Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

NCT ID: NCT05326152

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2021-10-25

Brief Summary

Assessment of the effectiveness of intralesional and intramuscular hepatitis B vaccine in treatment of multiple common warts.

Detailed Description

Recently, intralesional immunotherapy by different antigens, including Candida antigen and purified protein derivative PPD has been proved effective in the treatment of different types of warts. Hepatitis B vaccine is one of the DNA vaccines that are regarded as being potentially safer, relatively cheap and easy to produce with no special storage requirements because they are extremely stable and allow for potential simultaneous immunization against multiple antigens or pathogens via co-expression of multiple epitopes on single plasmid. Hepatitis B vaccine could be a promising immunotherapeutic vaccine in the field of intralesional immunotherapy of warts. Moreover, the efficacy of intramuscular injection of hepatitis B vaccine would be assessed and compared to its intralesional injection.

Conditions

Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IntralesionaL Hepatitis B vaccine

0.2 ml of hepatitis B vaccine injected in the largest wart and repeated every 2 weeks till clearance of warts or for a maximum of 5 sessions

Group Type: EXPERIMENTAL

hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)

Intervention Type: BIOLOGICAL

Randomized placebo-controlled comparative effectiveness clinical trial

Intramuscular Hepatitis B vaccine

0.5 ml injected in the deltoid muscle for those who were younger than 19 years at the time of study and 1 ml for those who were 20 years and older at the time of study.

Three injections were done at 0, 1, and 4 months.

Group Type: EXPERIMENTAL

hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)

Intervention Type: BIOLOGICAL

Randomized placebo-controlled comparative effectiveness clinical trial

Intralesional saline

0.2 ml of saline injected in the largest wart and repeated every 2 weeks till clearance of warts or for a maximum of 5 sessions

Group Type: PLACEBO_COMPARATOR

Intralesional saline

Intervention Type: BIOLOGICAL

Intralesional saline

Interventions

hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)

Randomized placebo-controlled comparative effectiveness clinical trial

Intervention Type: BIOLOGICAL

Intralesional saline

Intralesional saline

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Adult patients of both sexes with multiple (> 3 warts) common warts of various sites, sizes and duration, with or without distant warts after taking informed consent from all patients

Exclusion Criteria

• Pregnancy or lactation.
• Serious systemic or anaphylactic reaction to a prior dose of the vaccine or to any of its components.
• Allergic skin disorders such as generalized eczema and urticaria.
• Moderate or severe acute illness with or without fever.
• Previous wart therapy within 1 month prior to the study.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Basma Magdy Elkholy, MD

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig university

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

IRB# 6547/-25-11-2020

Identifier Type: -

Identifier Source: org_study_id