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Cancer Vaccine
Candida Antigen for Warts
Phase 1
Waitlist Available
Led By Mayumi Nakagawa, MD, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial visit to completion of protocol, which is up to 30 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
The purpose of this study is to look at how people respond to the treatment of warts through use of the Candida antigen to get an immune response to rid the body of human papillomavirus (HPV). The immune system is the part of the body that fights infections like HPV which causes warts. This research study will examine the response of your wart when injected with a portion of a common yeast (candida) which is the study drug. Your immune system response will also be looked at by doing a test called an ELISPOT assay. This test is done on blood samples. The results of this test may help us to determine how the Candida antigen affects your wart.
Eligible Conditions
- Warts
- Human Papillomavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initial visit to completion of protocol, which is up to 30 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial visit to completion of protocol, which is up to 30 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Clinical Resolution of Injected Wart
Secondary study objectives
Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart
Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart
Other study objectives
Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide
Side effects data
From 2010 Phase 1 trial • 18 Patients • NCT0056923183%
Injection site reaction
17%
Pain in extremity
11%
Muscle weakness
11%
Headache
11%
Flu like symptoms
6%
Lymph node pain
6%
Hematoma
6%
Rash
6%
Malaise
6%
Chills
6%
Hypertension
6%
Laryngeal inflammation
6%
Bullous dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Candida Antigen
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Candida AntigenExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Candida albicans
FDA approved
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
495 Previous Clinical Trials
150,246 Total Patients Enrolled
Allermed Laboratories, Inc.Industry Sponsor
Mayumi Nakagawa, MD, PhDPrincipal InvestigatorUniversity of Arkansas
1 Previous Clinical Trials
52 Total Patients Enrolled
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