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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05100043
Other study ID # 3140-23-10-2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2020
Est. completion date March 2, 2021

Study information

Verified date November 2023
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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 Blood samples were withdrawn then whole blood cultures are prepared.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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 2, 2021
Est. primary completion date July 3, 2020
Accepts healthy volunteers
Gender All
Age group 36 Months and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-?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

Locations

Country Name City State
Egypt Zagazig University Faculty of Medicine Zagazig Sharkia

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of IFN-? and IL-4 levels Quantitative measurement of IFN-? and IL-4 in culture supernatants 48 hours
Secondary Change in the size of warts Clinical observation and photographing of wart size 6 months
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