HPV Vaccine for Warts

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Lowell Nicholson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Western Institute for Veterans Research

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

Prior Safety Data

Approved in 2 Jurisdictions

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}

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.

Trial 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 (Cancer Vaccine)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Utah Midvalley Health Center Salt Lake City, UT

VA Salt Lake City Health Care System Salt Lake City, UT

Who Is Running the Clinical Trial?

Western Institute for Veterans Research Lead Sponsor

University of Utah Collaborator

Merck Sharp & Dohme LLC Industry Sponsor

References

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

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023] The nine-valent human papillomavirus vaccine (HPV9, Gardasil®9) was licensed in the USA in December 2014. This study was a multiyear post-licensure study to assess HPV9 safety following routine administration.

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] Human papillomavirus is considered the causative factor for cervical cancer, which accounts for approximately 5% of the global cancer burden and more than 600,000 new cases annually that are attributable to HPV infection worldwide. The first-generation prophylactic HPV vaccines, Gardasil® and Cervarix®, were licensed approximately a decade ago. Both vaccines contain the most prevalent high-risk types, HPV16 and 18, which are associated with 70% of cervical cancer. To further increase the type coverage, 5 additional oncogenic HPV types (31, 33, 45, 52 and 58) were added to the existing Gardasil-4 to develop a 9-valent HPV vaccine (9vHPV), Gardasil 9®, increasing the potential level of protection from ∼70% to ∼90%. The efficacy of the vaccine lies primarily in its ability to elicit type-specific and neutralizing antibodies to fend off the viral infection. Therefore, type-specific and neutralizing murine monoclonal antibodies (mAbs) were used to quantitate the antigenicity of the individual vaccine antigens and to measure the antibody levels in the serum samples from vaccinees in a type- and epitope-specific manner in a competitive immunoassay. Assays for 9vHPV are extended from the proven platform used for 4vHPV by developing and adding new mAbs against the additional types. In Phase III clinical trials, comparable safety profile and immunogenicity against the original 4 types were demonstrated for the 9vHPV vaccine, and these were comparable to the 4vHPV vaccine. The efficacy of the 9vHPV vaccine was established in trials with young women. Immunobridging for younger boys and girls was performed, and the results showed higher immunogenicity in the younger age group. In a subsequent clinical trial, the 2-dose regimen of the 9vHPV vaccine used among girls and boys aged 9-14 y showed non-inferior immunogenicity to the regular 3-dose regimen for young women (aged 16-26 years). Overall, the clinical data and cost-effectiveness analysis for the 9vHPV vaccine support its widespread use to maximize the impact of this important, life-saving vaccine.

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] A 9-valent human papillomavirus (9vHPV) vaccine has recently been reported to be safe and highly efficacious against infection and disease related to HPV6/11/16/18/31/33/45/52/58. We evaluated the immunogenicity and safety of the 9vHPV vaccine administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine).

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

Human Papillomavirus Inpatient Postpartum Vaccination: Clinical Guideline Implementation. [2023] The nine-valent human papillomavirus (9vHPV) vaccine is highly effective at preventing cervical cancer, yet U.S. vaccination rates remain low. The objective of this study was to evaluate integration of 9vHPV inpatient vaccination into routine postpartum care.

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

Safety of the 9-Valent Human Papillomavirus Vaccine. [2023] The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS).

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] To assess the safety and immunogenicity of the investigational 9-valent (6/11/16/18/31/33/45/52/58) HPV (9vHPV) vaccine in prior recipients of a 3-dose regimen of quadrivalent (6/11/16/18) HPV (qHPV) vaccine.

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] The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age.

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

[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018] To evaluate current knowledge about new generation of HPV vaccine - nine-valent vaccine Gardasil9.

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] A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine.

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] The 9-valent human papillomavirus (HPV) (9vHPV) vaccine targets the four HPV types (6/11/16/18) covered by the licensed quadrivalent HPV (qHPV) vaccine and five additional types (31/33/45/52/58). A large outcome trial of 9vHPV vaccine was conducted.