Intralesional or Intramuscular Hepatitis B Vaccine Versus Intralesional Saline in the Treatment of Multiple Common Warts
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Immediate adverse effects
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 10 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India) (Biological)
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.
Intervention: hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India) (Biological)
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
Intervention: Intralesional saline (Biological)
Outcomes
Primary Outcomes
Immediate adverse effects
Time Frame: up to 20 minutes after intralesional or intramuscular injection of vaccine
Efficacy of intralesional versus intramuscular hepatitis B vaccine in the treatment of multiple common warts
Time Frame: 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.
Secondary Outcomes
- Efficacy of intralesional versus intramuscular hepatitis B vaccine in distant wart response(up to 3 months)
- Late adverse effects(up to 6 months follow-up period)
- Recurrence(for 6 months-follow-up)
Investigators
Basma Magdy Elkholy, MD
Clinical professor
Zagazig University