Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

Zagazig University

Status and phase: Completed; Phase 2; Phase 1

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05326152

IRB# 6547/-25-11-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups, including a placebo group

IntralesionaL Hepatitis B vaccine

Experimental group

Description:

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

Treatment:

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

Intramuscular Hepatitis B vaccine

Experimental group

Description:

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.

Treatment:

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

Intralesional saline

Placebo Comparator group

Description:

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

Treatment:

Biological: Intralesional saline