期刊
VACCINE
卷 25, 期 42, 页码 7441-7449出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2007.08.016
关键词
cytomegalovirus vaccine; manufacturing process; cellular immunity; toxicology testing
资金
- NIAID NIH HHS [R43 AI060060-01, R4 AI060060, R43 AI060060, R43 AI060060-02] Funding Source: Medline
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. (D 2007 Elsevier Ltd. All rights reserved.
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