Phase I clinical trial of vaginal mucosal immunization for recurrent urinary tract infection.

ABSTRACT

In a phase I clinical trial to test safety and patient acceptance 25 women with a history of recurrent urinary tract infections but no identifiable anatomic abnormality received a multivalent vaccine instilled into the vagina. The vaccine contained 6 heat-killed Escherichia coli strains and 4 nonE. coli uropathogens. Only minimal adverse reactions were observed in the 5-month period following immunization. Total vaginal and urinary IgG and IgA increased significantly (p < 0.01 by repeated measures analysis of variance). Serum antibodies to some of the nonE. coli strains but not to the E. coli strains increased after vaginal immunization. While efficacy is yet to be shown, this study indicates that this vaginally applied urinary tract infection vaccine is well tolerated, and capable of increasing vaginal and urinary antibody.