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

NCT ID: NCT05100043

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-03

Study Completion Date

2021-03-02

Brief Summary

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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

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 Blood samples were withdrawn then whole blood cultures are prepared.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

Conditions

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Warts Hand Wart, Genital

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Patients having multiple recurrent and recalcitrant cutaneous and genital warts

IL-4 and IFN-γ measurements

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Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants

Controls

Healthy volunteers matched for age and sex

IL-4 and IFN-γ measurements

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Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants

Interventions

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Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Noha M Hammad, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman Marei, MD, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, Zagazig University , Zagazig, Egypt

Locations

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Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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3140-23-10-2019

Identifier Type: -

Identifier Source: org_study_id

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