Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

April 12, 2022 updated by: Basma Magdy Elkholy, MD, Zagazig University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: hepatitis 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
Experimental: 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.
Biological: hepatitis 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
Placebo Comparator: 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
Biological: Intralesional saline
Intralesional saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3 months after last injection
Immediate adverse effects
Time Frame: up to 20 minutes after intralesional or intramuscular injection of vaccine
up to 20 minutes after intralesional or intramuscular injection of vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3 months
Late adverse effects
Time Frame: up to 6 months follow-up period
up to 6 months follow-up period
Recurrence
Time Frame: for 6 months-follow-up
after complete clearance of all warts
for 6 months-follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2020

Primary Completion (Actual)

June 20, 2021

Study Completion (Actual)

October 25, 2021

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 6547/-25-11-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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