Human Papilloma Virus, Infections
Conditions
Brief summary
This clinical study investigates the immunological effects of tuberculin purified protein derivative (TPPD) therapy in patients with anogenital warts (AGW) caused by human papillomavirus (HPV). Twelve AGW patients received intralesional TPPD injections (5 tuberculin units) once weekly for six weeks and were compared with twelve control patients. Tissue samples were collected at baseline and after two injections for immunohistochemical analysis of interferon-alpha (IFN-α) and interleukin-2 (IL-2) expression. Blood samples were collected at baseline and after six injections to measure serum levels of IFN-α and IL-2 using ELISA. The study aims to evaluate TPPD as a potential immunotherapeutic agent by assessing cytokine responses associated with AGW regression.
Detailed description
The research was conducted, in the STIs clinic at the Department of Dermatology and Venereology, Dr. Hasan Sadikin Hospital Bandung. The specimen was taken from 12 patients with AGW who have been previously treated with TPPD intralesional therapy, and 12 patients with AGW which not treated with TPPD as a control, from previous research titled which has received ethical clearance from Dr. Hasan Sadikin Hospital Bandung No. LB.02.01/X.6.5/291/2019. The research inclusion criteria include specimen taken from patient with HPV infection in the anogenital area who have previously demonstrated a response to a 2 TU (0.1 ml) intradermal PPD antigen injection on the left forearm, with a minimum induration of 5 mm observed within 48-72 hours, and patients who were 12 years of age or older. Exclusion criteria include specimen from patient with a history of severe hypersensitivity reactions, such as anaphylaxis, to PPD antigen; pregnant or breastfeeding women; or who have received any other AGW treatments in the two to three months prior; those with immunosuppressive conditions or those who are taking immunosuppressive medications; patients with a history of asthma or other allergic conditions, as well as those experiencing active infections or other systemic illnesses; and patients with a history of keloids or seizures. The PPD group received intralesional TPPD therapy, administering 5 TU (0,25 ml of PPD-2TU) to the largest AGW lesion once a week for six consecutive injections. The technique involved positioning the syringe needle parallel to the skin surface, with the bevel facing upward. Evaluation of IFN-α and IL-2 expression was performed on AGW tissue and serum samples from AGW patients in the TPPD-treated group, both before and after therapy. Tissue cytokine expression was assessed after the second injection (week 2), while serum cytokine levels were measured after the sixth injection (week 6)
Interventions
DRUGprotein purified derivative
tuberculin purified protein derivative with dose 5 tuberculin unit
Sponsors
National University of Malaysia
Universitas Padjadjaran
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with HPV infection in the anogenital area. * Prior positive response to a 2 TU (0.1 mL) intradermal PPD antigen injection on the left forearm, indicated by a minimum induration of 5 mm within 48-72 hours. * Age 12 years or older.
Exclusion criteria
* History of severe hypersensitivity reactions (e.g., anaphylaxis) to PPD antigen. * Pregnant or breastfeeding women. * Received any other AGW treatments within the past 2-3 months. * Immunosuppressive conditions or currently taking immunosuppressive medications. * History of asthma or other allergic conditions. * Presence of active infections or other systemic illnesses. * History of keloids or seizures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tissue IFN-α Expression in AGW Lesions (Measured by IHC) | Baseline and Week 2 | Quantification of IFN-α positive lymphocytes in anogenital wart (AGW) tissue samples using immunohistochemistry. The average number of IFN-α positive cells will be calculated from three high-power fields (400× magnification). |
| Change in Tissue IL-2 Expression in AGW Lesions (Measured by IHC) | Baseline and Week 2 | Quantification of IL-2 positive lymphocytes in AGW tissue samples using immunohistochemistry. Results are expressed as the mean number of positive cells across three high-power fields |
| Percentage Reduction in AGW Lesion Volume | Baseline to Week 6 | Lesion volume reduction calculated using the formula: \[(Baseline Volume - Volume at Week 6) / Baseline Volume\] × 100%. Therapeutic response will be classified as: No response: 0% reduction Minimal response: \<50% reduction Partial response: 50-99% reduction Complete response: 100% reduction |
| Change in Serum IFN-α Levels (Measured by ELISA) | Baseline and Week 6 | Concentration of IFN-α in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL. |
| Change in Serum IL-2 Levels (Measured by ELISA) | Baseline and Week 6 | Concentration of IL-2 in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL. |
Countries
Indonesia
Outcome results
None listed