Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

Study Overview
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Brief Summary
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This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the Candin and the placebo arm. The ratio of the number of subjects who will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until 68 subjects are eligible for injection.

Detailed Description
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This is a Phase II study to evaluate the efficacy and safety of a therapeutic vaccine called Candin® (Nielsen Biosciences, San Diego, CA) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of Candin (0.5 mL per dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3 weeks until they receive 4 injections. Then, subjects will receive one injection every 3 months until they receive a total of 7 injections. Subjects will have 2 more visits approximately 6 months apart after the last injection. Immunological assessment T-cell repertoire analysis and by fluorescent activated cell sorter analysis (FACS) will be made at 4 time points (Visits 1, 5, 7, and 8). Stool and oral wash samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.

Official Title
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A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

Conditions
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Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
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* Biological: 0.5 mL Candin®/injection
* Other: Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent Male or female 18 years of age or older Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the previous 120 days. No Evidence of Disease (NED) based on clinical and/or radiographic evaluations Willing and able to comply with the requirements of the protocol Exclusion Criteria: Positive urine pregnancy test for women of childbearing potential Being pregnant or attempting to be pregnant with the period of study participation Women who are breast feeding or plan to breast feed within the period of study participation Patients who are allergic to Candin® If in the opinion of the PIs or other Investigators, it is not in the best interest of the patient to enter or continue in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Candin vaccine<br>Seven Candida (Candin). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given. | Biological: 0.5 mL Candin®/injection<br>* Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.<br>|
| Placebo Comparator: Placebo<br>Seven placebo injections (sterile 0.9% Normal Saline). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given. | Other: Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)<br>* Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of clinical efficacy | Studying the efficacy of Candida and the schedule in which this protocol specifically outlines the clinical response (i.e., reduced cancer recurrence rate) of subjects is the primary endpoint. | Through study completion, up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events | The secondary endpoints of this study is safety, and the AEs will be diligently recorded and reviewed. | Regularly throughout the study, up to 2 years |