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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 at 6 days after first dose and 21 to 30 days after the 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 days after first dose and 21 to 30 days after the first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 days after first dose and 21 to 30 days after the first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 days after first dose and 21 to 30 days after the 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 7 days post-dose

Part A - Percentage of participants with serious adverse events (SAEs) with onset after first treatment dose and until 7 days post-dose

Part B - Percentage of participants with SAEs with onset after first treatment dose and until 120 days after the first dose

+1 more

Secondary study objectives

Part A - Anti-drug antibody (ADA) prevalence and change of binding titers against BNT331 active substance in blood before study treatment and at 7 days post-dose

Part A - Serum concentrations of BNT331 active substance at pre-specified timepoints

Part B - ADA prevalence and change of binding titers against BNT331 active substance in blood before study treatment and at 6 days after the first dose, 21 to 30 days after the first dose, and 120 days after the first dose

+4 more