Nonclinical biodistribution, integration, and toxicology evaluations of an H5N1 pandemic influenza plasmid DNA vaccine formulated with Vaxfectin®.
Vaccine
; 29(33): 5443-52, 2011 Jul 26.
Article
em En
| MEDLINE
| ID: mdl-21641955
ABSTRACT
Vaxfectin(®) is a lipid-based adjuvant initially developed for use with plasmid DNA (pDNA) vaccines. Here we present detailed nonclinical assessments performed prior to Vaxfectin(®)'s first-in-man use, as an adjuvant in the H5N1 influenza vaccine VCL-IPT1. Following IM delivery to rabbits, VCL-IPT1 pDNA localized primarily to injection sites, where levels steadily declined over the 2 months examined. Risk of pDNA integration into genomic DNA was negligible. Toxicology studies in rabbits revealed mild inflammatory/immune responses at injection sites characteristic of IM vaccine delivery; Vaxfectin(®) directly contributed to these responses. These data support clinical development of H5N1 pDNA vaccines, and also present an encouraging profile for further development of Vaxfectin(®) as an adjuvant for vaccines in general.
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1
Base de dados:
MEDLINE
Assunto principal:
Fosfatidiletanolaminas
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Vacinas contra Influenza
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Adjuvantes Imunológicos
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Vacinas de DNA
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Virus da Influenza A Subtipo H5N1
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article