HPV Vaccine for Warts

Recruiting at 1 trial location

Overseen By Jamie Rhoads, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Western Institute for Veterans Research

Disqualifiers: Untreated warts, Anogenital warts, Oral warts, Immunosuppression, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 20 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the HPV vaccine can treat stubborn skin warts that resist other treatments. Participants will receive either the HPV vaccine or a placebo (a harmless shot with no active ingredients) to determine the vaccine's effectiveness against these warts. The trial seeks individuals who have tried treatments like freezing or salicylic acid but still have persistent warts. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received treatment for cutaneous warts in the past 4 weeks, and you cannot receive any other investigational treatment during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Human Papillomavirus 9-valent Vaccine, known as Gardasil 9, is generally safe. The FDA approved this vaccine in 2014 after it passed extensive safety tests. Studies indicate that most people tolerate the vaccine well. Common side effects include temporary pain, mild swelling, and redness at the injection site. Serious side effects are rare, though a few reports require further investigation. Overall, the vaccine is considered safe for protecting against certain types of HPV. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for warts?

Researchers are excited about the HPV 9-valent vaccine for treating warts because it targets the root cause of the condition—the human papillomavirus (HPV)—by boosting the body's immune response. Unlike conventional treatments like topical creams or cryotherapy that only address the symptoms, this vaccine aims to prevent the recurrence of warts by addressing the underlying viral infection. The 9-valent formulation is particularly promising as it covers multiple HPV strains, potentially offering broader protection and long-term benefits. This innovative approach could significantly reduce the need for repeated treatments, providing a more effective and lasting solution for patients.

What evidence suggests that the HPV vaccine might be an effective treatment for warts?

Research shows that the 9-valent HPV vaccine provides strong and lasting protection against various types of human papillomavirus (HPV), including those that can cause cervical cancer and genital warts. Studies have found this vaccine to be safe and effective in preventing these infections and related diseases. In this trial, some participants will receive the 9-valent HPV vaccine to assess its potential in treating warts. Persistent HPV infections are linked to warts, so the vaccine might help clear stubborn warts by enhancing the body's ability to fight the virus. ^{6 7 8 9 10}

Who Is on the Research Team?

Lowell Nicholson, MD

Principal Investigator

University of Utah Health Care System

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stubborn skin warts that haven't gone away after treatments like freezing, acids, or injections. Participants must understand the study and agree to it in writing. People can't join if they have genital or oral warts, are very sick right now, have a weak immune system, are allergic to HPV vaccines, might get pregnant, or had wart treatment in the last month.

Inclusion Criteria

I have been diagnosed with skin warts.

Must be able to understand and provide written informed consent

I have tried treatments for skin warts before.

Exclusion Criteria

I have warts in the genital or anal area.

I am currently experiencing a severe illness.

I have warts in my mouth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections with the 9-valent HPV vaccine or placebo at weeks 0, 4, and 20

20 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Human Papillomavirus 9-valent Vaccine, Recombinant

Trial Overview The study tests if the HPV vaccine can treat tough-to-remove skin warts compared to a placebo (a harmless saline solution). It's a double-blind trial where neither participants nor researchers know who gets the real vaccine or placebo until after results are collected.

How Is the Trial Designed?

Group I: HPV Vaccine Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Human Papillomavirus 9-valent Vaccine, Recombinant is already approved in United States, European Union for the following indications:

Approved in United States as Gardasil 9 for:

• Cervical cancer
• Vulvar and vaginal cancers
• Anal cancer
• Certain head and neck cancers
• Genital warts
• Precancerous cervical, vaginal, vulvar, and anal lesions

Approved in European Union as Gardasil 9 for:

• Cervical cancer
• Vulvar and vaginal cancers
• Anal cancer
• Certain head and neck cancers
• Genital warts
• Precancerous cervical, vaginal, vulvar, and anal lesions

Who Is Running the Clinical Trial?

Western Institute for Veterans Research

Lead Sponsor

Trials

2

Recruited

180+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

The 9-valent HPV vaccine (9vHPV) is highly immunogenic in females aged 12-26 who previously received the quadrivalent HPV vaccine (qHPV), with over 98% showing seropositivity for additional HPV types 31/33/45/52/58 after the third dose.

While injection-site adverse events were more common in the 9vHPV group (91.1%) compared to placebo (43.9%), systemic adverse events were similar between both groups, indicating that the 9vHPV vaccine is generally well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Garland, SM., Cheung, TH., McNeill, S., et al.[2016]

The nine-valent HPV vaccine, Gardasil9, significantly increases the efficacy against cervical cancer from 70% to 90% compared to the quadrivalent vaccine, covering a broader range of HPV types.

Gardasil9 also provides high efficacy (97%) against lesions associated with HPV types 31, 33, 45, 52, and 58, while maintaining similar effectiveness against HPV types 6, 11, 16, and 18 as the quadrivalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. Fait, T., Dvořák, V., Pilka, R.[2018]

A total of 7244 adverse event reports were received after the 9-valent HPV vaccine (9vHPV) was administered, with 97.4% of these reports classified as nonserious, indicating a favorable safety profile.

No new safety concerns were identified, and the adverse events reported were consistent with those observed in prelicensure trials, confirming that the 9vHPV vaccine is safe for use in the approved age group of 9 to 26 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the 9-Valent Human Papillomavirus Vaccine. Shimabukuro, TT., Su, JR., Marquez, PL., et al.[2023]

The 9-valent HPV vaccine (9vHPV) is safe and highly effective, showing over 99.8% seroconversion rates for all vaccine types in both groups of a study involving 1054 participants aged 11-15 years.

Administering the 9vHPV vaccine alongside the REPEVAX vaccine did not interfere with the immune response to either vaccine, indicating that this approach can safely reduce the number of vaccination visits needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age. Kosalaraksa, P., Mehlsen, J., Vesikari, T., et al.[2015]

The 9-valent HPV vaccine (Gardasil 9®) significantly increases protection against cervical cancer by covering 9 oncogenic HPV types, raising potential protection from about 70% to 90%, based on clinical trials involving young women.

Clinical trials demonstrated that the 9vHPV vaccine has a comparable safety profile and immunogenicity to the original 4-valent vaccine, with a 2-dose regimen showing similar effectiveness in younger boys and girls compared to the standard 3-dose regimen for older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. Zhang, Z., Zhang, J., Xia, N., et al.[2019]

The 9-valent HPV vaccine (9vHPV) was shown to produce a non-inferior antibody response against HPV types 6, 11, 16, and 18 compared to the existing quadrivalent HPV vaccine (qHPV), indicating it is at least as effective in generating an immune response for these types.

The 9vHPV vaccine demonstrated superior efficacy against additional HPV types (31, 33, 45, 52, and 58), suggesting it provides broader protection against HPV-related diseases than the qHPV vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a large outcome trial for a multivalent human papillomavirus L1 virus-like particle vaccine. Luxembourg, A., Bautista, O., Moeller, E., et al.[2015]

The 9-valent HPV vaccine demonstrated a high efficacy of 92.3% in preventing high-grade cervical, vulvar, and vaginal dysplasia related to HPV types 31, 33, 45, 52, and 58 in a study involving 5,312 participants aged 9-26 years.

The vaccine was well tolerated, with over 99% of recipients developing antibodies for all 9 HPV types, and most adverse events were mild to moderate, supporting its use in vaccination programs in Latin America.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Ruiz-Sternberg, ÁM., Moreira, ED., Restrepo, JA., et al.[2021]

In a study of 569 postpartum inpatients, 23.1% of vaccine-eligible patients received the nine-valent HPV (9vHPV) vaccine during their hospital stay, indicating that integrating vaccination into postpartum care can increase uptake.

The study found that certain demographics, particularly Hispanic, Spanish-speaking, and publicly insured patients, were more likely to receive the vaccine, suggesting that targeted approaches in postpartum care could help reduce vaccination disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Inpatient Postpartum Vaccination: Clinical Guideline Implementation. Murphy, EC., Alimena, S., Pelletier, A., et al.[2023]

The 9-valent HPV vaccine (9vHPV) was well tolerated in over 15,000 participants aged 9 to 26, with a safety profile similar to the quadrivalent HPV vaccine, showing mostly mild-to-moderate adverse events like injection-site pain and headaches.

Serious adverse events were very rare (0.1%), and the vaccine did not show any significant safety concerns related to pregnancy outcomes, supporting its widespread use for HPV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Moreira, ED., Block, SL., Ferris, D., et al.[2019]

A study involving 215,965 individuals who received the nine-valent HPV vaccine (HPV9) found no new safety concerns, confirming its established safety profile from previous research.

While some elevated event categories were noted, such as skin disorders and ill-defined conditions, most were either previously known or had other causes, and no deaths were linked to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. Hansen, J., Yee, A., Lewis, N., et al.[2023]

Citations

1. cdc.gov cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html

HPV Vaccine Safety and Effectiveness Data More than 15 years of monitoring and research have accumulated reassuring evidence that HPV vaccination provides safe, effective, and long-lasting protection.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7565290/

Human Papillomavirus Vaccines: An Updated Review - PMC Quadrivalent Gardasil shows excellent efficacy against cervical HPV infection, cervical cancer precursor lesions, and genital warts caused by the HPV types ...

3. merckvaccines.com merckvaccines.com/gardasil9/efficacy/

Efficacy of GARDASIL®9 (Human Papillomavirus 9-valent ... Efficacy and effectiveness of GARDASIL are relevant to GARDASIL 9 since the vaccines are manufactured similarly and contain 4 of the same HPV L1 VLPs. In men ...

4. publications.aap.org publications.aap.org/pediatrics/article/152/4/e2022060993/193886/Ten-Year-Follow-up-of-9-Valent-Human

Ten-Year Follow-up of 9-Valent Human Papillomavirus ... Immunogenicity, effectiveness, and safety were demonstrated through 10 years postvaccination. Rates of persistent infection and disease related ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4865336/

Update on the new 9-valent vaccine for human ... The 9-valent HPV vaccine, which protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, is safe and effective and will further reduce the incidence ...

6. cdc.gov cdc.gov/vaccine-safety/vaccines/hpv.html

Human Papillomavirus (HPV) Vaccine Safety Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant; 9vHPV) was approved by FDA for use in 2014. The safety of Gardasil 9 was studied in clinical ...

7. gardasil9.com gardasil9.com/patient-pd/what-is-gardasil-9/safety-and-side-effects/

GARDASIL 9 safety and side effects GARDASIL 9 helps protect individuals ages 9 to 45 against the following diseases caused by 9 types of HPV: cervical, vaginal, and vulvar cancers in females, ...

8. merck.com merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf

gardasil_9_pi.pdf GARDASIL 9, Human Papillomavirus 9-valent Vaccine, Recombinant, is a non-infectious recombinant. 9-valent vaccine prepared from the purified virus-like ...

9. fda.gov fda.gov/vaccines-blood-biologics/vaccines/gardasil-9

Gardasil 9 Product approval information for Human Papillomavirus 9-valent Vaccine, Recombinant also known as Gardasil 9.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12269663/

Adverse events following 9-valent human papillomavirus ... This VAERS-based analysis supports the established safety of GARDASIL 9 while highlighting rare signals that warrant further investigation.