THERAPYX, INC. — Department of Health and Human Services SBIR Phase I: NIAID

Description

DESCRIPTION provided by applicant Genital tract infection with Neisseria gonorrhoeae gonorrhea does not induce a state of specific protective immunity and can be acquired repeatedly Despite public health measures the disease persists at an unacceptably high frequency and resistance even to the latest generations of antibiotics continues to emerge There is no vaccine available and none appears to be on the horizon of development It has recently been demonstrated that N gonorrhoeae 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 it However this induced immunosuppression can be reversed by intravaginal treatment with the cytokine interleukin encapsulated in sustained release microspheres IL ms a proprietary product developed by TherapyX Inc to elicit effective immune responses against existing infection with N gonorrhoeae and thereby promote therapeutic clearance of the infection In this SBIR application a novel experimental gonococcal vaccine will be evaluated in a mouse model of vaginal gonococcal infection that is accepted as the only currently available animal model Phase I aims to establish Proof of Principle that a vaccine consisting of gonococcal outer membrane vesicles plus IL ms given intravaginally can induce protective immunity against genital gonococcal infection and generate recallable T cell and antibody responses to N gonorrhoeae The duration of immunity and protection against different strains of N gonorrhoeae will be determined Successful completion of Phase I will lead to Phase II in which the vaccine components dosage and immunization regimen will be optimized cross protection and long term efficacy against a diversity of naturally occurring strains of N gonorrhoeae and toxicity will be evaluated in preparation for clinical trial PUBLIC HEALTH RELEVANCE Gonorrhea is the second most frequent notifiable infectious disease in the United States the Centers for Disease Control report andgt cases annually and world wide incidence is estimated at over million new infections per year The emergence of multiple drug resistant strains of Neisseria gonorrhoeae now raises serious concerns over future treatment options and both US and international authorities have called for renewed efforts at vaccine development This proposal seeks to develop a vaccine against gonorrhea based on intravaginal immunization with gonococcal antigen plus a proprietary microencapsulated adjuvant which counteracts the ability of N gonorrhoeae to interfere with the normal course of an immune response