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ACTIVE NOT RECRUITING
NCT06190509
PHASE1/PHASE2

Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study

Sponsor: LimmaTech Biologics AG

View on ClinicalTrials.gov

Summary

In this study, the pentavalent bioconjugate candidate vaccine (Candi5V) against Candida will be tested to obtain first-time-in-human (FTIH) data on its safety, immunogenicity, and preliminary efficacy in women with recurrent vulvovaginal candidiasis.

Official title: Candi5V01 A FTIH Phase I/II Randomized and Controlled Study to Test Safety, Immunogenicity and Preliminary Efficacy of a Pentavalent Bioconjugate Vaccine (Candi5V) Against Candida in Women With Recurrent Vulvovaginal Candidiasis.

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

251

Start Date

2023-12-06

Completion Date

2027-04-30

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

BIOLOGICAL

Vaccine

The candidate pentavalent bioconjugate vaccine (Candi5V) is administered twice, 2 months apart, with adjuvant.

BIOLOGICAL

Vaccine

The candidate pentavalent bioconjugate vaccine (Candi5V) is administered twice, 2 months apart without adjuvant

BIOLOGICAL

Vaccine

The placebo is administered twice, 2 months apart

Locations (7)

Femicare

Tienen, Tienen, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Aidport sp.z o.o.

Skórzewo, Poznan, Poland

IN-VIVO Sp. z o.o.

Bydgoszcz, Poland

NZOZ Medem

Katowice, Poland

Velocity Nova sp. z o.o

Lublin, Poland

MTZ Clinical Research powered by Pratia

Warsaw, Poland