brazilian platform vaccine against covid-19 a vlp … · santuza teixeira ana paula fernandes...
TRANSCRIPT
Dialogues template | XX.2019 1
BRAZILIAN PLATFORM – VACCINE AGAINST COVID-19
A VLP VACCINE AND
A BIVALENT VACCINE FOR INFLUENZA AND COVID19
LOGO OF YOURSPONSOR
OBJECTIVES
To generate a virus-like particle containing neutralizing and T cell epitopes derived from SARS CoV2
To generate a recombinant influenza expressing spike protein from SARS CoV2 and seasonal H1
Immunogenicity and protection tests in animal models
Safety tests in animal models
Scale-up
Clinical trials 1/2/3
Industrial production and distribution
CONSORTIUM COMPOSITION
UNIVERSIDADE FEDERAL DE
MINAS GERAIS
(UFMG)
UNIVERSIDADE DE SAO PAULO
USP
INSTITUTO BUTANTAN
(IB)
FUNDAÇAO OSWALDO
CRUZ
(FIOCRUZ)
USP, FIOCRUZ/UFMG -> generation of VLPs and recombinant influenza;USP and Fiocruz -> animal models and clinical trials;IB and BIO -> scaling-up and production of influenza and VLP vaccines, respectively
UNIVERSIDADE FEDERAL DE SÃO PAULO
(UNIFESP)
FUNDAÇAO OSWALDO
CRUZ
(FIOCRUZ)
BIO
MANGUNHOS
(BIO)
UNIVERSIDADE DE SAO PAULO
(USP)
VLPs Project Influenza Project
Fiocruz
Dialogues template | XX.2019 4
METHODOLOGY:
FUNDING:
HEK293T NA_SV2
H1/H3
MDCKCCL34
M2
Recombinant Influenza
Clinical Phases• Safety• Immunological
Response • Antibody
productionTechnology
transfer for large-escale production
- In vitro - Pre-clinical- Clinical Trial
• Celular proliferation
• Neutralizationcapacity
Pre-clinicaltests
• Immunogenicity• Toxicity• Protection
BAlb/c mice andknockin para ACE-2
VLP expression
Peptides Microarray
Chip design a partir da proteína
Spike
HLA
Production of VLPs andconjugation of T and B
selected epitopes
Synthesis ofselectedpeptides
• Monoclonal antibodies
• Screening of T-cell epitopes
Blood from Covid19 covalescents
Serum
PBMC
DNA
VLP Strategy
METHODOLOGYSTEP 3STEP 2STEP 1 STEP 4
Testing 200 samples for epitopes (VLP) and
Engineering prototypes (both)
Validation
Immunogenicity tests in mice
STEP 5
Proof of conceptin ACE2
Transgenic mice
Safety tests in rodent and
rabbits
STEP 7
Scale-up
STEP 8
Phase 1/ 2a safety and
immunogenicity
STEP 6
Phase 3 clinical trial
STEP 9
LicensingIndustrial
production anddistribution08/2020
09/2020
12/2020
02/2021
04/2021
10/2021
2022
05/2020
Dialogues template | XX.2019 7
PRODUCT:
FUNDING:
H1
RBD
RBD
A)
Fonte:virology.ws
B)
C)
HA
NA
A)
Hybridgeneneuraminidase/Spike
SARS-CoV2Non-replicativeInfluenza
RecombinantInfluenzaSpikeVirus
Spike
Neuraminidase
SARS-CoV2RBD
Hemaglutinin(H1)
Influenza-COVID-19
Virus Like Particles
EXPECTED RESULTS Two COVID-19 vaccine prototypes: VLP- and Influenza-based
Vaccines that induce neutralizing antibodies and specific T cells
Safety tests in rodent and rabbit
Scale-up
Dose scalation, safety and immunogenicity tests in humans
(Phase 1 and 2a)
Immunogenicity tests and protection (Phase 3)
Industrial production and distribution
SUGGESTIONS FOR FUTURE COLLABORATION
Fast delivery of crucial supplies and biological tools
Manufacture technology
Confirmation of safety tests in animals
Multi-centre phase III Clinical trials
Dialogues template | XX.2019 10
FUNDING and Collaborators:
FUNDING:
Fiocruz
Alexandre Machado
Ricardo Gazzinelli
Instituto Butantan
Viviane Botosso
Ricardo Palazzo
USP
Jorge Kalil
Edecio Cunha Neto
Gustavo Cabral Miranda
Keity Souza Santos
Silvia Boscardin
Edson Durigon
Paolo Zanotto
UNIFESP
Daniela Rosa
Juliana Apostolico
UFMG
Santuza Teixeira
Ana Paula Fernandes
Flávio da Fonseca
Diálogos template | XX.2019 11
THANK YOU