A Phase 1/2 interventional study of hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India) and Intralesional saline in Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 10 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-04-13.
Sponsored by Zagazig University · Phase 1/2, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 75 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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)
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)
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
Randomized placebo-controlled comparative effectiveness clinical trial
Intralesional saline
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
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
Plan to share: Undecided
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Zagazig University