Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts
Conditions
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.
Interventions
BIOLOGICALhepatitis 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
BIOLOGICALIntralesional saline
Intralesional saline
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Recurrence | for 6 months-follow-up | after complete clearance of all warts |
Countries
Egypt
Outcome results
None listed