strat6gie de penseret d'agir. est devenul'undes principaux Creeen 1967,le Serum Institute of India Limited (SllL- htto://www.seruminstitute.com) foumisseurs de vaccinsde qualit6 et le plusgrandfabricant au mondede vaccinscontrela rougeoleainsique de vaccins (DTC).Sesproduits vers 150pays. Au moinsun enfantsur antidipht6rique-antit6tanique-anticoquelucheux sont export6s par SllL. deuxqui naitd traversle mondese voir administrer ou DTCfabriqu6 antirougeoleux un vaccin Le Centre pour le D6veloppementdes Vaccins-Mali- GVD-Mati)a 6t6 cr66 en 2000 au termesd'un accord de ll de Maryland. de l'Universit6 entle le Ministdremalien de la sant6et le Centre coop6ration de miseau pointde vaccins et constitue (anciennement Marchoux) d Bamako Institut est situeau CentreNationaldAppuid la Luttecontrela Maladie dans le et dispenseune formation du Ministdrede la sant6du Mali.Le CVD-Mali une division mdnedes recherches desvaccins domaine tropicales et desmaladies dansle pays. Les Medical Research Council (MRC) Laboratories (htto://www.mrc.qm), en Gambie, constituentle principal lls ont 6t6 public investissement m6dicale dans le mondeen d6veloppement. du Royaume Uni en matidrede recherche MRC ont une gambien. Les Laboratoires mis sur pied il y a 60 ans et collaborent 6troitement avec le gouvemement atouls sont Leurs principaux infectieuses. longueexp6rience en matidrede recherche contreles maladies sur les vaccins pluridisciplinaire qui allie installations ainsi que leurs excellentes et laboratoires, de tenain,cliniques une approche relations avecla communaut6. sous contrat de recherche |GATEGlinical Research Intemational(iCRl - http://www.ioate.com/icri)est une entreprise de gestion qui possddedes bureaux polyvalente |GATECRI proposedes services en Indeet aux EtatsUnisdAm6rique. et gestion des donn6es laboratoire, d'essais cliniques, notamment op6rationscliniques, services centraux de tout en dispensant pharmacovigilance, pharmaceutiques et conseilen matidrede r6glementaire, biostatistique, services en relationavecl'lnded ses clientsd traversle monde. des conseils Pour de plus amples informations,veuillezcontacter: CarolVieira+1 401 Communications: Bumess Coimbra Sirica+1 631 7574027,csirica@burnesscommunications.com; cvieira@bumesscommunications.com 714 0821, +336 33 1887 70;postefixe+334 50 28 0822, mberlier@Bath,oro Projet M6ningite : Monique Vaccins Berlier- portrable mondialede la Sant6, Alison Brunier, +41 22 791 44 68, Initiativede recherche sur les vaccinsde I'Organisation bruniera@who.int.