Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

Zagazig University75 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts

Interventions

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

Randomized placebo-controlled comparative effectiveness clinical trial

Intralesional salineBIOLOGICAL

Intralesional saline

Eligibility

Sex: ALLMin age: 10 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zagazig university

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

Efficacy of intralesional versus intramuscular hepatitis B vaccine in the treatment of multiple common warts

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.

Time frame: up to 3 months after last injection

Immediate adverse effects

Time frame: up to 20 minutes after intralesional or intramuscular injection of vaccine

Secondary Outcomes

Efficacy of intralesional versus intramuscular hepatitis B vaccine in distant wart response

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.

Time frame: up to 3 months

Late adverse effects

Time frame: up to 6 months follow-up period

Recurrence

after complete clearance of all warts

Time frame: for 6 months-follow-up

Data from ClinicalTrials.gov

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