VAGINAL IMMUNIZATION AGAINST URINARY TRACT INFECTIONS

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Recurrent bacterial urinary tract infections (rUTI) are among the most common infectious diseases and cause of morbidity in women. An alternative to the current antibiotic treatment and prophylaxis is the use of vaccines to immunize against this disease. An injectable vaccine for rUTI has been developed and marketed abroad but was withdrawn because of significant undesirable systemic effects. When this vaccine was administered by Protein Express' novel intravaginal suppository system, it was very well tolerated and resulted in a significant delay in UTI recurrence. Current clinical investigations seek to further demonstrate utility of this vaccine as a safe and effective method of mucosal immunization. In efforts to continue these investigations, Protein Express has acquired the exclusive rights for the production of this vaccine. We now seek to meet the needs of extending these and future clinical studies, meet GMP requirements essential to allow FDA acceptance for production, and provide stability data for this vaccine. Definitive Phase Il studies can then be designed to meet the commercial goal of a well-tolerated, cost-effective medication for the clinical control of rUTI. PROPOSED COMMERCIAL APPLICATIONS: The underlying problem, recurrent urinary tract infection, is a serious medical concern, as indicated in a recent NIH Program Announcement (PA 97-073, "Mucosal immunity in pathogenesis/prevention of human disease"). The vaccine suppository described herein should be quickly useful in helping the estimated 7 million women annually affected by enteric urinary tract infection. Further development may also show utility in protecting against other genitourinary infections.