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

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.
• •11. Positive blood test for HBsAg, HCV, HIV-1/2.
• •12. 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.
• •13. Administration of antineoplastic and immune-modulating agents or chemotherapy within 3 months prior to informed consent.
• •14. 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.
• •15. 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).
• •16. Body Mass Index (BMI) ≤19 and ≥30.
• •17. History of any chronic or progressive disease that according to judgment of the Investigator could interfere with the study outcomes or pose a threat to the participant's health.
• •18. Received an investigational or non-registered product (medicinal drug or vaccine), other than the study vaccine within 3 months prior to 1st administration of study vaccine, or planned use during the study period.
• •19. Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine.
• •20. Blood donation equal or greater to 500 mL of blood drawn within 3 months preceding the first vaccination or planned during the study period as reported by the participant.
• •21. Use of any systemic antibiotic therapy within 1 week preceding each vaccination.
• •22. Participants with an elective surgical intervention, planned during the study period until 28 days after 2nd vaccination.
• •23. Females lactating, pregnant, or intending to become pregnant as reported by the participant, within at least one month post second vaccination. Note: in case of unintended and unknown pregnancy from prior to first vaccination until at least 1 month after the last vaccination, pregnancy should be followed to term, any premature terminations should be reported, and the health status of the mother and child including date of delivery and the child's gender and weight should be reported after delivery.
• •24. Current and/or history of chronic alcohol consumption and/or drug abuse.
• •25. History of immune-mediated disease.