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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02173184
• Other study ID #: LATVAC 1-2013-HU
• Status: Recruiting
• Phase: Phase 3
• First received: June 23, 2014
• Last updated: October 28, 2014
• Start date: June 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2014
• Source: Amvac Kft.
• Contact: Ferenc Zimonyi
• Phone: +36 1 269 9596
• Email: zimonyi[@]amvac.eu
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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).
• 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).

Locations

Country	Name	City	State
Hungary	Kaali Institute	Budapest
Hungary	Zsebok Zoltan Outpatient Center, Dept. of Gynecology	Budapest
Hungary	Kaali Institute	Debrecen
Hungary	Kaali Institute	Gyor
Hungary	Kaali Institute	Kaposvar
Hungary	Kaali Institute	Miskolc
Hungary	Donatella 99 Bt.	Szentes
Hungary	Pannon Reproduction Institute	Tapolca

Sponsors (1)

Lead Sponsor	Collaborator
Amvac Kft.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with AEs	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)	Yes
Primary	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)	No
Secondary	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.	3 weeks from the time of last vaccine administration (+3 days maximum)	No
Secondary	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.	3 weeks from the time of last vaccine administration (+3 days maximum)	No
Secondary	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.	3 weeks from the time of last vaccine administration (+3 days maximum)	No
Secondary	Change in Nugent Score	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)	No
Secondary	Change in pre- and post-vaccination IgA, IL17, and IFN?	Median difference from baseline of IgA, IL17 and IFN? 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)	No