Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recu… (NCT06190509) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study
Belgium, Poland251 participantsStarted 2023-12-06
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. 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).
✓. 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).
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
- 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.
Timeframe: within 0-7 days after vaccination
2
- 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.
Timeframe: within 0-7 days after vaccination
3
- 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.
Timeframe: within 0-28 days after vaccination
4
- Percentage of participants with SAEs from the first dose to study end in the Candi5V arms and the placebo arm.
Timeframe: up to 12 months after second vaccination
5
- Percentage of participants with medically relevant AEs from the first dose to study end.
Timeframe: up to 12 months after second vaccination
6
- 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.
Timeframe: up to 12 months after second 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).
7
- 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.
Timeframe: within 0-7 days after vaccination
8
- 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.
Timeframe: up to 12 months after second vaccination
9
- 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).