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Vaccine. 2007 Oct 16;25(42):7441-9. Epub 2007 Aug 30.

Development and preclinical evaluation of an alphavirus replicon particle vaccine for cytomegalovirus.

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1
AlphaVax Inc., Research Triangle Park, NC 27709, USA.

Abstract

We used a replication-incompetent, single-cycle, alphavirus replicon vector system to produce virus-like replicon particles (VRP) expressing the extracellular domain of human cytomegalovirus (CMV) glycoprotein B or a pp65/IE1 fusion protein. Efficient production methods were scaled to produce pilot lots and clinical lots of each alphavirus replicon vaccine component. The vaccine induced high-titered antibody responses in mice and rabbits, as measured by ELISA and CMV neutralization assays, and robust T-cell responses in mice, as measured by IFN-gamma ELISPOT assay. A toxicity study in rabbits showed no adverse effects in any toxicology parameter. These studies support clinical testing of this novel CMV alphavirus replicon vaccine in humans.

PMID:
17870214
PMCID:
PMC2744093
DOI:
10.1016/j.vaccine.2007.08.016
[Indexed for MEDLINE]
Free PMC Article
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