Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

Study Overview
=================
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.

Official Title
-----------------
Intralesional or Intramuscular Hepatitis B Vaccine Versus Intralesional Saline in the Treatment of Multiple Common Warts

Conditions
-----------------
Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts

Intervention / Treatment
-----------------
* Biological: hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)
* Biological: Intralesional saline


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IntralesionaL Hepatitis B vaccine<br>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 | Biological: hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)<br>* Randomized placebo-controlled comparative effectiveness clinical trial<br>|
| Experimental: Intramuscular Hepatitis B vaccine<br>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. | Biological: hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)<br>* Randomized placebo-controlled comparative effectiveness clinical trial<br>|
| Placebo Comparator: Intralesional saline<br>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 | Biological: Intralesional saline<br>* Intralesional saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 3 months after last injection | 
| Immediate adverse effects |  | up to 20 minutes after intralesional or intramuscular injection of vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 3 months | 
| Late adverse effects |  | up to 6 months follow-up period | 
| Recurrence | after complete clearance of all warts | for 6 months-follow-up |