EFFICACY OF E. COLI PILUS VACCINE FOR URINARY INFECTION

URINARY TRACT INFECTIONS (UTI) CONSTITUTE A SERIOUS HEALTH PROBLEM FOR VARIOUS COMMUNITY AND HOSPITALIZED POPULATIONS. IT IS ESTIMATED THAT AS MANY AS 50% OF ALL WOMEN WILL EXPERIENCE AT LEAST ONE UTI DURING THEIR LIFETIME. TECHNOLOGICAL ADVANCES IN BACTERIAL PILUS RESEARCH AT PROVAC, INC., HAVE LED TO THE DEVELOPMENT OF AN ESCHERICHIA COLI MULTIVALENT PILUS VACCINE WITH A PRIMARY INDICATION FOR UTI. THE LONG-TERM OBJECTIVE IS TO EVALUATE THE SAFETY AND EFFICACY OF THE VACCINE IN HUMAN CLINICAL TRIALS. PRECLINICAL STUDIES, IN AN EXPERIMENTAL UTI MURINE MODEL UNDER DEVELOPMENT, HAVE SUPPORTED THE POSITIVE EFFECT OF IMMUNIZATION AGAINST HOMOLOGOUS CHALLENGES WITH UNIVALENT PILUS VACCINES. THE IMMEDIATE AIM IS TO DEMONSTRATE HETEROLOGOUS PROTECTION WITH A MULTIVALENT PURIFIED-PILUS VACCINE IN A MURINE MODEL WHEN CHALLENGED WITH HUMAN CLINICAL ISOLATES EXPRESSING THE PREVALENT PILUS TYPES, TYPE1 AND P PILI. THE DURATION OF THE ANTIBODY RESPONSE WILL ALSO BE MONITORED BOTH LOCALLY AND SYSTEMICALLY. THESE EXPERIMENTS SHOULD PROVIDE THE FIRST SUPPORTIVE EVIDENCE THAT A MULTIPLE-PILUS VACCINE CAN BE EFFICACIOUS FOR UTI BEFORE EXTENSIVE HUMAN CLINICAL TESTING BEGINS.