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

NCT ID: NCT02173184

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-07-31

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

Conditions

Bacterial Vaginosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo vehicle (0.9% NaCl solution)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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).

Gynevac

Gynevac suspension for injection, a vaccine containing Lactobacillus strains 15, 34, 79, 84, 127 inactivated by formaldehyde in 0.9% NaCl solution

Group Type: EXPERIMENTAL

Gynevac

Intervention Type: BIOLOGICAL

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Amvac Kft.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Attila Török, MD

Role: PRINCIPAL_INVESTIGATOR

Pannon Reprodukciós intézet

Locations

Kaali Institute

Budapest, , Hungary

Site Status: NOT_YET_RECRUITING

Zsebok Zoltan Outpatient Center, Dept. of Gynecology

Budapest, , Hungary

Site Status: RECRUITING

Kaali Institute

Debrecen, , Hungary

Site Status: RECRUITING

Kaali Institute

Győr, , Hungary

Site Status: RECRUITING

Kaali Institute

Kaposvár, , Hungary

Site Status: RECRUITING

Kaali Institute

Miskolc, , Hungary

Site Status: NOT_YET_RECRUITING

Donatella 99 Bt.

Szentes, , Hungary

Site Status: RECRUITING

Pannon Reproduction Institute

Tapolca, , Hungary

Site Status: RECRUITING

Countries

Hungary

Central Contacts

Ferenc Zimonyi

Role: CONTACT

zimonyi@amvac.eu

+36 1 269 9596

Facility Contacts

Ferenc Krizsa, MD

Role: primary

+36 1 202 2802

Dora Czang, MD

Role: primary

Bela Bodnar, MD

Role: primary

+36 52 537-517

Tamas Korosi, MD

Role: primary

+36 96 511 210

Zoltan Manfai, MD

Role: primary

+36 82 801 801

Imre Molnar, MD

Role: primary

+36 46 347 600

Gabriella Gyovai, MD

Role: primary

Attila Torok, MD

Role: primary

+36 87 510 365

Other Identifiers

LATVAC 1-2013-HU

Identifier Type: -

Identifier Source: org_study_id