Desafios para o desenvolvimento de uma vacina para o Zikavírus. development of a vaccine for Zika virus
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1 Desafios para o desenvolvimento de uma vacina para o Zikavírus Challenges for the development of a vaccine for Zika virus Elena Caride Viral Vaccine Program R&D Vice-Directory Bio-Manguinhos/Fiocruz Rio de Janeiro
2 Flavivirus Vaccines Most neutralizing antibodies are induced against E protein, and all approved and most developing flavivirusvaccines contain E antigens
3 Flavivirus Infections in Humans Mosquitoes-transmittedviruses: YellowFever, Dengue Fever, Japaneseencephalitis, West Nileviruses, St. Louis encephalitis Zikavirus Flavivirusestransmittedbyticks: Tick-borne Encephalitis(TBE), KyasanurForest Disease(KFD) Alkhurmadisease, Omsk hemorrhagic fever
4 Worldwide distribution of flaviviruses Adapted form T. Ishikawa et al. / Vaccine 32 (2014)
5 FlavivirusesVaccines Adapted form T. Ishikawa et al. / Vaccine 32 (2014)
6 Flavivirus Vaccines Flavivirusvaccines against YFV, JEV TBEV and DENV infections have been developed using different platforms.
7 FlavivirusVaccines Disease Vaccine type Strain Substrate Adjuvant YFV JEV TBE DENV Live attenuated vaccine (βpropiolactone) vaccine Live attenuated vaccine Live-attenuated chimeric vaccine Live-attenuated chimeric vaccine 17DD and 17D D-204 Nakayama Beijing-1 (P1) Beijing-1 (P3) SA SPF embryonated chicken eggs Vero cell (bioreactors) Mouse brain Primary hamster kidney cell (PHK) Primary hamster kidney cell (PHK) no Alum SA Vero cell Alum Beijing-1 Vero cell Alum SA prm/e genes replaced YFV-17D genes Neudorf (TBEV-Eu) Sofjin (TBEV-Fe) German K23 (TBEV- Eu) 205 (TBEV-Fe) DENV 1, 2, 3 and 4 prm/e genes replaced YFV-17D genes Vero cell Primary chicken embryo cell (PCEC) Primary chicken embryo cell (PCEC) Primary chicken embryo cell (PCEC) Primary chicken embryo cell (PCEC) Vero cell no no no no Immunization schedule One dose, 10 years Two doses, 4wks apart Two doses, 4wks apart Two doses, 1wk apart One dose Booster 7 yrs Two doses, 4wks apart Two doses, 4wks apart Single dose Booster dose have not yet been determined Manufacturer(s) Brazil (Bio-Manguinhos/Fiocruz); France (Sanofi Pasteur); Senegal (The Institute Pasteur in Dakar); Russia (Chumakov Institute of Poliomyelitis and Viral Encephalitis) Xcellerex/GE HealthCare (US) Phase 1 Green Cross (South Korea), Central Research Institute (India), Adimmune corp (Taiwan), Government Pharmaceutical Organization (Thailand), Vabiotech (Vietnam) Beijing, Shanghai, Wuhan and Changchun Institute of Biological Products (China) Status Licensed in 1937 Licensed in 1930 Licensed in 1968 Chengdu Institute of Biological Product (China) Licensed since 1988 Valneva SE (France) Biological E (India) Biken (Japan) Sanofi Pasteur (France) Licensed since 2009 WHO prequalified Licensed in Japan since 2009 Licensed in Australia and Thailand since 2010 Alum Three doses Baxter AG, Austria Licensed since 1976 Alum Three doses Chumakov Institute of Poliomyelitis and Viral Encephalitides, Russia Licensed since 1982 Alum Three doses Novartis, Switzerland Licensed since 1991 Alum Three doses Microgen, Russia Licensed since 2001 no Three doses six months apart Sanofi Pasteur Licensed since 2015
8 Bio-Manguinhos
9 Vaccine development activities Hardt et al., Vaccines 2013, 1(3), ;
10 Candidate selection Antigen delivery platform definition Upstream process definition Downstream process definition Seed lots preparation Pilot scale up
11 Pre-Clinical and Clinical Phases Prelicensure Postlicensure Animal models Animal studies - Proof of Concept Animal QC Phase 1 Clinical Trial Phase 2 Clinical Trial Phase 3 Clinical Trial Phase 4 Clinical Trial Disease models Challenge models LD50 Viremia RNAemia Immunogenic ity Protection Dose ranging Immunity Humoral Cell mediated Memory Safety Correlates of protection Toxicology Potency Safety Safety Immunogenicity dose ranging Safety Immunogenicity Efficacy Immunogenicity Pharmacovigilance
12 Use insect repellents! Thank you!
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Published on Horizon 2020 (https://ec.europa.eu/programmes/horizon2020) Tuesday, 13 January, 2015 [1] An EU-funded project s state-of-the-art approach could accelerate the discovery of new antiviral drugs