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

November 12, 2023 updated by: Noha M Hammad, MD, Zagazig University

IL-4 and IFN-γ as Immunologic Predictors of Response to HPV 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Blood samples were withdrawn then whole blood cultures are prepared.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

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients are attendants in Zagazig University Hospitals Dermatology outpatient clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of IFN-γ and IL-4 levels
Time Frame: 48 hours
Quantitative measurement of IFN-γ and IL-4 in culture supernatants
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the size of warts
Time Frame: 6 months
Clinical observation and photographing of wart size
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Study Director: Ayman Marei, MD, PhD, Faculty of Medicine, Zagazig University , Zagazig, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2020

Primary Completion (Actual)

July 3, 2020

Study Completion (Actual)

March 2, 2021

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3140-23-10-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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