Infante-Bourzac Juan Francisco, Sifontes-Rodríguez Sergio, Arencibia-Arrebola Daniel Francisco, Hernández-Salazar Tamara, Fariñas-Medina Mildrey, Pérez Oliver
Department of Animal Model and Immunology, Vice Presidency of Research, Finlay Institute, Havana, Cuba.
N Am J Med Sci. 2012 Mar;4(3):135-40. doi: 10.4103/1947-2714.93888.
The AFCo1 cochleate is a potential novel adjuvant derived from Neisseria meningitidis B proteoliposome.
The aim was to assessing the safety of AFCo1 by single and repeated doses in Sprague Dawley rats.
Rats were grouped for treatment with AFCo1, placebo formulation or control. The first study was a single intranasal dose of 100 μl and monitoring body weight, water, and food intakes as well as clinical symptoms. Fourteen days later the rats were killed and anatomopathological studies were conducted. In a second study, four similar doses of the test substance were instilled every 5 days. Clinical observations were carried out as for the single dose study and a number of rats from each group were killed 3 and 14 days after the last dose in order to conduct hematological, hemochemical, and anatomopathological studies.
No variable showed differences of toxicological relevance; the histological changes found were mild and similarly frequently in the three groups. According to the irritability index calculated form histology of the nasal region, AFCo1 was also classified as nonirritating.
AFCo1 is potentially safe for human use by nasal route as evidenced by the absence of local and systemic signs of toxicity in Sprague Dawley rats.
AFCo1 耳蜗状脂质体是一种源自 B 型脑膜炎奈瑟菌蛋白脂质体的潜在新型佐剂。
旨在评估 AFCo1 在 Sprague Dawley 大鼠中单次和重复给药的安全性。
将大鼠分组，分别用 AFCo1、安慰剂制剂或对照进行处理。第一项研究是单次经鼻给予 100 μl，并监测体重、水和食物摄入量以及临床症状。14 天后处死大鼠并进行解剖病理学研究。在第二项研究中，每 5 天滴注 4 次相似剂量的受试物质。如同单次剂量研究一样进行临床观察，在最后一次给药后 3 天和 14 天，每组处死若干只大鼠，以便进行血液学、血液化学和解剖病理学研究。
未发现具有毒理学相关性差异的变量；所发现的组织学变化轻微，且在三组中出现频率相似。根据鼻腔区域组织学计算的刺激指数，AFCo1 也被归类为无刺激性。
在 Sprague Dawley 大鼠中未出现局部和全身毒性迹象，证明 AFCo1 通过鼻腔途径用于人体可能是安全的。
