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

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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.

NCT06190509•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.

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.

Eligibility

Age

18 - 50 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Good general health by medical history, laboratory findings and physical examination before receiving vaccination as judged by the Investigator.
•2. Documented history of R-VVC, defined as 3 or more VVC episodes in the previous year, of which:
•1. at least 3 can be documented by a visit at a physician's office OR are documented by antifungal drug use as proven by a retrospective pharmacist drug delivery list, or electronic prescription by a physician
•2. at least one is culture OR microscopy confirmed (Pap smear, wet mount or Gram stain for Candida spp).
•Note: patients on chronic long-term treatment with documented RVVC diagnosis with at least 3 VVC episodes within the previous 3 years before enrolment, of which:
•1. at least 3 can be documented by a visit at a physician's office OR are documented by antifungal drug use as proven by a retrospective pharmacist drug delivery list, or electronic prescription by a physician
•2. at least one is culture OR lab-based microscopy confirmed for Candida spp (Pap smear, wet mount or Gram stain).
•3. Participant who is willing and able to comply with the requirements of the protocol (e.g., completion of the study diary, return for follow-up visits).
•4. Signed written informed consent obtained from the participant.
•5. Females between 18-47 years (inclusive) of age at the time of the first vaccination practicing highly effective birth control from prior to first vaccination until at least 28 days after the last vaccination agreed by participants. Females between 48-50 years (inclusive) can be included if they are using combined (estrogen and progesteron containing) hormonal oral contraceptives from prior to first vaccination until at least 1 month after the last vaccination as agreed by participants.
+1 more criteria

Exclusion Criteria

•1. Health condition that, in the opinion of the Investigator, may interfere with optimal participation in the study or place the participant at increased risk of adverse events.
•2. Acute disease including VVC-symptoms at the time of vaccination.
•3. Any deviation from the normal range in biochemistry or haematology blood tests or urine safety laboratory clinically significant in the opinion of the Investigator.
•4. Clinically significant abnormalities on physical examination.
•5. Suspected or known hypersensitivity (including allergy) to any of the medicinal products or medical equipment whose use is foreseen in this study.
•6. History of allergy to any vaccine.
•7. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws (e.g., coagulation disorder).
•8. VVC therapy within 1 month preceding the 1st vaccination (participants meeting this criterion will be followed and may be re-screened at a later timepoint following a negative culture).
•9. Participants with cervical diseases, or any other vulvovaginal conditions that may influence vaccine efficacy and VVC treatment.
•10. Known or suspected impairment of immunological function, documented Human Immunodeficiency Virus (HIV) infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder.
+15 more criteria

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

Key Dates

Start Date

December 6, 2023

Primary Completion Date

April 30, 2027

Completion Date

April 30, 2027

Last Updated

March 4, 2026

Enrollment

251

ESTIMATED participants

Conditions

Recurrent Vulvovaginal Candidiasis

Interventions

Vaccine

BIOLOGICAL

Vaccine

BIOLOGICAL

Vaccine

BIOLOGICAL

A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

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Recurrent Vulvovaginal Candidiasis

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COMPLETEDPHASE4

Study of Lactobacillus in Adjuvant Treatment of RVVC

NCT04699240

Recurrent Vulvovaginal Candidiasis

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COMPLETEDPHASE1

Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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