Back to resultsSafety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis
Primary Purpose
Bacterial Vaginosis
Status
Unknown status
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
Gynevac
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis focused on measuring bacterial vaginosis, Gynevac Lactobacillus vaccine
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.
Sites / Locations
- Kaali Institute
- Zsebok Zoltan Outpatient Center, Dept. of GynecologyRecruiting
- Kaali InstituteRecruiting
- Kaali InstituteRecruiting
- Kaali InstituteRecruiting
- Kaali Institute
- Donatella 99 Bt.Recruiting
- Pannon Reproduction InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Gynevac
Arm Description
Placebo vehicle (0.9% NaCl solution)
Gynevac suspension for injection, a vaccine containing Lactobacillus strains 15, 34, 79, 84, 127 inactivated by formaldehyde in 0.9% NaCl solution
Outcomes
Primary Outcome Measures
Therapeutic response
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 Outcome Measures
Clearance of BV infection according to Amsel criteria
The percentage of patients with clearance of infection according to Amsel criteria response (three of four from: physiological discharge, negative Whiff test, negative saline wet mount for clue cells and pH<4.7) in Gynevac® or placebo, at week 7.
Clearance of BV infection according to Nugent Score
The percentage of patients with clearance of infection according to Nugent Score (NS <4 or 4-6 with no presence of clue cells) in Gynevac® or placebo, at week 7.
Overall therapeutic failure
Percentage of patients whose overall therapeutic outcome is failure, defined as Amsel = cure and Nugent score ≥4 with the presence of clue cells and Amsel = failure regardless of Nugent Score, week 7.
Change in Nugent Score
Median difference between Gynevac or placebo of the change in Nugent Score from baseline to week 7.
Change in pre- and post-vaccination IgA, IL17, and IFNγ
Median difference from baseline of IgA, IL17 and IFNγ in PBMCs isolated on week 7 by participants treated with Gynevac or Placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02173184
Brief Title
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
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amvac Kft.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
bacterial vaginosis, Gynevac Lactobacillus vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo vehicle (0.9% NaCl solution)
Arm Title
Gynevac
Arm Type
Experimental
Arm Description
Gynevac suspension for injection, a vaccine containing Lactobacillus strains 15, 34, 79, 84, 127 inactivated by formaldehyde in 0.9% NaCl solution
Intervention Type
Biological
Intervention Name(s)
Gynevac
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Therapeutic response
Description
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.
Time Frame
3 weeks from the time of last vaccine administration (+3 days maximum)
Secondary Outcome Measure Information:
Title
Clearance of BV infection according to Amsel criteria
Description
The percentage of patients with clearance of infection according to Amsel criteria response (three of four from: physiological discharge, negative Whiff test, negative saline wet mount for clue cells and pH<4.7) in Gynevac® or placebo, at week 7.
Time Frame
3 weeks from the time of last vaccine administration (+3 days maximum)
Title
Clearance of BV infection according to Nugent Score
Description
The percentage of patients with clearance of infection according to Nugent Score (NS <4 or 4-6 with no presence of clue cells) in Gynevac® or placebo, at week 7.
Time Frame
3 weeks from the time of last vaccine administration (+3 days maximum)
Title
Overall therapeutic failure
Description
Percentage of patients whose overall therapeutic outcome is failure, defined as Amsel = cure and Nugent score ≥4 with the presence of clue cells and Amsel = failure regardless of Nugent Score, week 7.
Time Frame
3 weeks from the time of last vaccine administration (+3 days maximum)
Title
Change in Nugent Score
Description
Median difference between Gynevac or placebo of the change in Nugent Score from baseline to week 7.
Time Frame
3 weeks from the time of last vaccine administration (+3 days maximum)
Title
Change in pre- and post-vaccination IgA, IL17, and IFNγ
Description
Median difference from baseline of IgA, IL17 and IFNγ in PBMCs isolated on week 7 by participants treated with Gynevac or Placebo
Time Frame
3 weeks from the time of last vaccine administration (+3 days maximum)
Other Pre-specified Outcome Measures:
Title
Number of participants with AEs
Description
Number of patients with AEs by treatment group and overall. The incidence of AEs will be summarized by system organ class, severity, type of AE, relation of study drug and outcome.
Time Frame
3 weeks from the time of last vaccine administration (+3 days maximum)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ferenc Zimonyi
Phone
+36 1 269 9596
Email
zimonyi@amvac.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Attila Török, MD
Organizational Affiliation
Pannon Reprodukciós intézet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaali Institute
City
Budapest
ZIP/Postal Code
H-1125
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferenc Krizsa, MD
Phone
+36 1 202 2802
First Name & Middle Initial & Last Name & Degree
Ferenc Krizsa, MD
Facility Name
Zsebok Zoltan Outpatient Center, Dept. of Gynecology
City
Budapest
ZIP/Postal Code
H-1183
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dora Czang, MD
Facility Name
Kaali Institute
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bela Bodnar, MD
Phone
+36 52 537-517
First Name & Middle Initial & Last Name & Degree
Bela Bodnar, MD
Facility Name
Kaali Institute
City
Gyor
ZIP/Postal Code
H-9026
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamas Korosi, MD
Phone
+36 96 511 210
First Name & Middle Initial & Last Name & Degree
Tamas Korosi, MD
Facility Name
Kaali Institute
City
Kaposvar
ZIP/Postal Code
H-7400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoltan Manfai, MD
Phone
+36 82 801 801
First Name & Middle Initial & Last Name & Degree
Zoltan Manfai, MD
Facility Name
Kaali Institute
City
Miskolc
ZIP/Postal Code
H-3526
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imre Molnar, MD
Phone
+36 46 347 600
Facility Name
Donatella 99 Bt.
City
Szentes
ZIP/Postal Code
H-6600
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Gyovai, MD
Facility Name
Pannon Reproduction Institute
City
Tapolca
ZIP/Postal Code
H-8300
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attila Torok, MD
Phone
+36 87 510 365
First Name & Middle Initial & Last Name & Degree
Attila Török, MD
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis
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