Clinical trial NCT02173184: Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bacterial Vaginosis
Keywords: bacterial vaginosis
Gynevac Lactobacillus vaccine
Lead sponsor: Amvac Kft.
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Therapeutic response
timeFrame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Secondary outcomes:
measure: Clearance of BV infection according to Amsel criteria
timeFrame: 3 weeks from the time of last vaccine administration (+3 days maximum)
measure: Clearance of BV infection according to Nugent Score
timeFrame: 3 weeks from the time of last vaccine administration (+3 days maximum)
measure: Overall therapeutic failure
timeFrame: 3 weeks from the time of last vaccine administration (+3 days maximum)
measure: Change in Nugent Score
timeFrame: 3 weeks from the time of last vaccine administration (+3 days maximum)
measure: Change in pre- and post-vaccination IgA, IL17, and IFNγ
timeFrame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Other outcomes:
measure: Number of participants with AEs
timeFrame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Locations:
city: Budapest
country: Hungary
facility: Kaali Institute
city: Budapest
country: Hungary
facility: Zsebok Zoltan Outpatient Center, Dept. of Gynecology
city: Debrecen
country: Hungary
facility: Kaali Institute
city: Gyor
country: Hungary
facility: Kaali Institute
city: Kaposvar
country: Hungary
facility: Kaali Institute
city: Miskolc
country: Hungary
facility: Kaali Institute
city: Szentes
country: Hungary
facility: Donatella 99 Bt.
city: Tapolca
country: Hungary
facility: Pannon Reproduction Institute
Study officials:
affiliation: Pannon Reprodukciós intézet
name: Attila Török, MD
role: PRINCIPAL_INVESTIGATOR
References: