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

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ClinicalTrials.gov Identifier: NCT02173184
Recruitment Status : Unknown
Verified October 2014 by Amvac Kft..
Recruitment status was:  Recruiting
First Posted : June 24, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Amvac Kft.

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

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Biological: Gynevac Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

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).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173184


Contacts
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Contact: Ferenc Zimonyi +36 1 269 9596 zimonyi@amvac.eu

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

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Responsible Party: Amvac Kft.
ClinicalTrials.gov Identifier: NCT02173184     History of Changes
Other Study ID Numbers: LATVAC 1-2013-HU
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by Amvac Kft.:
bacterial vaginosis
Gynevac Lactobacillus vaccine
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Vaccines
Immunologic Factors
Physiological Effects of Drugs