Evaluación de la irritabilidad en mucosa del adyuvante AFCO1 por el método de HET-CAM

adjuvants can cause local irritation of the mucosa and this might be a limitation for their clinical use. in order to evaluate if afco1, a novel intranasal adjuvant based on a proteoliposome-derived cochleate structure from neisseria meningitidis b, produces mucosal irritation, the direct effect after its application on the chorioallantoic membrane (cam) of hen's eggs was studied using het-cam (hen's egg test on chorioallantoic membrane), according to protocol 47 of invittox, an in vitro validated method that substitutes the classic draize′s test in rabbits. three 10-days-old eggs were used for each evaluated product (afco1 or pbs as vehicle) and two eggs for each positive control of irritation (naoh a 0.1 n y sds at 1%). the products were applied on the cam to evaluate the grade of lyses, haemorrhage and coagulation, at five minutes. the products were classified according to an established scale for non transparent substances. additionally, a microscopic evaluation was carried out to confirm previous results. when determining the severity degree of the three reactions after the application of afco1 and the diluent, they show to be non irritant, what demonstrates that this cochleate does not produce direct epithelial damage. our results also reveal the utility of het-cam as tool for the evaluation of mucosal irritation of vaccine adjuvants.