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

April 2, 2026 updated by: University of Arkansas

A Phase II Clinical Trial of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group, PA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph T Beck, MD, FACP
      • Little Rock, Arkansas, United States, 72205
      • Rogers, Arkansas, United States, 75758
        • Recruiting
        • Highlands Oncology Group, PA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph T Beck, MD, FACP
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group, PA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph T Beck, MD, FACP
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Zujun Li, MD
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Zujun Li, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Candin vaccine
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
Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.
Placebo Comparator: Placebo
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)
Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Regularly throughout the study, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

NYU Langone Health
Highlands Oncology Group, PA

Investigators

  • Principal Investigator: Omar Atiq, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Estimated)

July 31, 2031

Study Completion (Estimated)

July 31, 2031

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 275695

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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