Safety and Efficacy Study of Gynevac Lactobacillus Vaccin... | NCT02173184

NCT02173184

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Measure	Description	Time Frame
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)

Eligibility Module

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.

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis