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Completed

NCT Number: NCT05326152

Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

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

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Key information

Conditions

Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zagazig university

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

Randomized placebo-controlled comparative effectiveness clinical trial

Intralesional saline

Biological

Intralesional saline

Primary outcomes

  1. 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.

  2. Immediate adverse effects

    Time frame: up to 20 minutes after intralesional or intramuscular injection of vaccine

Secondary outcomes

  1. Efficacy of intralesional versus intramuscular hepatitis B vaccine in distant wart response

    Time frame: 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.

  2. Late adverse effects

    Time frame: up to 6 months follow-up period

  3. Recurrence

    Time frame: for 6 months-follow-up

    after complete clearance of all warts

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2022
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.