Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

NCT05326152 | Completed Phase 1

• 1 other identifier: IRB# 6547/-25-11-2020
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 3 months after last injection

• Immediate adverse effects

  up to 20 minutes after intralesional or intramuscular injection of vaccine

Secondary Outcomes (3)

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

  up to 3 months

• Late adverse effects

  up to 6 months follow-up period

• Recurrence

  for 6 months-follow-up

Study Arms (3)

IntralesionaL Hepatitis B vaccine

EXPERIMENTAL

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)

Intramuscular Hepatitis B vaccine

EXPERIMENTAL

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)

Intralesional saline

PLACEBO COMPARATOR

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

Interventions

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 Hepatitis B vaccine; Intramuscular Hepatitis B vaccine

Intralesional saline BIOLOGICAL

Intralesional saline

Intralesional saline

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Interventions

GeneVac B

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: April 13, 2022
• Study Start: November 25, 2020
• Primary Completion: June 20, 2021
• Study Completion: October 25, 2021
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

EG (1)