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Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT05326152
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
11
Actual Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)
  • Biological: Intralesional saline
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Intralesional or Intramuscular Hepatitis B Vaccine Versus Intralesional Saline in the Treatment of Multiple Common Warts
Actual Study Start Date :
Nov 25, 2020
Actual Primary Completion Date :
Jun 20, 2021
Actual Study Completion Date :
Oct 25, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Immediate adverse effects [up to 20 minutes after intralesional or intramuscular injection of vaccine]

Secondary Outcome Measures

  1. 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.

  2. Late adverse effects [up to 6 months follow-up period]

  3. Recurrence [for 6 months-follow-up]

    after complete clearance of all warts

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zagazig university Zagazig Sharkia Egypt 44519

Sponsors and Collaborators

  • Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Basma Magdy Elkholy, MD, Clinical professor, Zagazig University
ClinicalTrials.gov Identifier:
NCT05326152
Other Study ID Numbers:
  • IRB# 6547/-25-11-2020
First Posted:
Apr 13, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Warts
Hepatitis

Study Results

No Results Posted as of Apr 13, 2022