Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis

Inclusion Criteria:

• Adult premenopausal females, 18 years and older.

• Mentally competent patients that can comply with the study protocol and are able tocomplete and keep or study related material (patient diaries, etc.).

• Signed and dated written informed consent.

• Clinical diagnosis of BV according to Amsel criteria

• Gram stains Nugent Score ≥7 or Nugent Score 4-6 with the presence of clue cells

• Patient does not need an anti-infective treatment which would be required for specifictreatment of vaginosis or to prevent the development of acute vaginitis and which mayaffect treatment outcome of BV.

• Negative pregnancy test at screening.

Exclusion Criteria:

• Patients with other infectious causes of vulvovaginitis (e.g. Vaginal candidiasis,Trichomonas vaginalis).

• Patients with another vaginal or vulvar condition, which would confound theinterpretation of clinical and or therapeutic response.

• Patients who received antifungal or antimicrobial therapy (systemic or intravaginal),as part of standard clinical practice, or clinical trial, within 14 days ofrandomization.

• Patients who are diagnosed with a chronic inflammatory disease (Rheumatoid Arthritis,psoriasis, Crohn's disease, Coeliac disease, spondyloarthritis rheumatica etc.)

• Women who are scheduled to be under treatment during the study period for cervicalintraepithelial neoplasia (CIN) or cervical carcinoma.

• Pregnancy or lactation.

• Patients with known hypersensitivity to formaldehyde.

• Patients undergoing antibiotic treatment.

• Patients with acute polyarthritis, known serious cardiac, liver, kidney diseases orunstable diabetes mellitus.

• Known abnormalities of the blood circulation or of the haemopoietic system.

• Use of any investigational drug within 30 days from randomization.

• Patients who do not abstain from use of intravaginal products for at least 7 daysprior to study randomization (e.g. douches, female deodorant sprays, spermicides,condoms, tampons, and diaphragms). Patients should also refrain from usingintravaginal products 3 days prior to each study visit.

• Patients who do not abstain from vaginal intercourse during at least 3 days prior toeach study visit.