Human Papilloma VirusNCT05761002
Human Papilloma Virus Genotypes and Treatment Outcomes of Intralesional Immunotherapy of Anogenital Warts
A study testing the Quadrivalent Vaccine (Gardasil) in people with Human Papilloma Virus and Anogenital Wart, run by Zagazig University at 1 site in Egypt.
Trial summary
This study aims to investigate the relationship between HPV genotypes and treatment outcomes of intralesional immunotherapy of anogenital warts with the quadrivalent vaccine (Gardasil). Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Human Papilloma Virus, Anogenital Wart
- What is being tested?
- the Quadrivalent Vaccine (Gardasil)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Jul 2023
- Phase
- Interventional
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with clinically diagnosed multiple anogenital warts who had not received treatment in the last 2 months before the study
Who cannot join
- Patient refusal, pregnancy, lactation, age less than 10 years, and immunosuppressive conditions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Rana Ehab
Zagazig, 44519
rana ehab, md, 01000896453, ranaehab015@gmail.com
About this study
This study aims to investigate the relationship between HPV genotypes and treatment outcomes of intralesional immunotherapy of anogenital warts with the quadrivalent vaccine (Gardasil).
Read the detailed description
Human papillomavirus (HPV), a member of the Papillomaviridae family, is a small, icosahedral, non-enveloped virus with a circular double-stranded DNA genome. Sexually transmitted HPV, which mainly infects mucosal and keratinized epithelium, has a cytopathic effect on the epithelium. Genital mucosal HPV infection is persistent and multifocal and can be subclinical (Alacam \& Bakir, 2021). Infection with HPV causes a large proportion of cervical, vaginal, vulvar, anal, and penile cancers, as well as genital warts (Choi, 2019).
Anogenital warts are common benign dermatological conditions caused by different HPV genotypes, with serotypes 6, 11, 16, and 18 being the most causative types (Santos-López et al., 2015). Their prevalence varies according to geographical locations. Data is not yet available on the HPV burden in the general population of Egypt (Elazab et al., 2021). In October 2014, a very important multicenter observational study in Egypt concluded that the prevalence of HPV among Egyptian women aged 18 years or more is about 10.4%, with the highest prevalence of HPV infection being observed among women aged 45-54 years (Shaltout et al., 2014).
Different modalities are available for the treatment of warts, such as topical podophyllin, imiquimod, podophyllotoxin, or trichloroacetic acid, surgical excision, electrosurgery, cryosurgery, laser surgery, and intralesional immunotherapy (Gill, 2021; Nofal et al., 2022). Available treatments are time-consuming, painful, and can leave scars or hypopigmentation. Furthermore, recurrence rates after any treatment range from 6% to 100% (Ciccarese et al., 2019). As a result, there has been a demand for safer modalities to treat recalcitrant warts. Immunotherapy presents an alternative approach to the management of warts as it provides ease of application, but even distant lesions get resolved with application to a single lesion. Immunotherapy has been performed with imiquimod, BCG vaccine, HPV vaccines, and auto implantation therapy (Gill, 2021).
Three HPV vaccines are licensed as protective measures against the development of genital warts, cervical cancer, and other anogenital cancers. They include the bivalent vaccine targeting serotypes 16/18 (Cervarix), the quadrivalent vaccine targeting serotypes 6/11/16/18 (Gardasil), and the nonavalent vaccine targeting serotypes 6/11/16/18/31/33/45/52/58 (Gardasil-9) (Vaccine Information Statement | HPV | VIS | CDC, 2021). There is a strong immune response against the HPV vaccine that not only causes the clearance of local wart lesions but also causes the clearance of distant lesions. The vaccine is designed to elicit neutralizing antibody responses which prevent initial infection with HPV, but in warts it mainly acts by mounting cell-mediated and humoral responses which help in the clearance of warts. The quadrivalent HPV vaccine contains inactive L1 proteins from four different strains: 6, 11, 16, and 18; synthesized in the yeast Saccharomyces cerevisiae (Gill, 2021).
- Conditions
- Human Papilloma Virus, Anogenital Wart
- Being tested
- the Quadrivalent Vaccine (Gardasil)
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Quadrivalent Vaccine (Gardasil)Biological
- Intralesional injection of the quadrivalent HPV vaccine (Gardasil) at a dose of 0.5ml, into the largest wart at 4-week intervals until complete clearance is achieved or for a maximum of three sessions.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | All patients will be subjected to:
* A thorough history taking and proper dermatological examination.
* Skin sampling from anogenital wart lesions: skin sterilization followed by injection of local anesthesia at the base of lesions, then the part of wart above skin surface will be removed using shave biopsy technique.
* DNA extraction of skin samples.
* Conventional PCR for low-risk HPV genotypes (6,11) and RT-PCR for high-risk HPV genotypes.
* Intralesional injection of the quadrivalent HPV vaccine (Gardasil) at a dose of 0.5ml, into the largest wart at 4-week intervals until complete clearance is achieved or for a maximum of three sessions. Receives: Biological: the Quadrivalent Vaccine (Gardasil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of lesion
The response will be considered complete if there is disappearance of the warts, partial if the warts regressed in size by 50-99% and no response if there is 0-49% decrease in wart size.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rana Ehab, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761002
- Sponsor's protocol ID
- 94412022
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papilloma Virus Genotypes and Treatment Outcomes of Intralesional Immunotherapy of Anogenital Warts
- ClinicalTrials.gov ID
- NCT05761002
- Acronym / sponsor ID
- 94412022
- Conditions
- Human Papilloma Virus, Anogenital Wart
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 9 Mar 2023 (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.
This study aims to investigate the relationship between HPV genotypes and treatment outcomes of intralesional immunotherapy of anogenital warts with the quadrivalent vaccine (Gardasil).
Detailed description
Human papillomavirus (HPV), a member of the Papillomaviridae family, is a small, icosahedral, non-enveloped virus with a circular double-stranded DNA genome. Sexually transmitted HPV, which mainly infects mucosal and keratinized epithelium, has a cytopathic effect on the epithelium. Genital mucosal HPV infection is persistent and multifocal and can be subclinical (Alacam \& Bakir, 2021). Infection with HPV causes a large proportion of cervical, vaginal, vulvar, anal, and penile cancers, as well as genital warts (Choi, 2019).
Anogenital warts are common benign dermatological conditions caused by different HPV genotypes, with serotypes 6, 11, 16, and 18 being the most causative types (Santos-López et al., 2015). Their prevalence varies according to geographical locations. Data is not yet available on the HPV burden in the general population of Egypt (Elazab et al., 2021). In October 2014, a very important multicenter observational study in Egypt concluded that the prevalence of HPV among Egyptian women aged 18 years or more is about 10.4%, with the highest prevalence of HPV infection being observed among women aged 45-54 years (Shaltout et al., 2014).
Different modalities are available for the treatment of warts, such as topical podophyllin, imiquimod, podophyllotoxin, or trichloroacetic acid, surgical excision, electrosurgery, cryosurgery, laser surgery, and intralesional immunotherapy (Gill, 2021; Nofal et al., 2022). Available treatments are time-consuming, painful, and can leave scars or hypopigmentation. Furthermore, recurrence rates after any treatment range from 6% to 100% (Ciccarese et al., 2019). As a result, there has been a demand for safer modalities to treat recalcitrant warts. Immunotherapy presents an alternative approach to the management of warts as it provides ease of application, but even distant lesions get resolved with application to a single lesion. Immunotherapy has been performed with imiquimod, BCG vaccine, HPV vaccines, and auto implantation therapy (Gill, 2021).
Three HPV vaccines are licensed as protective measures against the development of genital warts, cervical cancer, and other anogenital cancers. They include the bivalent vaccine targeting serotypes 16/18 (Cervarix), the quadrivalent vaccine targeting serotypes 6/11/16/18 (Gardasil), and the nonavalent vaccine targeting serotypes 6/11/16/18/31/33/45/52/58 (Gardasil-9) (Vaccine Information Statement | HPV | VIS | CDC, 2021). There is a strong immune response against the HPV vaccine that not only causes the clearance of local wart lesions but also causes the clearance of distant lesions. The vaccine is designed to elicit neutralizing antibody responses which prevent initial infection with HPV, but in warts it mainly acts by mounting cell-mediated and humoral responses which help in the clearance of warts. The quadrivalent HPV vaccine contains inactive L1 proteins from four different strains: 6, 11, 16, and 18; synthesized in the yeast Saccharomyces cerevisiae (Gill, 2021).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Biological: the Quadrivalent Vaccine (Gardasil)All patients will be subjected to: * A thorough history taking and proper dermatological examination. * Skin sampling from anogenital wart lesions: skin sterilization followed by injection of local anesthesia at the base of lesions, then the part of wart above skin surface will be removed using shave biopsy technique. * DNA extraction of skin samples. * Conventional PCR for low-risk HPV genotypes (6,11) and RT-PCR for high-risk HPV genotypes. * Intralesional injection of the quadrivalent HPV vaccine (Gardasil) at a dose of 0.5ml, into the largest wart at 4-week intervals until complete clearance is achieved or for a maximum of three sessions. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with clinically diagnosed multiple anogenital warts who had not received treatment in the last 2 months before the study
Key exclusion criteria (1 listed)
- Patient refusal, pregnancy, lactation, age less than 10 years, and immunosuppressive conditions
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 |
|---|---|---|
| the Quadrivalent Vaccine (Gardasil)• Intralesional injection of the quadrivalent HPV vaccine (Gardasil) at a dose of 0.5ml, into the largest wart at 4-week intervals until complete clearance is achieved or for a maximum of three sessions. | Biological | treatment group |
Primary outcome
improvement of lesion
Time frame: 6 month
The response will be considered complete if there is disappearance of the warts, partial if the warts regressed in size by 50-99% and no response if there is 0-49% decrease in wart size.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Quadrivalent Vaccine (Gardasil) in people with Human Papilloma Virus and Anogenital Wart, 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 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of lesion (time frame: 6 month). 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 9 Mar 2023.