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Monoclonal Antibodies

BNT331 for Bacterial Vaginosis

Phase 1
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant reported assigned female sex at birth, at least 18 years of age and pre-menopausal, as determined by the investigator
Not menstruating or having vaginal bleeding at specified visits
Must not have
Had received antifungal or antimicrobial therapy within specified days prior to Visit 1
Currently suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal disease symptoms including symptomatic VVC or infection with STI (Part B only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 6 days post-first dose up to 30 days post-first dose

Summary

This trial is divided into two parts and will test the safety, effectiveness, and other aspects of a drug called BNT331. The first part will involve healthy women, while the second part will involve

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects are not listed, but generally could include reactions at the injection site, nausea, headache, or other symptoms as determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not experiencing menstrual or vaginal bleeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken antifungal or antibiotic medication recently.
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I might have a vaginal condition not related to the study's focus.
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I have active genital lesions or conditions.
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I use a Copper IUD or vaginal hormonal products for birth control.
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I have had cancer in the past 5 years, including cervical, vaginal, or vulvar cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 6 days post-first dose up to 30 days post-first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 6 days post-first dose up to 30 days post-first dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until the Follow-up Visit
Part A - Percentage of participants with serious adverse events (SAEs) with onset after first treatment dose and until the Follow-up Visit
Part B - Percentage of participants with SAEs with onset after first treatment dose and until the Late Follow-up Visit
+1 more
Secondary study objectives
Part A - Anti-drug antibody (ADA) prevalence or change of binding titers against BNT331 active substance in blood before study treatment and at the Follow-up Visit
Part A - Serum concentrations of BNT331 active substance at pre-specified timepoints
Part B - ADA prevalence or change of binding titers against BNT331 active substance in blood before study treatment and at the Test of Cure (ToC) Visit
+4 more

Trial Design

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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioNTech SELead Sponsor
71 Previous Clinical Trials
111,063 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
36 Previous Clinical Trials
9,892 Total Patients Enrolled
~58 spots leftby May 2025
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