MedTrace Logo

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

NCT06190509 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

  • Recurrent Vulvovaginal Candidiasis

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • LimmaTech Biologics AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Belgium
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190509 on ClinicalTrials.gov