Treatment and prevention of
The present invention is drawn to the nucleic and amino acid sequences encoding vaginolysin (VLY) toxin from Gardnerella vaginalis , and biologically active fragments and variants thereof. The invention is also directed to anti-VLY antibodies and to their use therapeutically and in a new ELISA assay of VLY toxin. Other embodiments of the invention are directed to VLY toxoids and to vaccines that use the new VLY toxoids as immunogens.
1. A method for diagnosing and treating a G. vaginalis infection or bacterial vaginosis in a patient, comprising:
a. obtaining a biological sample from the patient,
b. detecting the presence of vaginolysin protein having the amino acid sequence set forth in SEQ ID NO: 2 or SEQ ID NO: 11, or an immunogenic fragment thereof in the biological sample using a sandwich ELISA assay in which soluble CD59 is used as a capture agent and one of an anti-vaginolysin antibody including poly anti-vaginolysin, anti-pneumolysin antibody, monoclonal anti-vaginolysin and anti-intermedialysin is used as a detection antibody,
c. and if the respective protein is detected then administering to the patient a therapeutically effective amount of an antibiotic that is selected from the group consisting of metronidazole, clindamycin, and tinidazole, or a protective agent that is a member selected from the group consisting of anti-vaginolysin antibody, anti-pneumolysin antibody, anti-CD59 antibody, soluble CD59, G. vaginalis vaginolysin toxoid, or an immunogenic fragment thereof.