Experimental Gonococcal Vaccine

ABSTRACT Genital tract infection with Neisseria gonorrhoeaegonorrheadoes not induce a state of specific protective immunity and it can be acquired repeatedlyDespite public health measuresthe disease persists at an unacceptably high frequencythere is no vaccine against itand resistance even to the latest generations of antibiotics continues to emergeRecent findings have revealed that Ngonorrhoeae subverts the immune system for its own benefit by eliciting innate responses that it can survive and by suppressing specific adaptive responses that would eliminate itHoweverthis induced immunosuppression can be reversed by treatments that effectively redirect the immune response against NgonorrhoeaeProof of principle has been established for a novel strategy of prophylaxis against genital gonococcal infection using a mouse model that is accepted as the only currently available animal modelThe current vaccine prototypeGvaXa combinatorial formulation of our proprietary sustained release nanoparticulate interleukinand gonococcal outer membrane vesiclesinduces anti gonococcal T cell and antibody responsesand generates protection against homologous and heterologous strains for up tomonthsIn this Phase II applicationwe will defineoptimizeand validate a vaccination regimen including routeaiming for intranasal administrationWe will determine the basis of cross protection against diverse strains of naturally occurring Ngonorrhoeaeand begin preliminary pharmacokinetics and toxicology studies in preparation for subsequent toxicological testing in nonhuman primatesAlong with the preclinical datatoxicology results and future plans will be incorporated into a briefing package that will be submitted to the FDA in a request for a Type C Meeting