DynPort Vaccine Company LLC, A CSC Company, 64 Thomas Johnson Drive Frederick, MD 21702, USA. Email:
Int J Toxicol. 2013 Sep-Oct;32(5):327-35. doi: 10.1177/1091581813497405. Epub 2013 Aug 1.
A recombinant vaccine (rF1V) is being developed to protect adults 18 to 55 years of age from fatal pneumonic plague caused by aerosolized Yersinia pestis. A comprehensive series of studies was conducted to evaluate the general toxicity and local reactogenicity of the rF1V vaccine prior to first use in humans. Toxicity was evaluated in CD-1 mice vaccinated with control material and three dosage concentrations of rF1V with or without Alhydrogel(®) by intramuscular (IM) injection on Study Days 1, 29, 57 and 71 in a volume of 0.1 mL. Total immunizing protein given in each dose was 0, 20 or 60 μg/animal. Local reactogenicity was evaluated in mice at the dosages given and in New Zealand white (NZW) rabbits using the same injection volume and formulations (40, 80, 160 and 320 μg/mL total antigen and 0.3% (w/v) Alhydrogel(®)) intended for human use (0.5 mL). The rF1V vaccine produced no apparent systemic toxicity and only transient edema and erythema at the injection site. Together these results indicated a favorable safety profile for rF1V and supported its use in a Phase 1 clinical trial.
正在开发一种重组疫苗（rF1V），以保护 18 至 55 岁的成年人免受吸入性鼠疫耶尔森菌引起的致命性肺鼠疫。在首次用于人类之前，进行了一系列综合研究，以评估 rF1V 疫苗的一般毒性和局部反应原性。在研究第 1、29、57 和 71 天，通过肌肉内（IM）注射，用对照材料和三种 rF1V 剂量浓度（有或没有 Alhydrogel(®)）对 CD-1 小鼠进行毒性评估，注射体积为 0.1 毫升。每个剂量中给予的总免疫蛋白为 0、20 或 60μg/动物。在给予剂量的小鼠和新西兰白兔（NZW）中评估局部反应原性，使用相同的注射体积和制剂（40、80、160 和 320μg/mL 总抗原和 0.3%（w/v）Alhydrogel(®)），用于人类（0.5 毫升）。rF1V 疫苗未产生明显的全身毒性，仅在注射部位产生短暂的水肿和红斑。这些结果表明 rF1V 具有良好的安全性，支持其在 1 期临床试验中使用。
