Recruiting
Phase 2

Candida Vaccine

Sponsor:

University of Arkansas

Code:

NCT05952934

Conditions

Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

0.5 mL Candin®/injection

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

Study Details

Brief 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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Study ID

NCT05952934

Start date

Feb 12, 2024

Status verified date

Sep, 2026

Completion date

Jul 31, 2032

Anticipated

Primary completion date

Jul 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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: 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.

Primary outcome measure

  • Assessment of clinical efficacy [ Time Frame: Through study completion, up to 2 years ]

Central Contacts and Locations

Central contacts

Madison Trujillo

501-686-8274MTrujillo@uams.edu

Aaron Holley

501-686-8274jaholley@uams.edu

Locations

Highlands Oncology Group, PA

Recruiting

Fayetteville, Arkansas, United States, 72762

Contacts

Jennifer Worth

479-872-8130Jworth@hogonc.com

Amy Purcell

479-872-8130apurcell@hogonc.com

Principal Investigator:

Joseph T Beck, MD, FACP

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Madison Trujillo

MTrujillo@uams.edu

Aaron Holley

JAHolley@uams.edu

Highlands Oncology Group, PA

Recruiting

Rogers, Arkansas, United States, 75758

Contacts

Jennifer Worth

479-872-8130Jworth@hogonc.com

Amy Purcell

479-872-8130apurcell@hogonc.com

Principal Investigator:

Joseph T Beck, MD, FACP

Highlands Oncology Group, PA

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Jennifer Worth

479-872-8130Jworth@hogonc.com

Amy Purcell

479-872-8130apurcell@hogonc.com

Principal Investigator:

Joseph T Beck, MD, FACP

Perlmutter Cancer Center at NYU Langone Health

Recruiting

Mineola, New York, United States, 11501

Contacts

Zujun Li, MD

(212) 731-6465Zujun.li@nyulangone.org

NYU Langone Health

ct.gov@nyulangone.org

Principal Investigator:

Zujun Li, MD

Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Zujun Li, MD

(212) 731-6465Zujun.li@nyulangone.org

NYU Langone Health

ct.gov@nyulangone.org

Principal Investigator:

Zujun Li, MD

More Information

Sponsor

University of Arkansas

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.