FDA guidance on prophylactic DNA vaccines: analysis and recommendations.

Vaccine
Dennis M KlinmanFolkert Steinhagen

Abstract

The FDA has been regulating the conduct of prophylactic DNA vaccine trials in the US for nearly 15 years. This work describes the evolution of FDA policy over that period, the status of current regulatory guidance, and provides recommendations for further changes to facilitate development in this field.

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Citations

Mar 13, 2014·Vaccine·Peter Stephens
Aug 15, 2012·Microbial Cell Factories·Diana M Bower, Kristala L J Prather
Feb 9, 2012·Expert Review of Vaccines·Fadi Saade, Nikolai Petrovsky
Apr 22, 2011·Expert Review of Vaccines·Christian BodeDennis M Klinman
Jul 18, 2015·Journal of Controlled Release : Official Journal of the Controlled Release Society·Vítor M GasparIlídio J Correia
Dec 1, 2015·Human Vaccines & Immunotherapeutics·Vincent Le MoigneJean-Louis Herrmann
Jan 10, 2014·Human Vaccines & Immunotherapeutics·Roger H BrookesNausheen Rahman
Jan 20, 2011·Molecular Therapy : the Journal of the American Society of Gene Therapy·Shashi A GujarPatrick W K Lee
Jul 3, 2019·Expert Review of Vaccines·Claudia Maria TrombettaEmanuele Montomoli
May 28, 2014·Human Vaccines & Immunotherapeutics·Nathalie BöhlesMichael Hensel
Dec 4, 2019·Expert Review of Vaccines·Iván Del Moral-Sánchez, Kwinten Sliepen
Oct 10, 2014·Oncotarget·Vladimir GabaiAlexander Shneider
Sep 14, 2018·BioImpacts : BI·Sepideh ParvizpourYadollah Omidi
Jun 22, 2021·Expert Review of Vaccines·Velasco CimicaTimothy T Stedman

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