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

NCT06190509 | Active Not Recruiting Phase 1

• 2 other identifiers: Candi5V012023-507527-28-00
• Study Type: interventional
• Target: 251
• Locations: 2 countries
• Sites: 7

Brief 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

Keywords

Recurrent Vulvovaginal Candidiasis; Vulvovaginal Candidiasis; Candida Vaccine

Outcome Measures

Primary Outcomes (9)

• - Percentage of participants with solicited AEs at the administration site during the 7-day follow-up period (day of administration and 6 following days) after each dose, in the Candi5V arms and the placebo arm.

  within 0-7 days after vaccination

• - Percentage of participants with each solicited systemic AE during the 7-day follow-up period (day of administration and 6 following days) after each dose, in the Candi5V arms and the placebo arm.

  within 0-7 days after vaccination

• - Percentage of participants with unsolicited AEs during the 28-day follow-up period (day of administration and 27 following days) after each dose, in the Candi5V arms and the placebo arm.

  within 0-28 days after vaccination

• - Percentage of participants with SAEs from the first dose to study end in the Candi5V arms and the placebo arm.

  up to 12 months after second vaccination

• - Percentage of participants with medically relevant AEs from the first dose to study end.

  up to 12 months after second vaccination

• - Percentage of participants with AEs leading to withdrawal from the study or to the withholding of further study intervention administration, during their entire study participation, in the Candi5V arms and the placebo arm.

  up to 12 months after second vaccination

• - Percentage of participants with haematological and biochemical laboratory abnormalities at 7-days post-dose compared to pre-dose values (V3 vs V2, V7 vs V6) in the Candi5V arms and the placebo arm.

  within 0-7 days after vaccination

• - Percentage of participants with AESIs (e.g., pIMDs, vulvovaginal candidiasis, extravaginal candidiasis or systemic fungal infection) from the first dose to study end in the Candi5V arms and the placebo arm.

  up to 12 months after second vaccination

• - Evaluation of geometric mean titers (GMTs) for serum IgG against the five Candida antigens included in Candi5V, between baseline and post-vaccination samples collected at V8 (i.e., 28 days after the second vaccination).

  within 0-28 days after vaccination

Secondary Outcomes (18)

• - Evaluation of geometric mean titers (GMTs) for serum IgG against the five Candida antigens included in Candi5V, between baseline and post-vaccination samples collected at V5, in the Candi5V arms and the placebo arm.

  within 0-28 days after vaccination

• - Evaluation of geometric mean ratios (GMRs) for serum IgG against the five Candida antigens included in Candi5V, between baseline and post-vaccination (fold increase) on samples collected at V5 and V8, in the Candi5V arms and the placebo arm.

  within 0-28 days after vaccination

• - Percentage of participants in the Candi5V arms and the placebo arm achieving at least a four-fold rise (seroconversion) in the GMT of serum IgG against the Candi5V antigens at V5 and V8, compared to baseline.

  within 0-28 days after vaccination

• - Evaluation of geometric mean titers (GMTs) for serum IgA against the five Candida antigens included in Candi5V, between baseline and post-vaccination samples collected at V8, in the Candi5V arms and the placebo arm.

  within 0-28 days after vaccination

• - Evaluation of GMRs for serum IgA against the five Candida antigens included in Candi5V between baseline and post-vaccination (fold increase) on samples collected at V8, in the Candi5V arms and the placebo arm.

  within 0-28 days after vaccination

Study Arms (5)

Candi5V half dose

ACTIVE COMPARATOR

Biological: Vaccine

Candi5V half dose + adjuvant

ACTIVE COMPARATOR

Biological: Vaccine

Candi5V target dose

ACTIVE COMPARATOR

Biological: Vaccine

Candi5V target dose + adjuvant

ACTIVE COMPARATOR

Biological: Vaccine

Placebo

PLACEBO COMPARATOR

Biological: Vaccine

Interventions

Vaccine BIOLOGICAL

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

Candi5V half dose + adjuvant; Candi5V target dose + adjuvant

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health by medical history, laboratory findings and physical examination before receiving vaccination as judged by the Investigator.
• Documented history of R-VVC, defined as 3 or more VVC episodes in the previous year, of which:
• 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
• 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:
• 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
• at least one is culture OR lab-based microscopy confirmed for Candida spp (Pap smear, wet mount or Gram stain).
• may also be considered eligible if not on any antifungal treatment for at least 1-month preceding vaccination.
• 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).
• Signed written informed consent obtained from the participant.
• 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.
• Note: highly effective birth control is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined (estrogen and progesteron containing) hormonal contraceptives associated with inhibition of ovulation (oral or intravaginal or transdermal); progesteron-only hormonal contraceptives associated with inhibition of ovulation (oral or injectable or implantable); intrauterine device; intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; sexual abstinence; vasectomized partner (male partner sterilisation at least 6 months prior to the female participant's entry into the study, and if the relationship is monogamous.

You may not qualify if:

• 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.
• Acute disease including VVC-symptoms at the time of vaccination.
• Any deviation from the normal range in biochemistry or haematology blood tests or urine safety laboratory clinically significant in the opinion of the Investigator.
• Clinically significant abnormalities on physical examination.
• Suspected or known hypersensitivity (including allergy) to any of the medicinal products or medical equipment whose use is foreseen in this study.
• History of allergy to any vaccine.
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws (e.g., coagulation disorder).
• 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).
• Participants with cervical diseases, or any other vulvovaginal conditions that may influence vaccine efficacy and VVC treatment.
• Known or suspected impairment of immunological function, documented Human Immunodeficiency Virus (HIV) infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder.
• Positive blood test for HBsAg, HCV, HIV-1/2.
• History of systemic administration of immunosuppressive drugs, i.e., corticosteroids, (PO/IV/IM) within the last month prior to 1st vaccination or for more than 14 consecutive days within 3 months prior to 1st vaccination, until the last blood sampling visit (i.e., prednisone or equivalent ≥20 mg/day). Inhaled and topical steroids are allowed.
• Administration of antineoplastic and immune-modulating agents or chemotherapy within 3 months prior to informed consent.
• Planned or actual administration of any licensed vaccine within 14 days prior to each vaccination and 30 days after each vaccination. Note: In case an emergency mass vaccination for an unforeseen public health threat is organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary, for that vaccine provided it is licensed and used according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational interventional vaccine/product (pharmaceutical product).

Sponsors & Collaborators

• LimmaTech Biologics AG: lead
• GlaxoSmithKline: collaborator

Study Sites (7)

Femicare

Tienen, Tienen, 3300, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Aidport sp.z o.o.

Skórzewo, Poznan, 60-185, Poland

Location

IN-VIVO Sp. z o.o.

Bydgoszcz, 85-048, Poland

Location

NZOZ Medem

Katowice, 40-301, Poland

Location

Velocity Nova sp. z o.o

Lublin, 20-362, Poland

Location

MTZ Clinical Research powered by Pratia

Warsaw, 02-172, Poland

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: December 6, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 4, 2026

Record last verified: 2025-09

Locations

BE (2); PL (5)