Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection (ELINA)

Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product (BGY-1601-VT) as a First-line Monotherapy in Women With Acute Vaginal Infection: a Randomized, Double-blind, Placebo-controlled Study

The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product (BGY-1601-VT) intended as a first line of treatment in cases of acute vaginal infection without upfront microbiological confirmed diagnosis

Study Overview

• Status: Not yet recruiting
• Conditions: Bacterial Vaginosis; Vulvovaginal Candidiasis
• Intervention / Treatment: Other: PLACEBO; Drug: BGY-1601-VT

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Marine CARDONA; Email: contact@nexbiome.com
• Study Contact Backup: Name: Cyrille JEUNE; Phone Number: +33(0)772066938; Email: contact@nexbiome.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Post-menarche woman aged 18 to 50 years old (inclusive),
• With suspected Bacterial Vaginosis (BV) and/or Vulvovaginal Candidiasis (VVC), presenting symptoms of acute vaginal infection
• No clinically significant and relevant abnormalities of medical history (including mental disorders) or physical examination,
• Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form,

Exclusion Criteria:

• Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month
• Current herpes simplex flare-up in the genital area,
• Vulvar condyloma due to the human papilloma virus;
• Vulvar dermatoses (e.g.: psoriasis or lichenification);
• Clinical diagnosis of BV or VVC within 4 months;
• Treatment with any antibiotic or antifungal therapy (local or systemic) within 2 months, regardless of the indication;
• Treatment with any local treatment (probiotics, antiseptic, etc.) within 1 month, regardless of the indication;
• Participant using any intravaginal product (local contraceptive [spermicide, hormonal ring], moisturizer, tampon, intimate hygiene product, etc.);
• Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc.
• Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months;
• Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause;
• With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGY-1601-VT #2; BGY-1601#2: one verum tablet at D0 and one verum tablet at D2	Drug: BGY-1601-VT; Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.; Other Names: BGY-1601 vaginal tablet
Placebo Comparator: PLACEBO; Placebo: one placebo tablet at D0 and one placebo tablet at D2	Other: PLACEBO; Placebo; Other Names: Placebo vaginal tablet
Experimental: BGY-1601-VT #1; Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)	Other: PLACEBO; Placebo; Other Names: Placebo vaginal tablet; Drug: BGY-1601-VT; Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.; Other Names: BGY-1601 vaginal tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection	Percentage of responders with clinical cure at Visit 2 (V2) without rescue therapy	Visit 2 (V2) = 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo, dosing regimen #2 versus placebo, and dosing regimen #1 versus dosing regimen #2, to treat acute vaginal infection	Percentage of responders with clinical cure at each timepoints without rescue therapy Percentage of participants with improved symptoms at the timepoints	Visit 2 (7 days) and Visit 3 (28 days)
To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimethe safety of placebo #2, and	Adverse Events (AEs) reported	V2 (7 days) and V3 (28 days)
To compare the evolution of Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2.	quantitative Polymerase Chain Reaction (qPCR) Lcr35 in the vaginal microbiota	Visit 2 (7 days) and Visit 3 (28 days)

Collaborators and Investigators

• Sponsor: NEXBIOME THERAPEUTICS

Study record dates

Study Major Dates

• Study Start (Estimated): July 8, 2024
• Primary Completion (Estimated): December 28, 2025
• Study Completion (Estimated): February 26, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Bacterial Vaginosis (BV); Gardnerella vaginalis; Candida albicans; Vaginal infection; Anaerobic bacteria; Prevotella; Acute Vaginitis; Vulvovaginal Candidiasis (VVC)
• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Mycoses; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infections; Candidiasis; Vaginal Diseases; Vaginosis, Bacterial; Candidiasis, Vulvovaginal
• Other Study ID Numbers: BGY-1601-VT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No