Using Candida antigen and a bivalent HPV vaccine to clear multiple common warts

Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy

This study will test whether injections of Candida antigen, a bivalent HPV vaccine, or both can clear multiple common warts in people with persistent or widespread warts.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 9 Years and up
• Sex: All
• Sponsor: Zagazig University (Government)
• Locations: 1 site (Zagazig, Al Sharqia)
• Trial ID: NCT05291845 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study will enroll 162 participants with multiple common warts and randomize them into three groups receiving intralesional Candida antigen, intralesional bivalent HPV vaccine, or a combination of both. Injections are given into the largest wart every two weeks until complete clearance or for a maximum of five sessions. The protocol is based on the idea that Candida antigen stimulates cell-mediated immunity while the HPV vaccine stimulates humoral immunity, and combining them may improve clearance rates. Primary outcomes include wart clearance and safety/tolerability.

Who should consider this trial

Good fit: People with multiple common warts, including recalcitrant or widespread lesions, who can attend biweekly clinic visits and are not pregnant or allergic to the study agents would be suitable candidates.

Not a fit: Pregnant individuals and anyone with a known hypersensitivity to Candida antigen or the bivalent HPV vaccine are excluded and would not be expected to benefit, and patients with single isolated lesions or non-HPV skin conditions may derive little advantage.

Why it matters

Potential benefit: If successful, this approach could provide a simple in-clinic injection option that clears multiple warts and lowers recurrence without more invasive procedures.

How similar studies have performed: Prior small trials and case series have reported clearance of warts with intralesional Candida antigen, while intralesional use of HPV vaccines is less well established but has some preliminary supportive reports.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine

Where this trial is running

Zagazig, Al Sharqia

• Reham Essam — Zagazig, Al Sharqia, Egypt (Recruiting)

Study contacts

• Principal investigator: Reham Essam, MD — Zagazig University
• Study coordinator: Reham Essam, MD

Conditions Warts; Human Papilloma Virus