ORAL DISPERSIBLE VACCINE COMPRISING VIROSOMES

The present disclosure is directed to oral vaccine dosage forms and processes for producing the oral vaccine dosage forms. The dosage forms include lipid-based vesicles (e.g., virosomes, liposomes) harboring an immunogenic amount of at least one vaccinal target molecule, with or without adjuvant. Specifically, Applicants discovered a combination of the composition of the liquid virosome concentrates, the composition of the base matrix for the solid dosage form formulation (excluding the virosome concentrate), and the manufacturing conditions for the dosage forms that can produce a freeze dried sublingual dosage form having physical robustness, particle and antigen integrity and stability. 本公开内容涉及经口疫苗剂型和用于生产经口疫苗剂型的方法。剂型包括基于脂质的囊泡(例如病毒体、脂质体)，其具有免疫原性量的至少一种疫苗靶分子，连同或不连同佐剂。具体地，申请人发现了液体病毒体浓缩物的组合物、用于固体剂型制剂的基础基质的组合物(排除病毒体浓缩物)、以及用于剂型的制造条件的组合，所述剂型可以产生具有物理稳固性、颗粒和抗原完整性和稳定性的冷冻干燥的舌下剂型。