Recruiting
Phase 2
Phase 3

HPV Vaccination

Sponsor:

Western Institute for Veterans Research

Code:

NCT05625633

Conditions

Warts

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Human Papillomavirus 9-valent Vaccine, Recombinant

Normal Saline

Study Details

Brief summary:

This double-blinded clinical trial randomly assigns participants with refractory cutaneous warts to receive either treatment with the human papillomavirus (HPV) vaccine or a placebo to assess the efficacy of HPV vaccination for the treatment of refractory cutaneous warts.

Conditions

Warts

Study ID

NCT05625633

Start date

Mar 25, 2024

Status verified date

Apr, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Must be able to understand and provide written informed consent
2. Age 18 or older
3. Clinical diagnosis of cutaneous warts
4. Must have received prior treatment for cutaneous warts (such as curettage, cryotherapy, salicylic acid, intralesional Candida antigen injection, etc.)

Exclusion Criteria:

1. Untreated cutaneous warts
2. Anogenital warts
3. Oral warts
4. Treatment for cutaneous warts in the past 4 weeks
5. Active acute illness
6. Immunosuppression
7. Known hypersensitivity to HPV vaccination
8. Subjects may not receive any other investigational treatment
9. Pregnancy or planned pregnancy during the study period

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HPV Vaccine

0.5-mL suspension of 9-valent Gardasil vaccine administered as intramuscular injection at weeks 0, 4, and 20

placebo comparator: Placebo

0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20

Interventions

Human Papillomavirus 9-valent Vaccine, Recombinant

0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks 0, 4, and 20

Normal Saline

0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20

Primary outcome measure

  • Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 24 weeks [ Time Frame: Response to treatment assessments will occur 24 weeks after first dose of vaccine/placebo (primary endpoint) ]
  • Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 4 weeks [ Time Frame: Response to treatment assessments will occur 4 weeks after first dose of vaccine/placebo ]
  • Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 8 weeks [ Time Frame: Response to treatment assessments will occur at 8 weeks after first dose of vaccine/placebo ]

Central Contacts and Locations

Central contacts

Lowell Nicholson, MD

801-581-2121lowell.nicholson@hsc.utah.edu

Jamie Rhoads, MD

801-581-2121jamie.rhoads@hsc.utah.edu

Locations

University of Utah Midvalley Health Center

Recruiting

Salt Lake City, Utah, United States, 84107

Contacts

Lowell Nicholson, MD

801-581-2121lowell.nicholson@hsc.utah.edu

Principal Investigator:

Lowell Nicholson, MD

VA Salt Lake City Health Care System

Recruiting

Salt Lake City, Utah, United States, 84148

Contacts

Jamie Rhoads, MD

801-582-1565jamie.rhoads@hsc.utah.edu

Principal Investigator:

Jamie Rhoads, MD

More Information

Sponsor

Western Institute for Veterans Research

Last update posted

Apr 5, 2024

Last verified

Apr, 2024

Keywords

  • Refractory cutaneous warts
  • Human Papillomavirus (HPV) Vaccination
  • HPV vaccine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Western Institute for Veterans Research on 2024-04-05.