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Skin Diseases, Infectious

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Immunomodulating Agents

Intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.

Candida Antigen

Mayumi Nakagawa, MD, PhD

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.

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.

Study With Candida Antigen for Treatment of Warts

A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen

Immunologic responses from peripheral blood mononuclear cells collected prior to vaccination and post-vaccination were measured by ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay to human papillomavirus type 57 L1-peptide.

When the participant completed the protocol, clinical resolution of the injected wart was determined by the overall percentage of resolution from the initial visit. Participants were classified as 'complete responders' if they had complete resolution of the injected wart, 'partial responders' if the injected wart regressed between 25% and 99%, and 'non-responders' if they had not achieved at least 25% regression of the injected wart.

When the participant completed the protocol, clinical resolution of 1st anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.

When the participant completed the protocol, clinical resolution of 2nd anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.

Allermed Laboratories, Inc.

University of Arkansas

Mayumi Nakagawa

All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Complete responder

Partial responder

Non-responder

The participants were analyzed if they completed the protocol by achieving complete resolution of the treated wart, receiving the maximum of 10 treatments, or by having less than 25% resolution of the treated wart after 5 treatments.

Number of Participants With Clinical Resolution of Injected Wart

Complete resolution of 1st non-injected wart

Partial resolution of 1st non-injected wart

Participants with 1st anatomically distant, non-injected wart were analyzed.

Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart

The participants with 2nd anatomically distant, non-injected wart were analyzed.

Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart

The interferon-γ enzyme-linked immunospot assay was performed on available samples from participants who completed the study.

Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide

Overall Study

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunologic Factors

ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intratumoral injection every second week for 8 weeks. Patients that do not progress will be offered continued treatment until complete response, confirmed progressive disease, or clinical deterioration.

ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intravenous infusion every second week until complete response, confirmed progressive disease, or clinical deterioration.

Agonistic human monoclonal IgG1 anti-CD40 antibody

ADC-1013

Per Norlén, MD, PhD

Dorte Nielsen, MD, PhD

The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors.

ADC-1013 First-in-Human Study

A First-in-human, Multicenter, Open-label, Multiple Ascending Dose Phase I Study in Patients With Advanced Solid Tumors to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intratumorally or Intravenously Administered ADC-1013

Dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended Phase 2 dose of ADC-1013 administered intratumorally or intravenously will be defined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study With Candida Antigen for Treatment of Warts	NCT00569231	Warts HPV	Candida Antigen	18 Years - 50 Years	University of Arkansas
ADC-1013 First-in-Human Study	NCT02379741	Neoplasms Solid Tumors	ADC-1013	18 Years -	Alligator Bioscience AB

Spots Global Cancer Trial Database for injections, intralesional