9vHPV Vaccine for HPV-Related Oral Infections in Men

Not currently recruiting at 120 trial locations

Age: 18 - 65

Sex: Male

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme Corp.

Must not be taking: Immunosuppressants, Corticosteroids, Chemotherapy, others

Disqualifiers: Immunocompromised, Autoimmune conditions, Drug abuse, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well the vaccine 9vHPV can prevent oral infections caused by certain types of human papillomavirus (HPV) in men. It aims to determine if three doses of this vaccine can reduce the risk of persistent HPV infections. Men who are generally healthy, have had at least one sexual partner, and are interested in advancing medical research on HPV-related conditions might be suitable candidates. Participants receive either the vaccine or a placebo (saline for injection), and those in the placebo group can later receive the vaccine in the study's extension phase. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking preventive treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapies or certain other treatments, you may not be eligible to participate.

Is there any evidence suggesting that the 9vHPV vaccine is likely to be safe for humans?

Research has shown that the 9vHPV vaccine is safe and effective in preventing infections and cancers caused by HPV. Studies have found that this vaccine, administered in three doses, can reduce the risk of persistent oral HPV infections. Gardasil 9, the vaccine, is approved for individuals aged 9 to 45 to protect against diseases caused by nine types of HPV.

While vaccines can cause side effects, most are mild, such as pain at the injection site, headache, or fever. Serious side effects are rare. The approval and widespread use of the vaccine for other HPV-related conditions indicate it is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for HPV-related oral infections focus on managing symptoms rather than preventing the infection. Unlike these standard approaches, the 9vHPV vaccine targets the root cause by preventing infection with nine types of human papillomavirus, potentially decreasing the risk of developing oral infections altogether. Researchers are excited about this vaccine because it offers a proactive approach, aiming to stop HPV-related conditions before they even start. Additionally, the vaccine's delivery through a simple intramuscular injection makes it easy to administer and integrate into existing vaccination programs.

What evidence suggests that the 9vHPV vaccine might be an effective treatment for HPV-related oral infections?

In this trial, participants will receive either the 9vHPV vaccine or a placebo. Studies have shown that the 9vHPV vaccine, administered in three doses, effectively reduces the risk of persistent oral HPV infection. This vaccine targets nine types of HPV, including those most commonly associated with infections. Research indicates it is both effective and safe, making it a strong option for reducing HPV-related oral infections in men aged 20 to 45. Receiving all three doses is crucial for optimal effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Men aged 20-45 who are generally healthy, have had at least one sexual partner, and can complete an electronic vaccination report card. They must not have a history of HPV-related cancers or lesions, severe allergies to vaccine components, immune system problems, or be taking certain medications that affect the immune response.

Inclusion Criteria

I am healthy and in good physical condition as confirmed by a doctor.

I can read, understand, and complete the electronic vaccination report card (eVRC).

I can join the extended study if I was in the placebo or vaccine group but didn't finish all shots.

Exclusion Criteria

You have allergies to any ingredients in the vaccine, like aluminum, yeast, or BENZONASE®.

I have received an HPV vaccine or participated in an HPV vaccine trial.

I have had or currently have HPV-related lesions on my genitals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 3-dose regimen of the 9vHPV vaccine or placebo at Day 1, Month 2, and Month 6

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of persistent oral infection and adverse events

Up to Month 90

Extension Study

Participants who received placebo or less than 3 doses of 9vHPV vaccine in the Base Study can complete the 3-dose regimen

What Are the Treatments Tested in This Trial?

Interventions

• 9vHPV Vaccine
• Placebo (Saline for Injection)

Trial Overview The trial is testing the effectiveness of the 9-valent human papillomavirus (9vHPV) vaccine in preventing persistent oral HPV infections compared to a saline placebo. Participants will receive three doses and those initially given a placebo may later receive the actual vaccine.

How Is the Trial Designed?

Group I: 9vHPV vaccine Experimental Treatment 1 Intervention

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6

Group II: Placebo Placebo Group 1 Intervention

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

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

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

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

Merck Sharp & Dohme LLC

Lead 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 nine-valent HPV (9vHPV) vaccine demonstrated comparable immune responses to the quadrivalent HPV (qHPV) vaccine for HPV types 6/11/16/18, while also effectively eliciting immune responses for five additional oncogenic HPV types (31/33/45/52/58) in a study of 500 men aged 16-26.

Both the 9vHPV and qHPV vaccines exhibited similar safety profiles, indicating that the 9vHPV vaccine is a safe and effective option for preventing a broader range of HPV-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. Van Damme, P., Meijer, CJLM., Kieninger, D., et al.[2017]

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 nonavalent HPV vaccine (9vHPV) has shown increased efficacy compared to the quadrivalent HPV vaccine (4vHPV), with an estimated 90% prevention rate for cervical cancer and up to 80% for precancerous cervical lesions in women aged 16-26 years.

The 9vHPV vaccine may provide broader protection against various HPV-related diseases in both males and females, but its future adoption will depend on factors like cost-effectiveness and ongoing safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the benefits and potential issues of the nonavalent HPV vaccine. Mariani, L., Preti, M., Cristoforoni, P., et al.[2017]

The 9-valent HPV vaccine (9vHPV) has been shown to be generally well tolerated in both prior recipients of the quadrivalent HPV vaccine and young men, with a low incidence of serious adverse events (AEs).

The most common AEs were mild injection-site reactions, occurring in over 90% of prior qHPV vaccine recipients and 79% of young men, indicating that the vaccine is safe for use in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Moreira, ED., Giuliano, AR., de Hoon, J., et al.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X25007443

Vaccine The 9vHPV vaccine when given in a 3-dose regimen (Day 1, Months 2 and 6) reduces the incidence of persistent (≥6 months) oral HPV infection.

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04199689?cond=Infections&aggFilters=status:act&viewType=Table&rank=4

Study Details | Efficacy Against Oral Persistent Infection ... The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9833124/

Impact of HPV vaccination on HPV-related oral infections - PMC One HPV vaccine dose may be less efficient in preventing oral HPV infection. •. No difference was observed between one dose vaccinated and unvaccinated women.

5. merck.com merck.com/news/merck-to-present-new-data-from-gardasil9-studies-reinforcing-the-importance-of-gender-neutral-hpv-vaccination-in-adults-up-to-age-45-at-the-international-papillomavirus-conference-ipvc-2024/

Merck to Present New Data From GARDASIL®9 Studies ... Data to be presented include results from the BROADEN and PROGRESS studies evaluating the prevalence of oral HPV infection and burden of HPV- ...

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

Human Papillomavirus (HPV) Vaccine Safety HPV vaccine is safe and effective at preventing HPV-related infections and cancers. Vaccines, like any medicine, can have side effects. Many people who get ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40609265/

ULACNet trial 201 The 9vHPV vaccine when given in a 3-dose regimen (Day 1, Months 2 and 6) reduces the incidence of persistent (≥6 months) oral HPV infection with 9vHPV vaccine ...

8. gardasil9.com gardasil9.com/

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine ... 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.

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-12509

Nine-Valent HPV Vaccine for the Prevention of Persistent ... The main purpose of this study is to determine whether the nine-valent HPV vaccine, Gardasil-9, prevents oral HPV infection in men living with HIV. “Nine-valent ...