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

Amvac Kft.

Status and phase: Unknown; Phase 3

Conditions: Bacterial Vaginosis

Treatments: Biological: Placebo; Biological: Gynevac

Study type: Interventional

Funder types: Industry

Identifiers

NCT02173184

LATVAC 1-2013-HU

Details and patient eligibility

About

To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot treatment period in patients with bacterial vaginosis, based on the Nugent Score and the Amsel criteria

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult premenopausal females, 18 years and older.
• Mentally competent patients that can comply with the study protocol and are able to complete 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 specific treatment of vaginosis or to prevent the development of acute vaginitis and which may affect 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 the interpretation 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 of randomization.
• 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 cervical intraepithelial 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 or unstable 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 days prior to study randomization (e.g. douches, female deodorant sprays, spermicides, condoms, tampons, and diaphragms). Patients should also refrain from using intravaginal products 3 days prior to each study visit.
• Patients who do not abstain from vaginal intercourse during at least 3 days prior to each study visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo vehicle (0.9% NaCl solution)

Treatment:

Biological: Placebo

Gynevac

Experimental group

Description:

Gynevac suspension for injection, a vaccine containing Lactobacillus strains 15, 34, 79, 84, 127 inactivated by formaldehyde in 0.9% NaCl solution

Treatment:

Biological: Gynevac