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kvlevebi axali TB vaqcinis Sesaqmnelad

kvlevebi axali TB vaqcinis Sesaqmnelad. tfdec; samecniero seminari; “samSabaToba”; neli solomonia; 08.12.09. BCG vaqcina 88 wlis win Seiqmna. Calmette & Guérin 1908-1921. XXI saukune 2006-2015. $3.641 billion. TB pandemiis winaaRmdeg BCG araefeqturi aRmoCnda.

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kvlevebi axali TB vaqcinis Sesaqmnelad

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  1. kvlevebiaxaliTBvaqcinisSesaqmnelad tfdec; samecniero seminari; “samSabaToba”; neli solomonia; 08.12.09

  2. BCGvaqcina 88 wlis win Seiqmna Calmette & Guérin 1908-1921 XXI saukune 2006-2015 $3.641 billion

  3. TB pandemiiswinaaRmdegBCGaraefeqturiaRmoCnda farTo gamoyenebis miuxedavad BCG-bam TBSemTxvevebis globalur zrdaze mniSvnelovani zegavlena ver moaxdina; BCGvercerT asakSi saimedod ver icavsorganizms TB-is ganviTarebisagan; BCG bavSvs mxolod TB diseminirebuli formebis da TB meningitis ganviTarebisagan icavs ; BCG ver icavs organizms LTBI-isagan;

  4. aiv-inficirebuli bavSvebis BCG-ireba saxifaToa tubsawinaaRmdego vaqcinacia, romelic rutinulad utardeba msoflioSi dabadebul CvilTa 75%-s, aiv-inficirebuli CvilebisaTvis maRal risks warmoadgens (yovel 100 000 mosaxleze aivinficirebulTa 992 SemTxvevaSi BCG-irebam TB diseminirebuli formebis ganviTareba gamoiwvia (95% CI: 567–1495)Hesseling et al Bulletin of the World Health Organization; Type: Research Article DOI: 10.2471/BLT.08.055657 2009), amitom janmo iZleva rekomendacias aiv testirebis gareSe Cvilebis BCG-ireba ar Catardes; - 02.07.09; WHO.

  5. axaliTBvaqcinis aucilebloba • TB globaluri miznis miRweva (>1 TB SemTx./milion mosaxleze) axali vaqcinis, anu daavadebis prevenciis gareSe SeuZlebelia; • aucilebelia TB axali, ekonomiuri, efeqturi vaqcina, romelic saimedod daicavs: • nebismieri asakis organizms; • maT Soris HIV-inficirebulebs; da uzrunvelyofs: • LTBI_is prevencias (preinfeqciuri vaqcinacia); • LTBI-is reaqtivaciis prevencias (postinfeqciuri vaqcinacia); • TB pirveladi da meoradi, maT Soris MDR/XDR formebisprevencias; • TB mkurnalobis xangrZlivobis Semcirebas da TB mkurnalobis efeqturobis zrdas (imunoTerapia).

  6. Aeras Global Vaccine Development Partners Foundations/ Governments/ NGOs Bill & Melinda Gates Foundation, U.S. Ministry of Foreign Affairs of Denmark The Netherlands Ministry of Foreign Affairs, the Netherlands Centers for Disease Control and Prevention (CDC),U.S. Fogarty International Center and NIAID, National Institutes of Health, U.S. Research Council of Norway, Norway AIDS Fondet, Denmark Cambodian Health Committee, Cambodia European and Developing Countries Clinical Trials Partnership (EDCTP), European Commission LHL/ The Norwegian Association of Heart and Lung Patients, Norway Planeta Salud, Spain Manhiça Health Research Centre, Mozambique Medicine in Need (MEND), U.S. Stop TB Partnership, Switzerland TB-Alert, United Kingdom Tuberculosis Vaccine Initiative (TBVI), Europe Wellcome Trust, United Kingdom Academia Oxford University, United Kingdom South African TB Vaccine Initiative (SATVI), South Africa St. Johns Research Institute, India Makerere University, Uganda Kenya Medical Research Institute, Kenya Karolinska Institute, Sweden Wuhan University, China Albert Einstein College of Medicine, U.S. Arizona State University, U.S. Biomedical Primate Research Center, the Netherlands Case Western Reserve University, U.S. Central Institute for Tuberculosis, Russia Centre for International Health, University of Bergen, Norway Colorado State University, U.S. Emory University, U.S. Food and Drug Administration, U.S. Foundation for Innovative New Diagnostics (FIND), Switzerland Harvard University, U.S. International AIDS Vaccine Initiative (IAVI), U.S. Johns Hopkins University, U.S. KNCV Tuberculosis Foundation, the Netherlands Leiden University Medical Center, the Netherlands Life Science Research Israel (LSRI), Israel Max Planck Institute for Infection Biology, Germany McGill University, Canada National Cancer Institute (NKI), the Netherlands New York University, U.S. Oregon Health Sciences University, U.S. Public Health Research Institute, U.S. Stanford University, U.S. Saint Louis University., U.S. University of Bergen, Norway University of California-Davis, U.S. University of California-San Francisco, U.S. University of Maryland, College Park, U.S. University of Tampere, Finland University of Wales, United Kingdom Vanderbilt University., U.S. Walter Reed Army Institute of Research, U.S. Aeras Foundations/Government/NGOs Academia Industry Industry GlaxoSmithKline Biologicals, Belgium Crucell, the Netherlands Statens Serum Institute, Denmark ImmunoBiology, United Kingdom Wuhan Institute of Biological Products, China Serum Institute, India Thymed, Germany Alphalyse, Denmark Japan BCG Laboratory, Japan Korean Institute of TB, Korea Cyncron, Denmark Cellestis, Australia Immune Solutions, New Zealand Larimer, U.S. Sanofi Pasteur, France Smittskyddsinstitutet, Sweden BIOCON, U.S. Emergent BioSolutions, U.S. Intercell, Austria Spring Valley Laboratories, U.S.

  7. Aeras TB axali vaqcinis klinikuri kvlevebis partniorebi Cambodian Health Committee Cambodia St John’s Research Institute India KEMRI/CDC Kenya Manhiça Health Research Center Mozambique Makerere University Uganda SATVI/University of Cape Town South Africa

  8. TB axali vaqcinis Seqmnisken mimarTuli “Prime-Booster” strategiis Sedegad 2050 wlisaTvis TB avadoba da sikvdilianoba mxolod axali TB vaqcinebis xarjze 1/3-iT unda Semcirdes.

  9. axali TB vaqcinis Seqmnis Tanamedrove strategia principulad gansxvavebulia: I mimarTuleba gulisxmobs rekombinirebuli BCG vaqcinis Seqmnas Cvilebis preeqspozi-ciuri imunizaciasaTvis; II mimarTleba gulisxmobs virusiT veqtorire-buli, baqteriuli kapsidiT (nukleokapsiduri), an cilovani SenaerTebiT rekombinirebuli vaqcinebis Seqmnas Cvilebis, mozardebis, axalgazrdebis, maT Soris aivinficirebulebis posteqspoziciuri imunizaciasaTvis; postinfeqciuri vaqcinaciaLTBI-is reaqtivaciis prevenciisken aris mimarTuli da aqtiuri TB-is ganviTarebas 30-40%-iT Seamcirebs.

  10. Block Initial Infection Prevent Latent Infection Prevent Early Disease Prevent Reactivation Disease

  11. pre - da post-eqspoziciuri(infeqciuri) vaqcinacia, imunoTerapia? TB deaths TB deaths Birth uninfected Transmission non-infectious TB infected: latent X X X ? infectious TB X X relapse? pre-exposure primary TB primary TB post-exposure therapeutic? cure

  12. imunizaciisPrime –Boost reJimebiCvilebisaTvis Recombinant BCG IM or as an aerosol Capsids in bacteria orally or as an aerosol 14- 24 Weeks 10 -14 Weeks

  13. warsulSi BCG-irebuli mozardebis da mozrdilebis imunizacia Viral Vector rProtein + Adjuvant rProtein + Adjuvant Viral Vector IM or as Aerosol Viral Vector IM or as Aerosol Viral Vector 2 Viral Vector 1 Viral Vector 2 Capsids in bacteria or as Aerosal Capsids in bacteria or as Aerosal

  14. TB axali vaqcinis formebi • rBCGrekombinirebuli formebi BCG -sagan gansxvavdebian genebiT,romlebic ESAT-6 (early secretory antigen target 6) daCFP-10 (culture filtrate protein 10)antigenebis sekreciaze arian pasuxismgebelni. es antigenebi ujreduli imunitetis inducirebas axdenen da gaxangrZlivebuli moqmedebiT xasiaTdebian; ESAT-6daCFP-10rBCGpreklinikurma imunizaciam Tagvebi da gvineis goWebi xangrZlivad daicva diseminirebuli formebis ganviTarebisagan;

  15. AERAS-402/Crucell Ad35 busteria da adenovirus 35 veqtoriT iwvevs M. tuberculosis 85A, 85B, TB10.4 antigenebis eqspresias, rac TavisTavad CD+4 da CD+8 markeris mqone T limfocitebis inducirebas axdens; • AERAS-485/MVA85A busteria; virus ankara MVA 85 veqtoriT aRwevs makrofagis SigniT da iwvevs TCD+4 limfocitebis gaxangrZlivebul inducirebas; klinikuri kvlevebis I faza 2010 wlidan gaaqtiurdeba Seva (SATVI).

  16. Ag85 rBCG30 TB-s winaaRmdeg mzardi imuno proteqciiT xasiaTdeba. iwvevs specifiuri CD+4 da CD+8 markeris mqone limfocitebis inducirebas da ujredSida mikobaqteriis inhibirebas. masze preklinikuri kvlevebi dasrulebulia, dawyebulia klinikuri kvlevebi arainficirebul voluntarebze; • VPM 1002rBCG garda listeriolisinis eqspresiiT gamowveuli imunoproteqciisa (IFN-g) fagosomis mJava garemos neitralizacias axdens. is CarTulia klinikur kvlevebSi.

  17. cocxali peroraluri nukleokapsiduri TB vaqcina rdsRP ShigellaveqtoriT Shigella-rdsRP vector Induction of TB-specific CD4+ and CD8+ T cells Presentation of TB antigens in the context of HLA class I&II Invasion Nucleus EF2-independent translation of TB antigens • Access cytoplasm • Lysis due to asd • Release of rdsRP Amplification of mRNA encoding TB antigens by alphavirus amplicon Synthesis of recombinant segment-S mRNA by RNA-dependent RNA polymerase activity of rdsRP

  18. TBvaqcinebi, romlebzec mimdinareobs kvlevebi Pre-clinical Phase I Phase II Phase IIB Phase III Other rBCG rMtb AERASrBCG VPM 1002 rekombinantuli BCGs CvilebisaTvis virusiT veqtorirebuli vaqcinebi CvilebisTvis, mozardebisTvis da aivinficirebulebisaTvis. AERAS 402/ Crucell (2009) AdAg85A AERASOther Virus AERAS405 Capsid MVA85A/ AERAS 485 HyVac4/ AERAS 404 GSK M72 Other Protein PSS rekombinantuli cilovani SenaerTebi CvilebisTvis, mozardebisTvis, axalgazrdebisTvis da aivinficirebulebisaTvis. AERASPSS Hybrid 1 SSI April 2009

  19. gmadlobT yuradRebisaTvis

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