Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

Phase 1

Completed

• Conditions: Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts
• Interventions: Biological: Intralesional saline; Biological: hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)

• Registration Number: NCT05326152
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2020-11-25
• Primary Completion: 2021-06-20
• Study Completion: 2021-10-25
• Study First Submitted: 2022-02-15
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-12
• Last Update Submitted: 2022-04-12
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intralesional saline	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
IntralesionaL Hepatitis B vaccine	hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)	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
Intramuscular Hepatitis B vaccine	hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of intralesional versus intramuscular hepatitis B vaccine in the treatment of multiple common warts	up to 3 months after last injection	Percentage of patients showing complete response to intralesional hepatitis B vaccine and intramuscular hepatitis B vaccine.; Complete response: complete disappearance of warts including distant warts and complete return of normal skin markings (100%).; Partial response: if the warts have regressed in size by 50-99%. No response: less than 50% decrease in wart size.
Immediate adverse effects	up to 20 minutes after intralesional or intramuscular injection of vaccine

Secondary Outcome Measures

Name	Time	Method
Recurrence	for 6 months-follow-up	after complete clearance of all warts
Efficacy of intralesional versus intramuscular hepatitis B vaccine in distant wart response	up to 3 months	Percentage of patients showing complete response of their distant warts to intralesional hepatitis B vaccine and intramuscular hepatitis B vaccine.; Complete response: complete disappearance of distant warts and complete return of normal skin markings (100%).; Partial response: if the distant warts have regressed in size by 50-99%. No response: less than 50% decrease in distant wart size.
Late adverse effects	up to 6 months follow-up period

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Sharkia, Egypt