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NCT Number: NCT05952934

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

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.

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Key information

Conditions

Squamous Cell Carcinoma of Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Highlands Oncology Group, PA, Fayetteville, Arkansas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and/or immunotherapy) within the 120 days prior to the screening visit
  • No Evidence of Disease (NED) based on clinical and 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

Treatment and study plan

0.5 mL Candin®/injection

Biological

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

Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)

Other

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

Primary outcomes

  1. Assessment of clinical efficacy

    Time frame: Through study completion, up to 2 years

    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.

Secondary outcomes

  1. Assessment of adverse events

    Time frame: Regularly throughout the study, up to 2 years

    The secondary endpoints of this study is safety, and the AEs will be diligently recorded and reviewed.

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron Holley

CONTACT

[email protected]

501-686-8274

Madison Trujillo

CONTACT

[email protected]

501-686-8274

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Highlands Oncology Group, PA
  • NYU Langone Health

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Jul 19, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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