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

Summary

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 80 subjects are eligible for injection.

Detailed description

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.

Arms & interventions

• Biological0.5 mL Candin®/injection

  Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

• OtherPlacebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)

  Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

Outcome measures

Eligibility criteria