Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts

Zagazig University

Status and phase: Enrolling; Phase 2

Conditions: Human Papilloma Virus; Warts

Treatments: Biological: Candida antigen vaccine; Biological: Bivalent HPV vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05291845

C.ag-vs-B.HPV.V

Details and patient eligibility

About

To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy

Full 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

Enrollment: 162 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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162 participants in 3 patient groups

Candida antigen group

Experimental group

Description:

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.

Treatment:

Biological: Candida antigen vaccine

Bivalent HPV vaccine

Experimental group

Description:

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.

Treatment:

Biological: Bivalent HPV vaccine

both agents group

Experimental group

Description:

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.

Treatment:

Biological: Bivalent HPV vaccine

Biological: Candida antigen vaccine