BNT331 for Bacterial Vaginosis

Recruiting at 6 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: BioNTech SE

Must not be taking: Antifungals, Antimicrobials, Vaginal hormones

Disqualifiers: Pregnancy, Genital lesions, Drug abuse, others

Compensation: Varies

Number of Visits: 1

102 Participants Needed

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. ^{1 2 3 4 5}

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility 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.

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

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

Treatment Details

Interventions

• BNT331

Trial Overview 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.

Participant Groups

Group I: BNT331 - Part B Dose 2 Experimental Treatment 1 Intervention

Fixed dose for 5 consecutive days

Group II: BNT331 - Part B Dose 1 Experimental Treatment 1 Intervention

Fixed dose for 5 consecutive days

Group III: BNT331 - Part A Experimental Treatment 1 Intervention

Single ascending dose levels

Group IV: Placebo - Part B Placebo Group 1 Intervention

Multiple dose

Group V: Placebo - Part A Placebo Group 1 Intervention

Single dose

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Findings from Research

High dose vaginal metronidazole therapy (HDM) provided short-term remission in 68% of patients with recurrent bacterial vaginosis (RBV) who did not respond to standard oral treatment, indicating its potential as an effective alternative.

Patients with higher diagnostic scores indicating prolonged dysbiosis were more likely to experience recurrence after HDM, suggesting that certain pre-treatment conditions may predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional oral and secondary high dose vaginal metronidazole therapy for recurrent bacterial vaginosis: clinical outcomes, impacts of sex and menses. Sobel, JD., Kaur, N., Woznicki, NA., et al.[2022]

In a study involving 577 patients, a single dose of secnidazole (2 g) was found to be as effective as the standard multiple-dose metronidazole (500 mg twice daily for seven days) in treating bacterial vaginosis, with cure rates of 60.1% and 59.5% respectively.

Both treatments had comparable safety profiles, suggesting that secnidazole offers a convenient alternative for patients and clinicians in managing bacterial vaginosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole. Bohbot, JM., Vicaut, E., Fagnen, D., et al.[2021]

Bacterial vaginosis is a prevalent condition that can lead to unpleasant vaginal discharge and is linked to increased risks of sexually transmitted infections and negative pregnancy outcomes.

This review highlights existing treatment options for bacterial vaginosis and discusses new therapies being developed to improve management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibacterial treatment of bacterial vaginosis: current and emerging therapies. Menard, JP.[2021]

A 14-day treatment with metronidazole significantly improved cure rates for bacterial vaginosis (BV) compared to a 7-day treatment, although the benefits did not last beyond 21 days, indicating potential relapse or reinfection.

Adding azithromycin to the treatment regimen did not provide any additional benefit, while factors like lower baseline Nugent scores and practicing safe sex were associated with higher cure rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of the duration of therapy with metronidazole plus or minus azithromycin for treatment of symptomatic bacterial vaginosis. Schwebke, JR., Desmond, RA.[2013]

In a study of 152 patients with bacterial vaginosis, both oral and vaginal treatments with ornidazole and oral secnidazole combined with vaginal metronidazole achieved a 100% cure rate, demonstrating their high efficacy.

The results suggest that using a combination of oral and vaginal medications is more effective than using vaginal treatments alone, indicating a potential strategy for improving treatment outcomes in bacterial vaginosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of bacterial vaginosis with oral or vaginal ornidazole, secnidazole and metronidazole. Saraçoğlu, F., Göl, K., Sahin, I., et al.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Conventional oral and secondary high dose vaginal metronidazole therapy for recurrent bacterial vaginosis: clinical outcomes, impacts of sex and menses. [2022]

2. Egypt pubmed.ncbi.nlm.nih.gov

Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Antibacterial treatment of bacterial vaginosis: current and emerging therapies. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of the duration of therapy with metronidazole plus or minus azithromycin for treatment of symptomatic bacterial vaginosis. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of bacterial vaginosis with oral or vaginal ornidazole, secnidazole and metronidazole. [2019]