ATVAC (Lactobacilli Therapeutic Vaccine study)
- Conditions
- Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]Bacterial vaginosis (Nugent score 4 or above)
- Registration Number
- EUCTR2013-002918-12-HU
- Lead Sponsor
- Amvac Kft
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1.18 years or above
2.Mentally competent
3.Written informed consent
4.Being able to comply with the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Hypersensitivity to formaldehyde, or any other of the components of Gynevac
2.Fever
3.Acute infectious disease
4.Immunosuppression
5.Acute polyarthritis
6.Serious cardiac, liver or kidney diseases
7.Abnormalities of the blood circulation or of the hemopoetic system
8.Ongoing antibiotic treatment
9.Use of any investigational drug within 30 days of V0
10. No former antibiotic treatment for any reasons in 14 days before study entry
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the efficacy and safety of a 5-shot treatment period with lactobacilli vaccination in patients with bacterial vaginosis and gathering information about dosage regimen;Secondary Objective: Secondary endpoint is the change of vaginal pH during the treatment period.<br>Other secondary endpoints are the patients subjective evaluation and changes in IgA levels (Microbe specific immunoglobulin answer)<br>;Primary end point(s): Nugent score changes in Vaginal smear;Timepoint(s) of evaluation of this end point: 63 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): vaginal pH change,<br>;Timepoint(s) of evaluation of this end point: 63 days