WartsPhase 2NCT05291845
Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts
A Phase 2 study testing Candida antigen vaccine and Bivalent HPV vaccine in people with Warts and Human Papilloma Virus, run by Zagazig University at 1 site in Egypt.
Trial summary
To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Warts, Human Papilloma Virus
- What is being tested?
- Candida antigen vaccine and Bivalent HPV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2022to 6 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with multiple, recalcitrant, or non-recalcitrant common warts of different sites, sizes, duration, and with or without distant lesions will be enrolled in the study
Who cannot join
- Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Reham Essam
Zagazig, Al Sharqia, 2543
Reham Essam, 01097709477, rereessam22@gmail.com
About this study
Official title: Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy
To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy
Read the detailed description
- Group A: 54 patients will be treated with Candida antigen. All patients will be directly injected with Candida antigen into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
- Group B: 54 patients will be treated with bivalent HPV vaccine solution intralesional into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
- Group C: 54 patients will be treated with both agents intralesionally into the largest wart using an insulin syringe at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. it is thought that candida antigen act through a cell-mediated immune response and bivalent HPV vaccine act mainly through humoral immunity, so we want to study their effect as single or mixed agents
- Conditions
- Warts, Human Papilloma Virus
- Being tested
- Candida antigen vaccine, Bivalent HPV vaccine
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candida antigen vaccineBiological
we will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group
Bivalent HPV vaccineBiological
we will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group
| Study group | Role | What they receive |
|---|---|---|
| Candida antigen group | Experimental | 54 patients will be treated with Candida antigen. All patients will be directly injected with Candida antigen into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. Receives: Biological: Candida antigen vaccine |
| Bivalent HPV vaccine | Experimental | 54 patients will be treated with the Bivalent HPV vaccine. All patients will be directly injected with the vaccine into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. Receives: Biological: Bivalent HPV vaccine |
| both agents group | Experimental | 54 patients will be treated with Both agents at the same session. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. Receives: Biological: Candida antigen vaccine; Biological: Bivalent HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response
if there is disappearance of warts and return of the normal skin markings
Measured: upto 3 months
partial response
if warts regressed in size by 50-99% (the size will be measured as the summation of size of all lesions in cm)
Measured: upto 3 months
no response
if there is < 50% decrease in wart size. (the size will be measured as the summation of size of all lesions in cm)
Measured: upto 3 months
Secondary outcomes (1)
recurrence rate after recovery
appearance of new lesions or recurrence of previous one
Measured: follow up for 6 months after recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start3 Apr 2022
- Primary completion3 Oct 2025 (estimated)
- Study completion6 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Essam, Zagazig University
- Investigators
- Reham Essam, MD, Principal investigator, Zagazig UniversityAhmad Nofal, MD, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291845
- Sponsor's protocol ID
- C.ag-vs-B.HPV.V
- Status last verified
- Apr 2025
- First submitted
- 14 Mar 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nofal A, Marei A, Ibrahim AM, Nofal E, Nabil M. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020 Jan;82(1):94-100. doi: 10.1016/j.jaad.2019.07.070. Epub 2019 Jul 29.
PubMed 31369771Nassar A, Alakad R, Essam R, Bakr NM, Nofal A. Comparative efficacy of intralesional Candida antigen, intralesional bivalent human papilloma virus vaccine, and cryotherapy in the treatment of common warts. J Am Acad Dermatol. 2022 Aug;87(2):419-421. doi: 10.1016/j.jaad.2021.08.040. Epub 2021 Aug 28. No abstract available.
PubMed 34464624
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy
- ClinicalTrials.gov ID
- NCT05291845
- Acronym / sponsor ID
- C.ag-vs-B.HPV.V
- Conditions
- Warts, Human Papilloma Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 3 Apr 2022 (actual)
- Primary completion
- 3 Oct 2025 (estimated)
- Study completion
- 6 Dec 2025 (estimated)
- First posted
- 23 Mar 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.
To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy
Detailed description
- Group A: 54 patients will be treated with Candida antigen. All patients will be directly injected with Candida antigen into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
- Group B: 54 patients will be treated with bivalent HPV vaccine solution intralesional into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
- Group C: 54 patients will be treated with both agents intralesionally into the largest wart using an insulin syringe at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. it is thought that candida antigen act through a cell-mediated immune response and bivalent HPV vaccine act mainly through humoral immunity, so we want to study their effect as single or mixed agents
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Candida antigen group | Experimental | Biological: Candida antigen vaccine54 patients will be treated with Candida antigen. All patients will be directly injected with Candida antigen into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. |
| Bivalent HPV vaccine | Experimental | Biological: Bivalent HPV vaccine54 patients will be treated with the Bivalent HPV vaccine. All patients will be directly injected with the vaccine into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. |
| both agents group | Experimental | Biological: Candida antigen vaccine, Biological: Bivalent HPV vaccine54 patients will be treated with Both agents at the same session. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with multiple, recalcitrant, or non-recalcitrant common warts of different sites, sizes, duration, and with or without distant lesions will be enrolled in the study
Key exclusion criteria (1 listed)
- Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine
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 |
|---|---|---|
| Candida antigen vaccinewe will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group | Biological | Candida antigen group, both agents group |
| Bivalent HPV vaccinewe will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group | Biological | Bivalent HPV vaccine, both agents group |
Primary outcome
complete response
Time frame: upto 3 months
if there is disappearance of warts and return of the normal skin markings
partial response
Time frame: upto 3 months
if warts regressed in size by 50-99% (the size will be measured as the summation of size of all lesions in cm)
no response
Time frame: upto 3 months
if there is < 50% decrease in wart size. (the size will be measured as the summation of size of all lesions in cm)
1 secondary outcome
recurrence rate after recovery
Time frame: follow up for 6 months after recovery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Results publication: PubMed 31369771Nofal A, Marei A, Ibrahim AM, Nofal E, Nabil M. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020 Jan;82(1):94-100. doi: 10.1016/j.jaad.2019.07.070. Epub 2019 Jul 29.
- Results publication: PubMed 34464624Nassar A, Alakad R, Essam R, Bakr NM, Nofal A. Comparative efficacy of intralesional Candida antigen, intralesional bivalent human papilloma virus vaccine, and cryotherapy in the treatment of common warts. J Am Acad Dermatol. 2022 Aug;87(2):419-421. doi: 10.1016/j.jaad.2021.08.040. Epub 2021 Aug 28. No abstract available.
- Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common wartsLink provided by the sponsor.
- Comparative efficacy of intralesional Candida antigen, intralesional bivalent human papilloma virus vaccine, and cryotherapy in the treatment of common wartsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Reham Essam, MD principal investigator
Zagazig University
Ahmad Nofal, MD study director
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Candida antigen vaccine and Bivalent HPV vaccine in people with Warts and Human Papilloma Virus, 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reham Essam, MD (+201097709477, rereessam22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (time frame: upto 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291845, which also lists 2 linked publications.
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 12 Jun 2025.