Recurrent Vulvovaginal Candidiasis Clinical Trial
Official title:
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.
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05074602 -
A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis
|
Phase 3 | |
| Completed |
NCT04029116 -
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
|
Phase 3 | |
| Active, not recruiting |
NCT04734405 -
A Phase IIb/III Study of Prof-001 for the Treatment of Patients With Recurrent Vulvovaginal Candidiasis (RVVC)
|
Phase 2/Phase 3 | |
| Completed |
NCT01067131 -
Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection
|
Phase 1 | |
| Completed |
NCT03840616 -
Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
|
Phase 3 | |
| Recruiting |
NCT04699240 -
Study of Lactobacillus in Adjuvant Treatment of RVVC
|
Phase 4 | |
| Not yet recruiting |
NCT04639544 -
Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
|
N/A | |
| Completed |
NCT02267382 -
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
|
Phase 2 | |
| Completed |
NCT03561701 -
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
|
Phase 3 | |
| Completed |
NCT03562156 -
A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
|
Phase 3 | |
| Enrolling by invitation |
NCT05795491 -
Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis
|
N/A | |
| Completed |
NCT03059992 -
Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
|
Phase 3 |