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

October 28, 2014 updated by: Amvac Kft.

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
      • Budapest, Hungary, H-1125
        • Not yet recruiting
        • Kaáli Institute
        • Contact:
          • Ferenc Krizsa, MD
          • Phone Number: +36 1 202 2802
        • Principal Investigator:
          • Ferenc Krizsa, MD
      • Budapest, Hungary, H-1183
        • Recruiting
        • Zsebok Zoltan Outpatient Center, Dept. of Gynecology
        • Contact:
          • Dora Czang, MD
      • Debrecen, Hungary, H-4032
        • Recruiting
        • Kaáli Institute
        • Contact:
          • Bela Bodnar, MD
          • Phone Number: +36 52 537-517
        • Principal Investigator:
          • Bela Bodnar, MD
      • Gyor, Hungary, H-9026
        • Recruiting
        • Kaáli Institute
        • Contact:
          • Tamas Korosi, MD
          • Phone Number: +36 96 511 210
        • Principal Investigator:
          • Tamas Korosi, MD
      • Kaposvar, Hungary, H-7400
        • Recruiting
        • Kaáli Institute
        • Contact:
          • Zoltan Manfai, MD
          • Phone Number: +36 82 801 801
        • Principal Investigator:
          • Zoltan Manfai, MD
      • Miskolc, Hungary, H-3526
        • Not yet recruiting
        • Kaáli Institute
        • Contact:
          • Imre Molnar, MD
          • Phone Number: +36 46 347 600
      • Szentes, Hungary, H-6600
        • Recruiting
        • Donatella 99 Bt.
        • Contact:
          • Gabriella Gyovai, MD
      • Tapolca, Hungary, H-8300
        • Recruiting
        • Pannon Reproduction Institute
        • Contact:
          • Attila Torok, MD
          • Phone Number: +36 87 510 365
        • Principal Investigator:
          • Attila Török, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo vehicle (0.9% NaCl solution)
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).
Experimental: Gynevac
Gynevac suspension for injection, a vaccine containing Lactobacillus strains 15, 34, 79, 84, 127 inactivated by formaldehyde in 0.9% NaCl solution
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks from the time of last vaccine administration (+3 days maximum)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance of BV infection according to Amsel criteria
Time Frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
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.
3 weeks from the time of last vaccine administration (+3 days maximum)
Clearance of BV infection according to Nugent Score
Time Frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
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.
3 weeks from the time of last vaccine administration (+3 days maximum)
Overall therapeutic failure
Time Frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
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.
3 weeks from the time of last vaccine administration (+3 days maximum)
Change in Nugent Score
Time Frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Median difference between Gynevac or placebo of the change in Nugent Score from baseline to week 7.
3 weeks from the time of last vaccine administration (+3 days maximum)
Change in pre- and post-vaccination IgA, IL17, and IFNγ
Time Frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Median difference from baseline of IgA, IL17 and IFNγ in PBMCs isolated on week 7 by participants treated with Gynevac or Placebo
3 weeks from the time of last vaccine administration (+3 days maximum)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with AEs
Time Frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
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.
3 weeks from the time of last vaccine administration (+3 days maximum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amvac Kft.

Investigators

  • Principal Investigator: Attila Török, MD, Pannon Reprodukciós intézet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LATVAC 1-2013-HU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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