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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that HPV Vaccine for Warts is an effective treatment?

The available research shows that the HPV Vaccine for Warts, also known as Gardasil 9, is highly effective in preventing infections caused by various types of the human papillomavirus (HPV). The vaccine covers nine different HPV types, which increases its protection level from about 70% to 90% compared to earlier versions. Clinical trials have demonstrated that the vaccine is safe and effective, especially in young women, and it produces a strong immune response in younger boys and girls. This makes it a powerful tool in preventing diseases related to HPV, such as cervical cancer. ^{1 2 3 4 5}

What safety data is available for the 9-valent HPV vaccine?

The safety of the 9-valent HPV vaccine, also known as Gardasil 9, has been evaluated in several studies. A multiyear post-licensure study assessed its safety following routine administration. Another study focused on its safety and immunogenicity in females aged 12-26 who previously received the quadrivalent HPV vaccine. Additionally, a study evaluated its safety when given with other vaccines to adolescents aged 11-15. A combined analysis of 7 Phase III clinical trials also assessed the overall safety profile of the vaccine in males and females aged 9 to 26. These studies consistently report that the 9-valent HPV vaccine is safe for use. ^{1 3 6 7 8}

Is the HPV Vaccine for Warts a promising drug?

Yes, the HPV Vaccine for Warts, known as Gardasil 9, is a promising drug. It is designed to protect against nine types of HPV, which are linked to cervical cancer and other diseases. Studies show it is safe and effective, offering up to 90% protection against these HPV types. It works well in both boys and girls, making it a valuable tool for preventing HPV-related health issues. ^{1 2 3 9 10}

Research Team

Lowell Nicholson, MD

Principal Investigator

University of Utah Health Care System

Eligibility Criteria

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 am 18 years old or older.

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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) 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]

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]

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 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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. [2019]

3. United States 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. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Inpatient Postpartum Vaccination: Clinical Guideline Implementation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Safety of the 9-Valent Human Papillomavirus Vaccine. [2023]

6. Netherlands 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. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. [2019]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Design of a large outcome trial for a multivalent human papillomavirus L1 virus-like particle vaccine. [2015]