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.
• 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.