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

Sponsor

University of Arkansas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05952934

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 68 subjects are eligible for injection.

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of Head and Neck	Biological: 0.5 mL Candin®/injection Other: Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin.This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Each study site will received a separate randomization scheme, and the research pharmacy at each site will implement and maintain randomization schedule.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Assessment of clinical efficacy [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 Outcome Measures

Assessment of adverse events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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) within the previous 120 days.
No Evidence of Disease (NED) based on clinical and/or 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator: Omar Atiq, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT05952934

Other Study ID Numbers:

275695

First Posted:

Jul 19, 2023

Last Update Posted:

Jul 19, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Recurrence

Study Results

No Results Posted as of Jul 19, 2023