Oral CandidiasisNCT05289375
Efficacy of the Vacucis Candida® Autovaccine
A study testing Vacucis autovaccine in people with Oral Candidiasis and Oral Candidiasis Recurrent, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
Introduction: Oral candidiasis is an infectious disease caused by the growth of Candida colonies and their penetration into oral tissues when physical barriers and host defenses are weakened. It constitutes one of the most common pathologies within the field covered by Dentistry. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Candidiasis, Oral Candidiasis Recurrent, Radiotherapy; Complications
- What is being tested?
- Vacucis autovaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mario Pérez-Sayáns, PhD contact
Spain1 site
Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, 15785
Mario Pérez-Sayáns, PhD, 626233504 ext. 0034, mario.perez@usc.es
About this study
Official title: Efficacy of the Vacucis Candida® Autovaccine in the Management of Chronic Oral Candidiasis. Randomized Triple-blind Randomized Clinical Trial.
Introduction: Oral candidiasis is an infectious disease caused by the growth of Candida colonies and their penetration into oral tissues when physical barriers and host defenses are weakened. It constitutes one of the most common pathologies within the field covered by Dentistry. Candida infections are found in at least 80% of AIDS patients and in a third of HIV infection cases. Systemic diseases such as diabetes and a wide pharmacological arsenal to which the general population is subjected, are other causes of the increase in the prevalence of this disease. In addition, the high prevalence of oral sequelae (hyposialia) in the population over 65 years of age, due to the specific characteristics of this age group, such as multiple pathologies and drug use, explains the presence of this disease in this segment. of the population One of the great difficulties for the study of this disease is the diversity of predisposing factors, which do nothing but throw greater confusion into the results of the different works.
Objective: To evaluate the reduction/suppression of signs and symptoms of oral candidiasis in patients treated with head and neck RT, users of Vacucis or Placebo.
Read more
Material and method: Patients will receive information regarding the trial and, if they meet the inclusion criteria and agree to participate in it, they will sign the informed consent. All patients will be informed following the usual care practice of the characteristics of their candidiasis infection as well as the possibilities and alternatives of treatment and their respective efficacy.
A descriptive analysis of the sample in terms of prevalence will be carried out. Categorical variables will be described as frequency and percentage and continuous variables as mean and standard deviation or median and interquartile range depending on their adjustment to normality, which will be calculated with the Kolmogorov-Smirnov test. To study the effect of the vaccine on the evolution of candidiasis, the Chi-square test, Student's t test or the non-parametric Mann-Whitney test will be used. The association of prevalence with CFU in both groups will be analyzed using the ANOVA test. Those values of p < 0.05 will be considered significant.
Read the detailed description
The design of a randomized, randomized (test and placebo) triple-blind (patient, investigator and evaluator) clinical trial is proposed. The clinical trial will be carried out in accordance with the criteria recommended in the CONSORT Guidelines.
All patients who agree to participate will have a sample taken following the manufacturer's instructions for the design of the autovaccine, using a sterile swab that will be placed in transport medium (AMIES type) and sent to the laboratory. After 1 month of taking the sample, the laboratory that will be in possession of the randomization will damage the container/dispenser, which will be exactly the same in both groups T and P. Group T will be administered the complete autovaccine, while group P , the content will be the same except for the active ingredient, that is, only thimerosal, methylcellulose, sodium chloride and orange essence. In this way, neither the research group nor the patient himself will be known by the group to which he has been assigned.
In the event of unforeseen adverse effects, which are not expected, patients will be withdrawn from the study and treated according to standard care practice. All patients will be able to resort to rescue medication if the symptomatology is exacerbated during the follow-up period of the study, always under the prescription of the physician (nystatin aqueous rinse solution 1ml/100,000 IU or oral Fluconazole 50 mg/24 hours).
- Conditions
- Oral Candidiasis, Oral Candidiasis Recurrent, Radiotherapy; Complications, Candida Albicans Infection, Microbial Colonization, Xerostomia
- Being tested
- Vacucis autovaccine, Placebo
- Keywords
- oral candidiasis
- Medical subject headings
- Candidiasis, Oral, Communicable Diseases, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacucis autovaccineDrug
A sample will be taken from all participants in group T following the manufacturer's instructions for the design of the autovaccine, using a sterile swab that will be placed in a transport medium and sent to the laboratory. After 1 month from the sample collection, the laboratory will send in a container/dispenser (with the same appearance in both groups) to the T group will be administered the complete autovaccine ((with two applications per day for 7 weeks)
PlaceboDrug
A sample will be taken from all participants in group P following the manufacturer's instructions for the design of the autovaccine, using a sterile swab that will be placed in a transport medium and sent to the laboratory (as in group T). After 1 month from the collection of the sample, the laboratory will send it in a container/dispenser (with the same appearance in both groups). The content in group P will receive a placebo in the same dosage and temporality as group T, it will be the same except for the active ingredient, that is, only thimerosal, methylcellulose, sodium chloride and orange essence.
| Study group | Role | What they receive |
|---|---|---|
| Test group (T) | Active comparator | Group formed by those patients who will receive the drug to be tested Vacucis Receives: Drug: Vacucis autovaccine |
| Placebo control group (P) | Placebo comparator | Group formed by those patients who will receive placebo, in the same dosage and duration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of candidiasis
Mouth pain will be measured with the visual analog scale. It consists of a 10cm straight line with the words "No Pain" on the left end and "Worst Pain Imaginable" on the right end. Minimum value 0, maximum value 10. A value lower than 4 on the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value higher than 6 implies the presence of very severe pain.
Measured: 6 months
Oral signs of candidiasis
Prosthetic stomatitis will be evaluated according to Newton's clinical classification. Grade I: Reddish stippling. Grade II: Diffuse erythema. Grade III: Granular mucosa and non-neoplastic papillary hyperplasia.
Measured: 6 months
Modification of fungal growth
It will be evaluated with the microbiological study: the CFU (or colony forming units) will be studied in culture plates.
Measured: 6 months
Determination of quality of life
It will be assessed with the oral health impact profile (OHIP-14). This questionnaire includes seven dimensions with 14 items to determine the quality of life. The higher the average value of the seven dimensions, the more negative the impact of oral health on the quality of life of an individual.Minimum of 0 points and maximum of 56 points.
Measured: 6 months
Secondary outcomes (2)
Relationship between clinical signs and symptoms and saliva levels.
The patient's saliva will be quantified by salivometry using: TSG-I: basal global saliva rate and TSG-II: stimulated global saliva rate.
Measured: 6 months
Relationship between clinical signs and symptoms and xerostomia
The degree of xerostomia (subjective sensation) will be evaluated through the xerostomia inventory test (XI).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start30 Apr 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289375
- Sponsor's protocol ID
- RCT-VCA-22
- Status last verified
- Oct 2024
- First submitted
- 11 Feb 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Vacucis Candida® Autovaccine in the Management of Chronic Oral Candidiasis. Randomized Triple-blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05289375
- Acronym / sponsor ID
- RCT-VCA-22
- Conditions
- Oral Candidiasis, Oral Candidiasis Recurrent, Radiotherapy; Complications, Candida Albicans Infection, Microbial Colonization, Xerostomia
- Keywords
- oral candidiasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Oral candidiasis is an infectious disease caused by the growth of Candida colonies and their penetration into oral tissues when physical barriers and host defenses are weakened. It constitutes one of the most common pathologies within the field covered by Dentistry. Candida infections are found in at least 80% of AIDS patients and in a third of HIV infection cases. Systemic diseases such as diabetes and a wide pharmacological arsenal to which the general population is subjected, are other causes of the increase in the prevalence of this disease. In addition, the high prevalence of oral sequelae (hyposialia) in the population over 65 years of age, due to the specific characteristics of this age group, such as multiple pathologies and drug use, explains the presence of this disease in this segment. of the population One of the great difficulties for the study of this disease is the diversity of predisposing factors, which do nothing but throw greater confusion into the results of the different works.
Objective: To evaluate the reduction/suppression of signs and symptoms of oral candidiasis in patients treated with head and neck RT, users of Vacucis or Placebo.
Material and method: Patients will receive information regarding the trial and, if they meet the inclusion criteria and agree to participate in it, they will sign the informed consent. All patients will be informed following the usual care practice of the characteristics of their candidiasis infection as well as the possibilities and alternatives of treatment and their respective efficacy.
A descriptive analysis of the sample in terms of prevalence will be carried out. Categorical variables will be described as frequency and percentage and continuous variables as mean and standard deviation or median and interquartile range depending on their adjustment to normality, which will be calculated with the Kolmogorov-Smirnov test. To study the effect of the vaccine on the evolution of candidiasis, the Chi-square test, Student's t test or the non-parametric Mann-Whitney test will be used. The association of prevalence with CFU in both groups will be analyzed using the ANOVA test. Those values of p < 0.05 will be considered significant.
Detailed description
The design of a randomized, randomized (test and placebo) triple-blind (patient, investigator and evaluator) clinical trial is proposed. The clinical trial will be carried out in accordance with the criteria recommended in the CONSORT Guidelines.
All patients who agree to participate will have a sample taken following the manufacturer's instructions for the design of the autovaccine, using a sterile swab that will be placed in transport medium (AMIES type) and sent to the laboratory. After 1 month of taking the sample, the laboratory that will be in possession of the randomization will damage the container/dispenser, which will be exactly the same in both groups T and P. Group T will be administered the complete autovaccine, while group P , the content will be the same except for the active ingredient, that is, only thimerosal, methylcellulose, sodium chloride and orange essence. In this way, neither the research group nor the patient himself will be known by the group to which he has been assigned.
In the event of unforeseen adverse effects, which are not expected, patients will be withdrawn from the study and treated according to standard care practice. All patients will be able to resort to rescue medication if the symptomatology is exacerbated during the follow-up period of the study, always under the prescription of the physician (nystatin aqueous rinse solution 1ml/100,000 IU or oral Fluconazole 50 mg/24 hours).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group (T) | Active comparator | Drug: Vacucis autovaccineGroup formed by those patients who will receive the drug to be tested Vacucis |
| Placebo control group (P) | Placebo comparator | Drug: PlaceboGroup formed by those patients who will receive placebo, in the same dosage and duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacucis autovaccineA sample will be taken from all participants in group T following the manufacturer's instructions for the design of the autovaccine, using a sterile swab that will be placed in a transport medium and sent to the laboratory. After 1 month from the sample collection, the laboratory will send in a container/dispenser (with the same appearance in both groups) to the T group will be administered the complete autovaccine ((with two applications per day for 7 weeks) | Drug | Test group (T) |
| PlaceboA sample will be taken from all participants in group P following the manufacturer's instructions for the design of the autovaccine, using a sterile swab that will be placed in a transport medium and sent to the laboratory (as in group T). After 1 month from the collection of the sample, the laboratory will send it in a container/dispenser (with the same appearance in both groups). The content in group P will receive a placebo in the same dosage and temporality as group T, it will be the same except for the active ingredient, that is, only thimerosal, methylcellulose, sodium chloride and orange essence. | Drug | Placebo control group (P) |
Primary outcome
Symptoms of candidiasis
Time frame: 6 months
Mouth pain will be measured with the visual analog scale. It consists of a 10cm straight line with the words "No Pain" on the left end and "Worst Pain Imaginable" on the right end. Minimum value 0, maximum value 10. A value lower than 4 on the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value higher than 6 implies the presence of very severe pain.
Oral signs of candidiasis
Time frame: 6 months
Prosthetic stomatitis will be evaluated according to Newton's clinical classification. Grade I: Reddish stippling. Grade II: Diffuse erythema. Grade III: Granular mucosa and non-neoplastic papillary hyperplasia.
Modification of fungal growth
Time frame: 6 months
It will be evaluated with the microbiological study: the CFU (or colony forming units) will be studied in culture plates.
Determination of quality of life
Time frame: 6 months
It will be assessed with the oral health impact profile (OHIP-14). This questionnaire includes seven dimensions with 14 items to determine the quality of life. The higher the average value of the seven dimensions, the more negative the impact of oral health on the quality of life of an individual.Minimum of 0 points and maximum of 56 points.
2 secondary outcomes
Relationship between clinical signs and symptoms and saliva levels.
Time frame: 6 months
Relationship between clinical signs and symptoms and xerostomia
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: Undecided. We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
Related trials for Oral Candidiasis
RecruitingObservational study
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
RecruitingObservational study
Oropharyngeal Candidiasis (OPC) and S-ECC
Candida Infection, Oral Thrush
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Pérez-Sayáns, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacucis autovaccine in people with Oral Candidiasis and Oral Candidiasis Recurrent, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Pérez-Sayáns, PhD (626233504 ext. 0034, mario.perez@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of candidiasis (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.