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

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT05100043
Collaborator
(none)
80
Enrollment
1
Location
13.9
Actual Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: IL-4 and IFN-γ measurements

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 Blood samples were withdrawn then whole blood cultures are prepared.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

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
IL-4 and IFN-γ as Immunologic Predictors of Response to HPV Immunotherapy in Warts
Actual Study Start Date :
Jan 3, 2020
Actual Primary Completion Date :
Jul 3, 2020
Actual Study Completion Date :
Mar 2, 2021

Arms and Interventions

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Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants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Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants

Outcome Measures

Primary Outcome Measures

  1. Change of IFN-γ and IL-4 levels [48 hours]

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

Secondary Outcome Measures

  1. Change in the size of warts [6 months]

    Clinical observation and photographing of wart size

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zagazig University Faculty of Medicine Zagazig Sharkia Egypt 44519

Sponsors and Collaborators

  • Zagazig University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noha M Hammad, MD, Principal investigator, Zagazig University
ClinicalTrials.gov Identifier:
NCT05100043
Other Study ID Numbers:
  • 3140-23-10-2019
First Posted:
Oct 29, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Warts
Condylomata Acuminata

Study Results

No Results Posted as of Nov 5, 2021