Clinical trial NCT00569231: Study With Candida Antigen for Treatment of Warts
Official title: A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Warts
HPV
Keywords: Warts
Candida
HPV
Injections, Intralesional
Immune System
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Allermed Laboratories, Inc.
First posted: 2007-12-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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.

Detailed description: The use of recall antigens for treating warts is not yet Food and Drug Administration (FDA) approved. The primary goal of this work was to assess the safety of Candin as an investigational new drug (IND) for the treatment of warts. In addition, clinical resolution of treated and untreated warts was evaluated and immunologic responses were examined using an ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay in order to elucidate the immunologic mechanisms behind the successful regression of warts in patients undergoing Candin injection immunotherapy.

Eligibility criteria: Inclusion Criteria:

* Subjects must be ages 18-50.
* Female subjects of child-bearing potential must have a negative urine pregnancy test before each treatment.
* Female subjects of child-bearing potential agree to use a reliable form of birth- control as the risks associated with candida antigens during pregnancy are not known.
* Subjects must have two or more cutaneous, non-genital, non-facial warts.
* Subjects must be able to provide written, informed consent.
* Subjects must be willing to comply with the requirements of the protocol.
* Subjects vital signs must be within the following parameters at time of enrollment:

  * Blood Pressure - \<150/95 mmHg
  * Temperature - \<100.4° F
  * Pulse Rate - 50 to 100 beats/minute
  * Respiratory Rate - \<24 breaths/minute

Exclusion Criteria:

* Subjects who have a history of disease or treatment that has caused the subject to be immunosuppressed to include, but not limited to, cancer, HIV, or organ transplantation. Immunosuppression will be determined only by medical history.
* Subjects who are pregnant, lactating, or attempting to become pregnant, as the risks associated with candida antigens during pregnancy are not known.
* Subjects who have only genital or facial warts.
* Subjects who are unable to return for follow-up visits or comply with the protocol.
* Subjects who have a known allergy to Thimerosol or the candida antigen.
* Subjects who have a history of asthma as determined by a medical history or treatment for an asthmatic episode.
* Subjects who have any type of diabetes.
* Subjects who are currently using non-selective Beta Blockers.
* Subjects who are currently using H2 antagonists (e.g., cimetidine). There will be a 24 hour washout period for any use of H2 antagonists prior to beginning treatment in the study.
* Subjects who have a history of keloid formation.
* Subjects who have a history of alcohol or illicit drug abuse, as determined only by medical history.
* Subjects who have had previous treatment with candida antigens for their warts.
* Subjects who are currently using any other treatments for their warts. This includes prescription or over-the-counter medications. Subjects must have a wash¬out period of 30 days for any previous treatments prior to beginning the study.
* Subjects with a blood pressure \>150/95, temperature \>100.4° F, pulse rate \<50 or \>100 beats per minute, and respiratory rate \>24 at time of enrollment.

Primary outcomes:
measure: Number of Participants With Clinical Resolution of Injected Wart
timeFrame: Initial visit to completion of protocol, which is up to 30 weeks
Secondary outcomes:
measure: Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart
timeFrame: Initial visit to completion of protocol, which is up to 30 weeks
measure: Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart
timeFrame: Initial visit to completion of protocol, which is up to 30 weeks
Other outcomes:
measure: Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide
timeFrame: Initial visit to completion of protocol, which is up to 30 weeks
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Mayumi Nakagawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Majewski S, Jablonska S. Human papillomavirus-associated tumors of the skin and mucosa. J Am Acad Dermatol. 1997 May;36(5 Pt 1):659-85; quiz 686-8. doi: 10.1016/s0190-9622(97)80315-5.
citation: Baker GE, Tyring SK. Therapeutic approaches to papillomavirus infections. Dermatol Clin. 1997 Apr;15(2):331-40. doi: 10.1016/s0733-8635(05)70441-1.
citation: Miller DM, Brodell RT. Human papillomavirus infection: treatment options for warts. Am Fam Physician. 1996 Jan;53(1):135-43, 148-50.
citation: Quan MB, Moy RL. The role of human papillomavirus in carcinoma. J Am Acad Dermatol. 1991 Oct;25(4):698-705. doi: 10.1016/0190-9622(91)70256-2.
citation: Pfister H. Human papillomaviruses and skin cancer. Semin Cancer Biol. 1992 Oct;3(5):263-71.
citation: MASSING AM, EPSTEIN WL. Natural history of warts. A two-year study. Arch Dermatol. 1963 Mar;87:306-10. doi: 10.1001/archderm.1963.01590150022004. No abstract available.
citation: Johnson SM, Brodell RT. Treating warts: a review of therapeutic options. Consultant 1999;39(1):253-266.
citation: Brunk D. Injection of Candida antigen works on warts. Skin and Allergy News. 1999; 30(12):5.
citation: Johnson SM, Roberson PK, Horn TD. Intralesional injection of mumps or Candida skin test antigens: a novel immunotherapy for warts. Arch Dermatol. 2001 Apr;137(4):451-5.
citation: Horn TD, Johnson SM, Helm RM, Roberson PK. Intralesional immunotherapy of warts with mumps, Candida, and Trichophyton skin test antigens: a single-blinded, randomized, and controlled trial. Arch Dermatol. 2005 May;141(5):589-94. doi: 10.1001/archderm.141.5.589.
citation: Coleman HN, Greenfield WW, Stratton SL, Vaughn R, Kieber A, Moerman-Herzog AM, Spencer HJ, Hitt WC, Quick CM, Hutchins LF, Mackintosh SG, Edmondson RD, Erickson SW, Nakagawa M. Human papillomavirus type 16 viral load is decreased following a therapeutic vaccination. Cancer Immunol Immunother. 2016 May;65(5):563-73. doi: 10.1007/s00262-016-1821-x. Epub 2016 Mar 15.