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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
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).
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).
Kaali Institute
Budapest, Hungary
NOT_YET_RECRUITINGZsebok Zoltan Outpatient Center, Dept. of Gynecology
Budapest, Hungary
RECRUITINGKaali Institute
Debrecen, Hungary
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.
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
Change in pre- and post-vaccination IgA, IL17, and IFNγ
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Kaali Institute
Győr, Hungary
RECRUITINGKaali Institute
Kaposvár, Hungary
RECRUITINGKaali Institute
Miskolc, Hungary
NOT_YET_RECRUITINGDonatella 99 Bt.
Szentes, Hungary
RECRUITINGPannon Reproduction Institute
Tapolca, Hungary
RECRUITINGMedian difference from baseline of IgA, IL17 and IFNγ in PBMCs isolated on week 7 by participants treated with Gynevac or Placebo
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)