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

NCT02173184 | Unknown Phase 3

• 1 other identifier: LATVAC 1-2013-HU
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

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

Keywords

bacterial vaginosis; Gynevac Lactobacillus vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks from the time of last vaccine administration (+3 days maximum)

Secondary Outcomes (5)

• Clearance of BV infection according to Amsel criteria

  3 weeks from the time of last vaccine administration (+3 days maximum)

• Clearance of BV infection according to Nugent Score

  3 weeks from the time of last vaccine administration (+3 days maximum)

• Overall therapeutic failure

  3 weeks from the time of last vaccine administration (+3 days maximum)

• Change in Nugent Score

  3 weeks from the time of last vaccine administration (+3 days maximum)

• Change in pre- and post-vaccination IgA, IL17, and IFNγ

  3 weeks from the time of last vaccine administration (+3 days maximum)

Other Outcomes (1)

• Number of participants with AEs

  3 weeks from the time of last vaccine administration (+3 days maximum)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo vehicle (0.9% NaCl solution)

Biological: Placebo

Gynevac

EXPERIMENTAL

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

Biological: Gynevac

Interventions

Gynevac 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).

Gynevac

Placebo 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).

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amvac Kft.: lead

Study Sites (8)

Kaali Institute

Budapest, H-1125, Hungary

NOT YET RECRUITING

Zsebok Zoltan Outpatient Center, Dept. of Gynecology

Budapest, H-1183, Hungary

RECRUITING

Kaali Institute

Debrecen, H-4032, Hungary

RECRUITING

Kaali Institute

Győr, H-9026, Hungary

RECRUITING

Kaali Institute

Kaposvár, H-7400, Hungary

RECRUITING

Kaali Institute

Miskolc, H-3526, Hungary

NOT YET RECRUITING

Donatella 99 Bt.

Szentes, H-6600, Hungary

RECRUITING

Pannon Reproduction Institute

Tapolca, H-8300, Hungary

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Attila Török, MD

  Pannon Reprodukciós intézet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferenc Zimonyi

CONTACT

+36 1 269 9596; zimonyi@amvac.eu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

HU (8)