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NCT Number: NCT05100043

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

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

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Key information

Conditions

Warts Hand Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Wart, Genital Warts

Age range

36 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

About this study

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 Blood samples were withdrawn then whole blood cultures are prepared.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IL-4 and IFN-γ measurements

Biological

Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants

Primary outcomes

  1. Change of IFN-γ and IL-4 levels

    Time frame: 48 hours

    Quantitative measurement of IFN-γ and IL-4 in culture supernatants

Secondary outcomes

  1. Change in the size of warts

    Time frame: 6 months

    Clinical observation and photographing of wart size

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

IL-4 and IFN-γ As Immunologic Predictors of Response to HPV Immunotherapy in Warts

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 29, 2021
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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