Candida Vaccine for Head and Neck Cancer

Recruiting at 5 trial locations

Overseen By Madison Trujillo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arkansas

Disqualifiers: Pregnancy, Breastfeeding, Allergy to Candin, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2 years

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is the Candida Vaccine safe for use in humans?

The Candida albicans skin test antigen (CASTA) has been tested for safety in humans, showing that a 1-microgram dose is generally safe for use in skin tests, with only one adverse reaction reported in a person with specific allergies. Overall, the safety profile of this antigen compares well with other similar antigens used in testing. ^{1 2 3 4 5}

How does the Candida Vaccine treatment differ from other treatments for head and neck cancer?

The Candida Vaccine treatment, using Candin, is unique because it leverages the body's immune response to Candida albicans, a common yeast, to potentially boost immune function against cancer cells. Unlike traditional cancer treatments that directly target cancer cells, this approach aims to enhance the body's own immune system to fight the cancer. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Omar Atiq

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for adults over 18 with squamous cell carcinoma of the head and neck who've finished curative therapy within the last 120 days and currently show no signs of disease. Participants must be able to follow study procedures and give informed consent.

Inclusion Criteria

Willing and able to comply with the requirements of the protocol

My tests show no signs of cancer.

I completed treatment for head or neck cancer within the last 4 months.

Exclusion Criteria

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 2 weeks

1 visit (in-person)

Treatment

Participants receive 7 injections of Candin or placebo over a two-year period

2 years

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

Treatment Details

Interventions

• Candin

Trial Overview The study tests a vaccine called Candin, given in seven doses over two years, against a saline placebo to see if it can lower cancer recurrence rates. For every three participants receiving Candin, one will get the placebo.

Participant Groups

Group I: Candin vaccine Active Control 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Candin is already approved in United States for the following indications:

Approved in United States as CANDIN for:

• Assess cellular hypersensitivity to Candida albicans

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Highlands Oncology Group, PA

Collaborator

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Findings from Research

A new skin test antigen derived from Candida albicans (CASTA) was developed and found to be safe for use in skin tests, with only one notable adverse reaction in a highly sensitive individual out of the tested subjects.

In a study involving 40 healthy subjects, the CASTA skin test demonstrated a significant reactor rate of 50% at a 1-microgram dose, indicating its potential effectiveness in measuring cell-mediated immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel Candida albicans skin test antigen: efficacy and safety in man. Esch, RE., Buckley, CE.[2020]

Vaccination with the rAls3p-N candidate induced a broader antibody response compared to rAls1p-N and was equally effective against disseminated candidiasis in mice, indicating its potential as a strong vaccine candidate.

The rAls3p-N vaccine showed superior effectiveness against oropharyngeal and vaginal candidiasis compared to rAls1p-N, suggesting it may offer better protection for mucosal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the anti-Candida rAls3p-N or rAls1p-N vaccines against disseminated and mucosal candidiasis. Spellberg, BJ., Ibrahim, AS., Avanesian, V., et al.[2007]

The study developed a novel prostate cancer immunotherapy using peptides based on prostate-specific antigen, which showed promising immunogenic responses in 40% of prostate cancer patients tested.

The peptides were found to be soluble and did not affect the maturation of Langerhans cells, indicating a potential safe profile for further development in immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel prostate cancer immunotherapy using prostate-specific antigen peptides and Candida skin test reagent as an adjuvant. Abdallah, AO., Coleman, H., Kamel, M., et al.[2022]

Experimental vaccines against various fungal infections, including Coccidioides immitis and Candida albicans, have shown promise in eliciting both humoral and cell-mediated immunity, indicating their potential effectiveness in protecting against these infections.

Some vaccines, like the one for Histoplasma capsulatum, demonstrated a direct correlation between induced immunity and protection from infection, suggesting that these vaccines could be viable options for human use in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccines against fungal infections. Segal, E.[2004]

In a study of 60 head and neck cancer patients undergoing radiation therapy, the rate of oral Candida colonization significantly increased during and after treatment, with a detection rate of 56.7% during radiation and 63.3% post-radiation.

Candida albicans was the most commonly identified species among the patients, suggesting that radiation-induced oral mucositis may contribute to higher susceptibility to Candida infections in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral candida species distribution in patients receiving radiotherapy for head and neck cancer]. Zhang, YY., Li, AQ., Wang, NN., et al.[2018]

In guinea pigs, contact sensitivity to Candida albicans was successfully induced through patch testing, showing that even non-immune animals can develop a reaction after exposure, indicating a potential mechanism for delayed hypersensitivity.

In humans, a strong correlation was found between delayed hypersensitivity reactions to intradermally injected C. albicans antigen and positive patch-test reactions, suggesting that the Candida patch test could be a useful tool for assessing immune function in patients with skin disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact sensitivity to Candida albicans--comparative studies in man and animal (guinea-pig). Tagami, H., Urano-Suehisa, S., Hatchome, N.[2019]

In a study involving 100 individuals, the yeast cell suspension antigen showed a slightly higher positive response (69.0%) compared to the polysaccharide antigen (61.0%) in intradermal tests for delayed hypersensitivity to Candida albicans.

Despite the differences in positivity rates, there was a high concordance of 82.0% between the two antigens, suggesting that the polysaccharide antigen is also a viable option for testing immunological cellular competence against Candida albicans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Candidin: comparison of two antigens for cutaneous delayed hypersensitivity testing. Fava-Netto, C., Gambale, W., Croce, J., et al.[2019]

The study identifies that abnormal delayed-type hypersensitivity to Candida albicans is linked to specific circulating T cells, particularly CD8 cells, which can be detected through cell culture after intradermal injection of the antigen.

There is a strong correlation between clinical symptoms, skin tests, and lymphocyte activation tests, suggesting that these methods can help diagnose this difficult-to-detect immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis of delayed type hypersensitivity to Candida albicans. Evaluation of lymphocyte activation by flow cytometry (171 observations)]. Brunet, JL., Gozon, G., Sainte-Laudy, J., et al.[2017]

Vaccination with Candida albicans ribosomes successfully induced cell-mediated immunity (CMI) in mice and guinea pigs, as evidenced by delayed type hypersensitivity (DTH) reactions similar to those caused by live C. albicans.

In vitro tests showed that spleen lymphocytes from vaccinated mice were stimulated by the ribosomal antigen, confirming the ability of C. albicans ribosomes to activate immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell-mediated immunity following experimental vaccinations with Candida albicans ribosomes. Levy, R., Segal, E., Eylan, E., et al.[2019]

In four cases of chronic mucocutaneous candidiasis (CMCC), patients exhibited high levels of antibodies against candida, indicating an enhanced humoral immune response despite having depressed cellular immunity.

These patients were unable to mount delayed hypersensitivity reactions to candida and other antigens, suggesting a significant impairment in their cellular immune function, which was further evidenced by prolonged survival of skin homografts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic mucocutaneous candidiasis accompanied by enhanced antibody production. Takeya, K., Nomoto, K., Matsumoto, T., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

A novel Candida albicans skin test antigen: efficacy and safety in man. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the anti-Candida rAls3p-N or rAls1p-N vaccines against disseminated and mucosal candidiasis. [2007]

3. England pubmed.ncbi.nlm.nih.gov

A novel prostate cancer immunotherapy using prostate-specific antigen peptides and Candida skin test reagent as an adjuvant. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Vaccines against fungal infections. [2004]

5. China pubmed.ncbi.nlm.nih.gov

[Oral candida species distribution in patients receiving radiotherapy for head and neck cancer]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Contact sensitivity to Candida albicans--comparative studies in man and animal (guinea-pig). [2019]

7. Brazil pubmed.ncbi.nlm.nih.gov

Candidin: comparison of two antigens for cutaneous delayed hypersensitivity testing. [2019]

8. France pubmed.ncbi.nlm.nih.gov

[Diagnosis of delayed type hypersensitivity to Candida albicans. Evaluation of lymphocyte activation by flow cytometry (171 observations)]. [2017]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Cell-mediated immunity following experimental vaccinations with Candida albicans ribosomes. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Chronic mucocutaneous candidiasis accompanied by enhanced antibody production. [2020]