Vaccine Development in ThailandPrasert Auewarakul

Prof. Dr. Prasert Auewarakul Deputy Dean for Research

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• Clinic = 1319 (76.86%)• Pre -c lin ic = 397 (23.14%)

Pub lic a tions 2016-2019

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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/

https://www.tm.mahidol.ac.th/vtc/

Controlled human infection model (CHIM)

https://www.tm.mahidol.ac.th/vivax/

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.