NCT06190509

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

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.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 251 (estimated)
• Sponsor: LimmaTech Biologics AG · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a First Time In Human (FTIH), phase I/II, double-blind, randomized, placebo-controlled study to evaluate the safety, immunogenicity and preliminary efficacy of the candidate pentavalent bioconjugate vaccine (Candi5V), administered twice, 2 months apart, with or without adjuvant. The study will be conducted in two subsequent steps: Step 1 (safety cohort): staggered enrolment of small groups of women with history of RVVC, sequentially administered with the half dose of Candi5V non-adjuvanted and with adjuvant or placebo, followed by groups administered with the target dose of Candi5V non-adjuvanted and with adjuvant or placebo. Step 2 (target cohort): concurrent enrolment of women with history of RVVC, randomized 1:1:1 to Candi5V, Candi5V + adjuvant and placebo. All study participants will be followed for 12 months after the second vaccination, to assess the vaccine safety profile, the immunological response and the recurrence of any VVC episode.

Conditions

• Recurrent Vulvovaginal Candidiasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-06
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2024-01-05
• Last updated: 2026-03-04

Locations

7 sites across 2 countries: Belgium, Poland