Viral Shedding Viral Shedding <in hospital> <in - - PowerPoint PPT Presentation
ICH WORKSHOP: Viral Shedding Review of experience of shedding data for in vivo gene therapy Teruhide YAMAGUCHI Viral Shedding Viral Shedding <in hospital> <in hospital> into Patients' ??? ??? Blood, Urine, Gene Therapy
Gene Therapy Products Gene Therapy Products
patients patients
Viral Shedding into Patients' Blood, Urine, Feces, Sputum... <in hospital> <in hospital> <into the environment > <into the environment > ??? ??? ??? ??? ??? ???
– Depends on biodistribution and the biological activity of each vector – Depends on the route of administration, dose and so on
– biological activity of virus shed – viability of virus in the environment
Ｖ Ｖ Adeno Adeno-
Associated virus virus Adenovirus Adenovirus Should all Viral Vectors be treated in the same way in relation to shedding? Review of experience of shedding data for Review of experience of shedding data for in vivo in vivo gene therapy gene therapy
Impact of Impact of viral shedding is dependent on: viral shedding is dependent on:
Property of virus
Biodistribution
Route of administration
Systemic or local administration
Ex vivo or not
Dose
High or low
Single dose or repeat doses
Seneca Valley virus ( Seneca Valley virus (Picornavirus Picornavirus) )
Detection of viral shedding Detection of viral shedding Detection of viral shedding
PCR PCR PCR
sensitive and accurate sensitive and accurate sensitive and accurate
no correlation of infectivity no correlation of infectivity no correlation of infectivity
Infectivity assay Infectivity assay Infectivity assay
less sensitive less sensitive less sensitive
New method New method New method
Infectivity PCR Infectivity PCR Infectivity PCR
sputum sputum sputum sputum Blood Blood Blood Blood
How long viral shedding is How long viral shedding is How long viral shedding is detected detected detected detected
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