Trial | NCT02173184  Report issue

Title

Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis
Phase III, Randomized, Double Blind, Parallel Groups, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of the Lactobacillus Vaccine Gynevac, in the Treatment of Bacterial Vaginosis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    240
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
Study Started
Jun 30
2014
Primary Completion
Apr 30
2015
Anticipated
Study Completion
Jul 31
2015
Anticipated
Last Update
Oct 29
2014
Estimate

Biological Gynevac

1 IM injection of Gynevac per week, for 4 weeks (five injections in total). Vaccination can take place in no less than 7 days intervals (+3 days).

Biological Placebo

1 IM injection of Placebo per week, for 4 weeks (five injections in total). Vaccination can take place in no less than 7 days intervals (+3 days).

Placebo Placebo Comparator

Placebo vehicle (0.9% NaCl solution)

Gynevac Experimental

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

Criteria 

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.
No Results Posted