Virosomal C. albicans vaccine for vaginal application: formulation development and toxicity/immunogenicity studies

This study describes the preclinical development of a virosomal vaccine against recurrent vulvovaginal candidiasis, specifically designed for vaginal administration. The vaccine antigen is a recombinant, truncated form of the C. albicans virulence factor secreted aspartyl protease 2, which is displayed on the surface of influenza virosomes. The final product, PEV7A, consists of the lyophilized vaccine blended with optimized excipients, and filled into HPMC capsules, suitable for vaginal application and reconstitution in vivo. The encapsulated vaccine was characterized and tested in combined toxicology/immunogenicity studies in two species, minipigs and rabbits. The vaccine was shown to be safe and well tolerated, and it induced specific antibody responses in both species.