NCT02173184UnknownPhase 3
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
Amvac Kft.8 sites in 1 country240 target enrollmentStarted: June 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 240
- Locations
- 8
- Primary Endpoint
- Therapeutic response
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
Placebo Comparator
Placebo vehicle (0.9% NaCl solution)
Intervention: Placebo (Biological)
Gynevac
Experimental
Gynevac suspension for injection, a vaccine containing Lactobacillus strains 15, 34, 79, 84, 127 inactivated by formaldehyde in 0.9% NaCl solution
Intervention: Gynevac (Biological)
Outcomes
Primary Outcomes
Therapeutic response
Time Frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
The percentage of patients with remission according to Amsel's criteria at week 7: resolution of the clinical findings assessed at baseline, and remission according to Gram stain Nugent score: score \< 4 or 4 to 6 with no presence of clue cells at week 7.
Secondary Outcomes
- Clearance of BV infection according to Nugent Score(3 weeks from the time of last vaccine administration (+3 days maximum))
- Clearance of BV infection according to Amsel criteria(3 weeks from the time of last vaccine administration (+3 days maximum))
- Overall therapeutic failure(3 weeks from the time of last vaccine administration (+3 days maximum))
- Change in pre- and post-vaccination IgA, IL17, and IFNγ(3 weeks from the time of last vaccine administration (+3 days maximum))
- Change in Nugent Score(3 weeks from the time of last vaccine administration (+3 days maximum))
Investigators
Study Sites (8)
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