What side effects are associated with this type of intervention?

Common treatments for HPV that stimulate the immune response, such as Gardasil 9, imiquimod, and photodynamic therapy, have various side effects. Gardasil 9, an HPV vaccine, is generally well-tolerated but can cause injection site reactions, fever, headache, and fatigue. Imiquimod, a topical immune response modifier, may cause local skin reactions like redness, swelling, and erosion, as well as systemic effects like flu-like symptoms. Photodynamic therapy, which involves the application of a photosensitizing agent followed by light exposure, can lead to pain, burning, and erythema at the treatment site. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for HPV that focus on immune response stimulation. Imiquimod, a topical immune response modifier, is approved for the treatment of external genital warts caused by HPV. Sinecatechins, a botanical extract with immune-modulating properties, is another FDA-approved topical treatment for external genital and perianal warts. Additionally, the Gardasil vaccine series, including Gardasil 9, is approved for the prevention of HPV-related diseases by stimulating an immune response against multiple HPV strains.

What other types of research exist?

Promising novel alternatives to Gardasil 9 for HPV treatment include VGX-3100, an investigational DNA-based immunotherapy aimed at treating cervical High-Grade Squamous Intraepithelial Lesion (HSIL) by inducing histologic regression and HPV16/18 clearance. Additionally, adoptive T cell therapy targeting HPV has shown durable complete responses in metastatic cervical cancer patients.

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Cancer Vaccine

HPV Vaccine for Genital Warts

Phase 1 & 2

Recruiting

Led By Ayan Kusari, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed clinical diagnosis of genital condylomata with minimum of 3 genital condylomata, each measuring >3mm

Be older than 18 years old

Must not have

Use of immune suppressive medications or medical conditions significantly altering the immune system

Previous receipt of any human papillomavirus vaccine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be measured at baseline (week 0) and week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if injecting genital warts with the Gardasil 9 vaccine can reduce their size and number. The study involves patients with genital warts who will receive the vaccine directly into their warts. Researchers hope that this will help the body's immune system fight off the virus causing the warts. Gardasil 9 is a vaccine that has been shown to be highly effective in preventing HPV-related diseases, including genital warts.

Who is the study for?

This trial is for adults over 18 with genital warts, specifically at least three warts larger than 3mm. Participants must not be on immune-suppressing drugs or have conditions affecting their immune system, and they can't be pregnant or planning to become pregnant soon. They also shouldn't have had an HPV vaccine before or be allergic to yeast and vaccine components.

What is being tested?

The study is testing the effects of injecting small amounts of Gardasil 9, a nonavalent human papillomavirus vaccine, directly into genital warts to see if it helps treat them.

What are the potential side effects?

While specific side effects are not listed here, typical reactions may include pain at the injection site, swelling, redness, headaches, fever and nausea. Serious allergic reactions could occur in those with sensitivities to yeast or other vaccine ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with genital warts, with at least 3 warts each bigger than 3mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not on immune suppressive medications nor do I have conditions affecting my immune system.

Select...

I have received an HPV vaccine in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be measured at baseline (week 0) and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be measured at baseline (week 0) and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be measured at baseline (week 0) and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Genitalia

Change in mean size of genital condyloma between Week 0 (baseline) and Week 4

Change in wart number between Week 0 (baseline) and Week 12

+1 more

Secondary study objectives

Change in score of Dermatology quality of life index (DLQI)

Change in score of Specific Questionnaire for Condylomata Acuminata (CECA)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intralesional injection of nonavalent human papillomavirus vaccineExperimental Treatment1 Intervention

Single-arm, open-label study. Intervention consists of intralesional injection of nonavalent human papillomavirus vaccine at 0 and 4 weeks.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Human Papillomavirus (HPV) often focus on stimulating the immune system to recognize and combat the virus. Vaccines like Gardasil 9 work by introducing virus-like particles that trigger an immune response without causing disease, thereby preparing the body to fight off actual HPV infections. Other treatments, such as imiquimod, enhance the body's immune response by activating immune cells to release cytokines that target the virus. Podofilox and sinecatechins directly target wart tissue, causing cell death and reducing viral load. These mechanisms are crucial for HPV patients as they help control the spread of the virus, reduce symptoms, and prevent complications such as cancer.