Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common WartsPhase 1/2NCT05326152
Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts
A Phase 1/2 study testing hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India) and Intralesional saline in people with Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts, run by Zagazig University at 1 site in Egypt.
Trial summary
Assessment of the effectiveness of intralesional and intramuscular hepatitis B vaccine in treatment of multiple common warts. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts
- What is being tested?
- hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India) and Intralesional saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2020to 25 Oct 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India), Intralesional saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 salineBiological
Intralesional saline
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Biological: Intralesional saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months after last injection
Immediate adverse effects
Measured: 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
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.
Measured: up to 3 months
Late adverse effects
Measured: up to 6 months follow-up period
Recurrence
after complete clearance of all warts
Measured: for 6 months-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start25 Nov 2020
- Primary completion20 Jun 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common WartsStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Basma Magdy Elkholy, MD, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326152
- Sponsor's protocol ID
- IRB# 6547/-25-11-2020
- Status last verified
- Apr 2022
- First submitted
- 15 Feb 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional or Intramuscular Hepatitis B Vaccine Versus Intralesional Saline in the Treatment of Multiple Common Warts
- ClinicalTrials.gov ID
- NCT05326152
- Acronym / sponsor ID
- IRB# 6547/-25-11-2020
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IntralesionaL Hepatitis B vaccine | Experimental | Biological: hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)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 |
| Intramuscular Hepatitis B vaccine | Experimental | Biological: hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)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. |
| Intralesional saline | Placebo comparator | Biological: Intralesional saline0.2 ml of saline injected in the largest wart and repeated every 2 weeks till clearance of warts or for a maximum of 5 sessions |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | IntralesionaL Hepatitis B vaccine, Intramuscular Hepatitis B vaccine |
| Intralesional salineIntralesional saline | Biological | Intralesional saline |
Primary outcome
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.
Immediate adverse effects
Time frame: up to 20 minutes after intralesional or intramuscular injection of vaccine
3 secondary outcomes
Efficacy of intralesional versus intramuscular hepatitis B vaccine in distant wart response
Time frame: up to 3 months
Late adverse effects
Time frame: up to 6 months follow-up period
Recurrence
Time frame: for 6 months-follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India) and Intralesional saline in people with Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of intralesional versus intramuscular hepatitis B vaccine in the treatment of multiple common warts (time frame: up to 3 months after last injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.