Study on Candida Vaccine to Prevent Cancer from Returning in Head and Neck Cancer Patients
Sponsor: University of Arkansas
ClinicalTrials ID:NCT05952934
This clinical trial is testing a vaccine called Candin to see if it can help prevent head and neck cancer from coming back. The study will compare the effects of the vaccine to a placebo over two years.
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Program Overview
This study is testing a vaccine called Candin to see if it can help prevent head and neck cancer from returning. Participants will receive a total of 7 injections over two years. The study will compare the cancer recurrence rates between those who receive the vaccine and those who receive a placebo. The study involves 68 participants, with 3 out of every 4 receiving the vaccine and the rest receiving a placebo.
Description
This clinical trial is designed to test the effectiveness and safety of a vaccine called Candin in adults who have had head and neck cancer. The study will last for two years, during which participants will receive 7 injections of either the Candin vaccine or a placebo (a harmless saline solution). The injections will be given in a specific schedule: one injection every 3 weeks for the first 4 doses, followed by one injection every 3 months for the remaining 3 doses. Participants will also have two additional follow-up visits about 6 months apart after the last injection.
Throughout the study, researchers will monitor the participants' immune responses and collect samples to analyze the diversity of bacteria in the body. This will help them understand how the vaccine affects the immune system and whether it can reduce the chances of cancer coming back.
Eligibility Criteria
Inclusion Criteria
- Able to provide informed consent
- Male or female, 18 years or older
- Have had squamous cell carcinoma of the head and neck and completed treatment (surgery, radiation, or chemotherapy) within the last 120 days
- No signs of cancer based on medical evaluations
- Willing and able to follow the study requirements
Exclusion Criteria
- Positive pregnancy test for women who can become pregnant
- Currently pregnant or planning to become pregnant during the study
- Breastfeeding or planning to breastfeed during the study
- Allergic to the Candin vaccine
- If the study doctors believe it is not in the best interest of the patient to participate
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