Manufactured in accordance with the current GMP standards, the therapeutic vaccine is based on a blend of inactivated lactobacilli strains.
The primary endpoint of the double-blind and placebo-controlled trial includes the treatment of BV confirmed by the Nugent scoring system.
Conducted at five clinical centers in Hungary, the trial will recruit 240 patients and will examine changes in vaginal mucosa as well as assess several immunological markers.
The Swiss-based biotech company is planning to include the first patient this month and to complete patient enrollment within about nine months.
AmVac CEO Melinda Karpati said based on past clinical evidence and recently discovered mechanisms of action of Gynevac, the company believes that the vaccine will change the lives of millions of patients suffering from various abnormalities – including BV and BV related premature delivery in women and possibly chronic prostatitis associated benign prostatic hyperplasia in men.
"This confirmatory study is an important milestone in our strategy to leverage the vaccine’s full potential and bring it to patients around the world who currently have limited treatment options," Karpati added.
Approved in Hungary in 1997 for the treatment of certain gynecological inflammations, the previous version, containing Thiomersal, has been used to treat over 200,000 patients suffering from various urogenital conditions.
BV is among the most common conditions found in women health care settings with an estimated 47 million patients in the five major EU markets, the US and Japan, according to the company.
Image: Micrograph of bacterial vaginosis. Photo: Courtesy of Per Grinsted / Medicinsk Webdesign.