Interleukin 4 and Interferon Gamma Predictors of Human Papillomavirus Immunotherapy in Warts

Completed

• Conditions: Wart, Genital; Warts Hand
• Interventions: Biological: IL-4 and IFN-γ measurements

• Registration Number: NCT05100043
• Lead Sponsor: Zagazig University

Brief Summary

In the present study the investigators assessed the invitro role of IL-4 and IFN-γ in predicting the response to bivalent HPV vaccine after whole blood stimulation

Detailed Description

40 Patients and 40 controls are enrolled in the study. Participants suffer from chronic recurrent cutaneous and genital warts. Blood samples were withdrawn then whole blood cultures are prepared. Cultures are stimulated with bivalent HPVvaccine. IL-4 and IFN-γ measurement in culture supernatants by ELISA. IL-4 and IFN-γ are investigated to predict the therapeutic response to bivalent HPV vaccine immunotherapy in warts.

Study Timeline

• Study Start: 2020-01-03
• Primary Completion: 2020-07-03
• Study Completion: 2021-03-02
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients with recurrent and recalcitrant cutaneous and anogenital warts.

Exclusion Criteria

• History of allergy to the HPV vaccine
• Active viral, fungal, or bacterial infections
• Immunosuppressive diseases or drugs.
• Autoimmune diseases, or other systemic diseases, e.g., hepatic, or renal disorders, diabetes, meningitis or convulsions
• Skin allergies
• Pregnancy and lactation
• Earlier wart treatment at least one month before enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	IL-4 and IFN-γ measurements	Patients having multiple recurrent and recalcitrant cutaneous and genital warts
Controls	IL-4 and IFN-γ measurements	Healthy volunteers matched for age and sex

Primary Outcome Measures

Name	Time	Method
Change of IFN-γ and IL-4 levels	48 hours	Quantitative measurement of IFN-γ and IL-4 in culture supernatants

Secondary Outcome Measures

Name	Time	Method
Change in the size of warts	6 months	Clinical observation and photographing of wart size

Trial Locations

Locations (1)

Zagazig University Faculty of Medicine; 🇪🇬 Zagazig, Sharkia, Egypt