Post on 22-Aug-2020
Vaccine Development in ThailandPrasert Auewarakul
Prof. Dr. Prasert Auewarakul Deputy Dean for Research
Re f. h ttp ://www.s i.ma hid o l.a c .th/a nnua lre p ort/2016/file s /180.p d f
732, 82%
161, 18%
Ac a d e mic S ta ff
c lin ic
p re -c lin ic
Tota l 893
Tota l Be d s
2 ,071> 3 millions pa tie nt vis its /ye a r
• Tota l public a tion = 3483 pa pe r• Corre s ponde nc e = 1716 (49.27%)
• Clinic = 1319 (76.86%)• Pre -c lin ic = 397 (23.14%)
Pub lic a tions 2016-2019
659 639 560
873955
885 853
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200
400
600
800
1000
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2013 2014 2015 2016 2017 2018 2019(9m)
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Pub lic a tions 2013-2019 (Da ta from ISI We b of s c ie nc e , Sc op us & Pub Me d)
Sir ira j Ins titu te of Clin ic a l Re s e a rc h (SICRES)CHARACTERISTICS
Academic Clinical Research Organization
International Standard
Research Network Capacity
Publications and Implications
Effective Research Management: Flexibility, Autonomy, Professional
Grant Application by local Investigators
Generator of new investigators
AIM
Full-service clinical trial management
Integrated Database and Analysis
Be s t Clin ic a l Re s e a rc h Ce nte r Awa rd 2017 a nd
2018
by
Tha ila nd Towa rd Exc e lle nc e in Clin ic a l
Tr ia ls (Tha iTECT)
Tra ns forming from SiCRC to SICRES
SICRES Fa c ility for BE a nd Pha s e 1
SICRES Fa c ility for BE a nd Pha s e 1, 28 b e d s
SICRES Fa c ility for BE a nd Pha s e 1
CLEANROOM ISO c la s s 5 for Ce ll the ra pySr is a va r ind ira Build ing 10th Floor
▰We ll ma inte na nc e a nd p e rforma nc e to e ns ure h ig h-q ua lity la b ora tory
▰Provid e re s e a rch fa c ility s e rvic e to p romote Adva nc e d The ra py Me d ic ina l Prod uc t
▰Inve s tiga tors mus t ob ta in IRB a p p rova l a nd GMP c e r tific a te
CLEANROOM ISO c la s s 7 for Ge ne the ra pySiMR Build ing 8 th Floor
SIRIRAJ LABORATORY FOR ANIMAL RESEARCH AND CARE CENTER
• Provide la bora tory a nima l c a r ing s e rvic e for re s e a rc h a nd a c a de mic purpos e s
• Cons is t of 4 Anima l rooms• Supp ly la bora tory a nima ls ; mic e a nd ra ts
Dengue
• In 1980, Mahidol University committed to develop a live-attenuated tetravalent DENV vaccine. The DENV vaccine development project was supported by a grant from the WHO Regional Office for South-East Asia.
• The vaccine candidates were further developed into clinical trials by Sanofi-Pasteur, but the development was not successful because one serotype was under-attenuated.
• The attenuation mutations of Dengue 2 candidate were mapped in collaboration with US CDC. The mutation set is called PDK53.
• The PDK53 has been used as the core technology for Takeda vaccine candidates.
• A second set of cell culture-adapted vaccine candidates have been licensed to Kaketsuken and has shown good profiles in a phase I clinical trial.
1980 2015
Mahidol 1 :Serial passageslive attenuated vaccine
2008
NSTDA1 & 2:Chimericlive attenuated vaccine
TDNA:Human codon optimized DNA vaccine
2009
TVLP : C6/36
2010
Mahidol 2 :Serial passageslive attenuated vaccine
TVLP : S2/ SF9/mammalian cells/ eggs
2017
TE80 : S2
Dengue vaccine development in Thailand
https://mb.mahidol.ac.th/en/center-for-vaccine-development/
Controlled human infection model (CHIM)
CHIM for Dengue• Dengue human infection model was first studies in 1902.• It has recently regained interest.• WRAIR: Development of CHIM with symptomatic dengue
fever. WRAIR has evaluated seven viruses and has identified two (Dengue 1 and 3) that meet dengue fever criteria.
• US NIH and Johns Kopkins: DEN2∆30. This virus induced low level of viremia in 100% of subjects without causing severe clinical signs and symptoms.
Conclusions• In Thailand, there have been vaccine development activities
ranging from upstream discovery to production and clinical trials. • Mahidol University is among the top institutions in Thailand
actively pursuing vaccine development.