Viral & Rickettsial Diseases Department, Naval Medical Research Center, Silver Spring, MD, USA.
Hum Vaccin Immunother. 2012 Dec 1;8(12):1764-8. doi: 10.4161/hv.21806. Epub 2012 Oct 2.
A tetravalent DNA vaccine formulated with Vaxfectin adjuvant was shown to elicit high levels of neutralizing antibody against all four dengue virus serotypes (Porter et al., ( 16) ), warranting further testing in humans. In preparation for a phase 1 clinical testing, the vaccine and the adjuvant were manufactured under current good manufacturing practice guidelines. The formulated vaccine and the adjuvant were tested for safety and/or immunogenicity in New Zealand white rabbits using a repeat dose toxicology study. The formulated vaccine and the adjuvant were found to be well tolerated by the animals. Animals injected with formulated vaccine produced strong neutralizing antibody response to all four dengue serotypes.
一种用 Vaxfectin 佐剂配制的四价 DNA 疫苗被证明能诱导针对所有四种登革热病毒血清型的高水平中和抗体（Porter 等人，（16）），有必要在人类中进一步测试。为了准备进行 I 期临床测试，根据现行良好生产规范指南制造了疫苗和佐剂。使用重复剂量毒理学研究在新西兰白兔中测试了配制好的疫苗和佐剂的安全性和/或免疫原性。结果表明，该制剂对动物具有良好的耐受性。注射了配制好的疫苗的动物对所有四种登革热血清型均产生强烈的中和抗体反应。
