BNT331 for Bacterial Vaginosis
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: BioNTech SE
Must not be taking: Antifungals, Antimicrobials, Vaginal hormones
Disqualifiers: Pregnancy, Genital lesions, Drug abuse, others
Trial Summary
What is the purpose of this trial?This is a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (for Part B) of BNT331 in healthy women (Part A) and in women diagnosed with bacterial vaginosis (BV) (Part B).
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have received antifungal or antimicrobial therapy within 14 days before the first visit. It's best to discuss your specific medications with the trial team.
What data supports the idea that BNT331 for Bacterial Vaginosis is an effective treatment?
The available research does not provide specific data on BNT331 for treating Bacterial Vaginosis. Instead, it discusses other treatments like metronidazole, secnidazole, and ornidazole. These treatments are commonly used, but they have issues like high recurrence rates. Without specific data on BNT331, we can't compare its effectiveness to these other treatments.
12345Eligibility Criteria
Part A of the trial is for healthy women, while Part B is for women with bacterial vaginosis. Participants must meet specific health criteria not detailed here.Inclusion Criteria
I am not experiencing menstrual or vaginal bleeding.
Healthy according to screening procedures (Part A) or suffering from BV but otherwise healthy (Part B)
My condition has been stable before joining the trial.
+10 more
Exclusion Criteria
I have had cancer in the past 5 years, including cervical, vaginal, or vulvar cancer.
Pregnant, lactating, or planning to become pregnant during their study participation and for specified days after visits
Participated in any investigational study within specified days before Visit 1 or currently participating/plans to participate in any investigational or observational study
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Part A
Participants receive a single ascending dose of BNT331 or placebo
1 day
1 visit (in-person)
Follow-up Part A
Participants are monitored for safety and adverse events after the single dose
12 days
Treatment Part B
Participants with bacterial vaginosis receive multiple ascending doses of BNT331 or placebo for 5 consecutive days
5 days
Self-administered at home
Follow-up Part B
Participants are monitored for safety, adverse events, and clinical outcomes after multiple doses
120 days
Participant Groups
The study tests BNT331 against a placebo in two parts: first to check safety in healthy women and then its effectiveness in those with bacterial vaginosis.
5Treatment groups
Experimental Treatment
Placebo Group
Group I: BNT331 - Part B Dose 2Experimental Treatment1 Intervention
Fixed dose for 5 consecutive days
Group II: BNT331 - Part B Dose 1Experimental Treatment1 Intervention
Fixed dose for 5 consecutive days
Group III: BNT331 - Part AExperimental Treatment1 Intervention
Single ascending dose levels
Group IV: Placebo - Part BPlacebo Group1 Intervention
Multiple dose
Group V: Placebo - Part APlacebo Group1 Intervention
Single dose
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UAB Sexual Health Research ClinicBirmingham, AL
Praetorian Pharmaceutical Research, LLCMarrero, LA
Southern Clinical Research Associates - MetairieMetairie, LA
Women Under Study, LLCNew Orleans, LA
More Trial Locations
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Who Is Running the Clinical Trial?
BioNTech SELead Sponsor
References
Conventional oral and secondary high dose vaginal metronidazole therapy for recurrent bacterial vaginosis: clinical outcomes, impacts of sex and menses. [2022]Oral metronidazole therapy is the standard of care for bacterial vaginosis (BV), yet it has alarming rates of recurrence and refractory responses among recurrent BV (RBV) patients. This study addresses whether high dose vaginal metronidazole therapy (HDM) is beneficial in RBV patients who fail after standard of care (SOC) therapy, whether diagnostic test scores proximal to the HDM predict clinical outcome, and whether menses, coitus, or race influences therapy outcome.
Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole. [2021]Multiple-dose metronidazole oral therapy is currently the reference treatment for bacterial vaginosis (BV). This double-blind, double-dummy, noninferiority study compared the efficacy of secnidazole, another nitroimidazole with pharmacokinetics allowing a single dose regimen, to this standard treatment.
Antibacterial treatment of bacterial vaginosis: current and emerging therapies. [2021]Bacterial vaginosis is a common cause of malodorous vaginal discharge. It is also associated with sexually transmitted infections and adverse pregnancy outcomes. The magnitude of the gynecological and obstetrical consequences has stimulated therapeutic research and led to the testing of several therapies. The objective of this work is to present the currently available therapeutic strategies for the treatment of bacterial vaginosis and associated recommendations, and discuss the emerging therapies.
A randomized trial of the duration of therapy with metronidazole plus or minus azithromycin for treatment of symptomatic bacterial vaginosis. [2013]Bacterial vaginosis (BV) is the most common cause of vaginitis worldwide. Currently recommended treatments have poor efficacy and are associated with high rates of BV recurrence. We examined whether a longer duration of treatment with metronidazole or combination therapy with metronidazole and azithromycin would enhance the cure rates for BV. In addition, we examined factors other than drug therapy associated with cure.
Treatment of bacterial vaginosis with oral or vaginal ornidazole, secnidazole and metronidazole. [2019]To evaluate the clinical efficacy and tolerance of oral or vaginal ornidazole, secnidazole and metronidazole or their combinations for treatment of bacterial vaginosis.