Efficacy of the Vacucis Candida® Autovaccine

Launched by UNIVERSITY OF SANTIAGO DE COMPOSTELA · Mar 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a vaccine called Vacucis Candida® in treating oral candidiasis, which is a fungal infection in the mouth. This condition can be common, especially in people who have weakened immune systems, such as those who have undergone radiation therapy for head and neck cancers. The trial aims to see if the vaccine can help reduce the symptoms of this infection in patients who have received radiation treatment.

To participate in this trial, you need to be an adult who has received radiation in the head and neck area and has a confirmed case of oral candidiasis. You should be in stable health, without any active tumors, and not currently on antifungal medications. If you join the study, you will be informed about the trial details and will sign a consent form. Participants will either receive the vaccine or a placebo (a non-active substance) and will be monitored for changes in their symptoms. This trial is not yet recruiting, so there will be more information available soon for those who might be interested in joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a history of RT in the head and neck region that directly or indirectly involves any of the jaws.
• • Adult patients
• • Hemodynamically stable patients without contraindications to receive an autovaccine (see exclusion)
• • Patients with a stable oncological situation without active tumor
• • Patients who present candidiasis demonstrated by clinical examination (signs and symptoms of candidiasis) and microbiological (culture).
• Exclusion Criteria:
• • Minor patients
• • Pregnant patients
• • Patients with an unstable medical situation, both from a hemodynamic and oncological point of view (advanced tumors with metastases, recurrences or inoperable tumors)
• • Patients undergoing treatment with CT that involves an affectation of the immune system
• • Patient under treatment with antifungals for mycoses of any origin
• • Allergy to the active substance or to any of the other components of Vacucis.
• • Serious disorders of the immune system.
• • Diseases that severely affect immunity.
• • Presence of fever.
• • People with allergies to yeasts
• • People with allergy to chloramphenicol
• • Patients treated with MAOIs (monoamine oxidase inhibitors)