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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment100 people
  • Recruiting US sites6
  • SponsorUniversity of Arkansas
  • RegistryNCT05952934

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence: a one-minute explainerNCT059529341 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to 100 Years
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Candida albicans antigen injection. An injectable formulation composed of antigens derived from the culture filtrate and cells of two different strains of Candida albicans (C. albicans), with immunomodulatory activity. Upon intralesional administration into the cutaneous human papilloma virus (HPV)-infected warts, the C. albicans antigens stimulate the immune system to mount a cytotoxic T-lymphocyte (CTL)-mediated immune response against the injected antigens and cause a delayed type hypersensitivity response against other local antigens, including antigens within the wart tissue. This leads to the production of Th1 cytokines, and the activation of natural killer (NK) cell- and CTL- mediated killing of HPV-infected cells. This causes clearing of both local and distant warts, and prevents both HPV infection and wart formation that results from HPV infection. NCI Drug Dictionary

Treatments listed in the registry

  • 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.

The study

Treatment groups

Randomized · Parallel · masking: Triple

Candin vaccine (Active Comparator)

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 (Placebo Comparator)

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.

Goals

What the study measures

Main goals

  • Assessment of clinical efficacy (Through study completion, up to 2 years)

Other goals

  • Assessment of adverse events

Planned enrollment: 100 (estimated).

Where

Recruiting US sites

  • Highlands Oncology Group, PA, Fayetteville, Arkansas
  • University of Arkansas for Medical Sciences, Little Rock, Arkansas
  • Highlands Oncology Group, PA, Rogers, Arkansas
  • Highlands Oncology Group, PA, Springdale, Arkansas
  • Perlmutter Cancer Center at NYU Langone Health, Mineola, New York
  • Perlmutter Cancer Center at NYU Langone Health, New York, New York

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 14, 2026. Public record; not medical advice.

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