Columbia University

Technology Ventures

Bacterial Vaginosis Infections from Gardnerella Vaginalis Bacteria

Technology #2051

“Lead Inventor: Adam J. Ratner

STV Reference: IR 2051, IR 2345

Bacterial Vaginosis Treatments Carry High Rate of Side Effects and Recurrence Bacterial vaginosis is an infection of the female genital tract by Gardnerella vaginalis bacteria, often in combination with other bacterial species. It is the most common cause of vaginal discharge in women of childbearing years and is a risk factor for preterm birth and HIV acquisition. The current methodology for diagnosis of bacterial vaginosis, Nugent and Amsel criteria, relies on a combination of clinical evidence and microscopic examination of ”“clue cells”“ is laborious and requires trained technicians and pathologists. Emerging DNA probes for diagnosis of bacterial vaginosis have been shown to be less effective and more expensive.

On the therapeutic side, although metronidazole or clindamycin administered either orally or intravaginally result in a high clinical cure rate, oral medication is associated with a high rate of systemic side effects and antibiotics may also eliminate beneficial bacteria strains from the vaginal environment. Moreover, a high recurrence rate (30% within 3 months and more than 50% within 12 months) makes the disease persist and difficult to treat.

Cytolysin Protein Isolated for Diagnostic Testing Prevention and Recurrence A particular cytolysin, a class of protein responsible for targeting and lysing human cells, was found through a genome-wide search of Gardnerella vaginalis. The protein was cloned, isolated and shown to be especially specific for human cells.

Applications: • A new diagnostic test, more specific and potentially less laborious can be developed • New therapies can be developed based on antibody or inhibitor of the cytolysin • Vaccines for Gardnerella vaginalis can be developed • Cytolysin-negative Gardnerella vaginalis can have utility in prevention of recurrent disease

Advantages: • The cytolysin is specifically produced by Gardnerella vaginalis • The protein is especially specific for human red blood cells • A more specific antibody based diagnostic test can be developed based on the isolated protein • Antibody or inhibitor of the cytolysin can be developed as new non-antibiotic therapies for bacterial vaginosis

Through the generation of toxoid (non-lytic) strains and cytolysin-specific antibodies, vaccines for Gardnerella vaginalis can be developed

Opportunities: • Sponsored research funding for continuing on diagnostic tests, therapies and vaccine developments • Licensing

Patent Status: Patent Pending

Publications: J Bacteriol. 2008 Jun;190(11):3896-903. Epub 2008 Apr 4. Functional and phylogenetic characterization of Vaginolysin, the human-specific cytolysin from Gardnerella vaginalis. Gelber SE, Aguilar JL, Lewis KL, Ratner AJ.