search
Back to results

Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

Primary Purpose

Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)
Intralesional saline
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Zagazig university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

IntralesionaL Hepatitis B vaccine

Intramuscular Hepatitis B vaccine

Intralesional saline

Arm 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

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.

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

Outcomes

Primary Outcome Measures

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.
Immediate adverse effects

Secondary Outcome Measures

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.
Late adverse effects
Recurrence
after complete clearance of all warts

Full Information

First Posted
February 15, 2022
Last Updated
April 12, 2022
Sponsor
Zagazig University
search

1. Study Identification

Unique Protocol Identification Number
NCT05326152
Brief Title
Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts
Official Title
Intralesional or Intramuscular Hepatitis B Vaccine Versus Intralesional Saline in the Treatment of Multiple Common Warts
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IntralesionaL Hepatitis B vaccine
Arm Type
Experimental
Arm 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
Arm Title
Intramuscular Hepatitis B vaccine
Arm Type
Experimental
Arm 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.
Arm Title
Intralesional saline
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Biological
Intervention Name(s)
hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)
Intervention Description
Randomized placebo-controlled comparative effectiveness clinical trial
Intervention Type
Biological
Intervention Name(s)
Intralesional saline
Intervention Description
Intralesional saline
Primary Outcome Measure Information:
Title
Efficacy of intralesional versus intramuscular hepatitis B vaccine in the treatment of multiple common warts
Description
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
Title
Immediate adverse effects
Time Frame
up to 20 minutes after intralesional or intramuscular injection of vaccine
Secondary Outcome Measure Information:
Title
Efficacy of intralesional versus intramuscular hepatitis B vaccine in distant wart response
Description
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
Title
Late adverse effects
Time Frame
up to 6 months follow-up period
Title
Recurrence
Description
after complete clearance of all warts
Time Frame
for 6 months-follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Zagazig university
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

We'll reach out to this number within 24 hrs