Document Detail

Patient monitoring and follow-up in lentiviral clinical trials.
MedLine Citation:
PMID:  23322669     Owner:  NLM     Status:  Publisher    
BACKGROUND: Lentiviral vectors are being used with increasing frequency in human clinical trials. We were the first to use lentiviral vectors in clinical trials in 2003. Our lentiviral vector encoded a long RNA antisense sequence to the HIV-1 envelope and was used in an ex vivo autologous setting to provide viral load control in HIV-1 positive subjects and failing anti-HIV therapy. A total of 65 subjects have been treated in Phase 1 and Phase 2 trials in six institutions. METHODS: Good manufacturing practices (GMP) lots of the lentiviral vector used in our clinical trials were assayed for the presence of replication competent lentivirus (RCL). RCL assays were conducted at two stages. The first testing was performed on samples collected immediately following bulk harvest of the GMP product lot and consisted of 1x10(8) cells used in production. RCL assays were also performed on aliquots of the final fill of the vector by the inoculation of at least 5% of the GMP final fill volume into C8166 cells, passaged for at least 10 passages and tested for RCL by p24 ELISA and VSV-G envelope DNA. RESULTS: Following 263 infusions of autologous, transduced cells, no adverse events have been detected in these subjects, some followed for more than 8 years following infusions. More than 4.3 x 10(12) VRX496 proviral copies were administered to these 65 subjects. CONCLUSIONS: Data from this small population suggest there is no apparent risk for serious adverse events with the use of lentiviral vectors. Copyright © 2013 John Wiley & Sons, Ltd.
Gerard J McGarrity; Gloria Hoyah; April Winemiller; Kris Andre; David Stein; Gary Blick; Richard Greenberg; Clifford Kinder; Andrew Zolopa; Gwen Binder-Scholl; Pablo Tebas; Carl H June; Laurent M Humeau; Tessio Rebello
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-16
Journal Detail:
Title:  The journal of gene medicine     Volume:  -     ISSN:  1521-2254     ISO Abbreviation:  J Gene Med     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9815764     Medline TA:  J Gene Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2013 John Wiley & Sons, Ltd.
VIRxSYS, Corporation, Gaithersburg, MD, USA.
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