Bacterial VaginosisPhase 3NCT02173184
Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis
A Phase 3 study testing Gynevac in people with Bacterial Vaginosis, run by Amvac Kft. at 8 sites in Hungary.
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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Gynevac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 8 sitesHungary
- Study dates
- Jun 2014to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Hungary8 sites, 8 recruiting
- Not yet recruiting
Kaali Institute
Budapest, H-1125
Ferenc Krizsa, MD, +36 1 202 2802
Ferenc Krizsa, MD
- Recruiting
Zsebok Zoltan Outpatient Center, Dept. of Gynecology
Budapest, H-1183
Dora Czang, MD
- Recruiting
Kaali Institute
Debrecen, H-4032
Bela Bodnar, MD, +36 52 537-517
Bela Bodnar, MD
- Recruiting
Kaali Institute
Győr, H-9026
Tamas Korosi, MD, +36 96 511 210
Tamas Korosi, MD
- Recruiting
Kaali Institute
Kaposvár, H-7400
Zoltan Manfai, MD, +36 82 801 801
Zoltan Manfai, MD
- Not yet recruiting
Kaali Institute
Miskolc, H-3526
Imre Molnar, MD, +36 46 347 600
- Recruiting
Donatella 99 Bt.
Szentes, H-6600
Gabriella Gyovai, MD
- Recruiting
Pannon Reproduction Institute
Tapolca, H-8300
Attila Torok, MD, +36 87 510 365
Attila Török, MD
About this study
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
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
- Being tested
- Gynevac, Placebo
- Keywords
- bacterial vaginosis, Gynevac Lactobacillus vaccine
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GynevacBiological
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).
PlaceboBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo vehicle (0.9% NaCl solution) Receives: 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 Receives: Biological: Gynevac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks from the time of last vaccine administration (+3 days maximum)
Secondary outcomes (5)
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.
Measured: 3 weeks from the time of last vaccine administration (+3 days maximum)
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.
Measured: 3 weeks from the time of last vaccine administration (+3 days maximum)
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.
Measured: 3 weeks from the time of last vaccine administration (+3 days maximum)
Change in Nugent Score
Median difference between Gynevac or placebo of the change in Nugent Score from baseline to week 7.
Measured: 3 weeks from the time of last vaccine administration (+3 days maximum)
Change in pre- and post-vaccination IgA, IL17, and IFNγ
Median difference from baseline of IgA, IL17 and IFNγ in PBMCs isolated on week 7 by participants treated with Gynevac or Placebo
Measured: 3 weeks from the time of last vaccine administration (+3 days maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amvac Kft.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Attila Török, MD, Principal investigator, Pannon Reprodukciós intézet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173184
- Sponsor's protocol ID
- LATVAC 1-2013-HU
- Status last verified
- Oct 2014
- First submitted
- 23 Jun 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02173184
- Acronym / sponsor ID
- LATVAC 1-2013-HU
- Conditions
- Bacterial Vaginosis
- Keywords
- bacterial vaginosis, Gynevac Lactobacillus vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Amvac Kft.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboPlacebo vehicle (0.9% NaCl solution) |
| Gynevac | Experimental | Biological: GynevacGynevac suspension for injection, a vaccine containing Lactobacillus strains 15, 34, 79, 84, 127 inactivated by formaldehyde in 0.9% NaCl solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynevac1 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). | Biological | Gynevac |
| Placebo1 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). | Biological | Placebo |
Primary outcome
Therapeutic response
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
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.
5 secondary outcomes
Clearance of BV infection according to Amsel criteria
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Clearance of BV infection according to Nugent Score
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Overall therapeutic failure
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Change in Nugent Score
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Change in pre- and post-vaccination IgA, IL17, and IFNγ
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Attila Török, MD principal investigator
Pannon Reprodukciós intézet
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gynevac in people with Bacterial Vaginosis, run by Amvac Kft. at 8 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferenc Zimonyi (+36 1 269 9596, zimonyi@amvac.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic response (time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014; AzTrials last refreshed its copy on 8 Nov 2026.