Author: Lundstrom, Kenneth
Title: Alphavirus-Based Vaccines Document date: 2014_6_16
ID: 07iwwsfz_24
Snippet: Despite the large number of studies conducted in various animal models, relatively few evaluations have been subjected to humans. A clinical trial conducted with alphaviruses involved intravenous administration of liposome encapsulated SFV particles expressing IL-12 particles to melanoma and kidney carcinoma patients [95] . High transient expression of recombinant IL-12 with a five-fold increase lasted for 4-7 days. As higher doses induced a feve.....
Document: Despite the large number of studies conducted in various animal models, relatively few evaluations have been subjected to humans. A clinical trial conducted with alphaviruses involved intravenous administration of liposome encapsulated SFV particles expressing IL-12 particles to melanoma and kidney carcinoma patients [95] . High transient expression of recombinant IL-12 with a five-fold increase lasted for 4-7 days. As higher doses induced a fever response in patients, the maximum tolerated dose (MTD) was restricted to 3 × 10 9 encapsulated particles per m 2 . No liposome-or SFV-related toxicity was observed. Furthermore, the liposome-encapsulation prevented SFV particles from being recognized by the host immune system and, therefore, allowed repeated systemic administration. The phase I study clearly demonstrated the safe administration of encapsulated SFV particles.
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