9vHPV Vaccine for HPV-Related Oral Infections in Men

Recruiting at 102 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

6033 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.

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.

What data supports the effectiveness of the 9vHPV vaccine for preventing HPV-related oral infections in men?

The 9vHPV vaccine is designed to protect against nine types of HPV, which are linked to various cancers and diseases, including those affecting the mouth. Studies have shown that similar vaccines, like the quadrivalent HPV vaccine, are effective in preventing HPV-related diseases in men, suggesting that the 9vHPV vaccine could also be effective in preventing oral HPV infections. ^{1 2 3 4 5}

Is the 9vHPV vaccine safe for men?

The 9vHPV vaccine is generally well tolerated in men, with most side effects being mild, such as reactions at the injection site. Serious side effects are rare, and the safety profile is similar to the previously used quadrivalent HPV vaccine. ^{3 6 7 8 9}

How is the 9vHPV vaccine different from other treatments for HPV-related oral infections in men?

The 9vHPV vaccine is unique because it targets nine different types of HPV, including five additional types not covered by the earlier quadrivalent vaccine, potentially offering broader protection against HPV-related oral infections. ^{3 10 11 12 13}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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) 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]

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]

References

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

Seroprevalence and Associated Factors of 9-Valent Human Papillomavirus (HPV) Types among Men in the Multinational HIM Study. [2020]

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

Overview of the benefits and potential issues of the nonavalent HPV vaccine. [2017]

3. Netherlands 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. [2017]

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

Human papillomavirus-related disease in men: not just a women's issue. [2022]

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

Quadrivalent Human Papillomavirus (HPV) Vaccine Induces HPV-Specific Antibodies in the Oral Cavity: Results From the Mid-Adult Male Vaccine Trial. [2018]

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

Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. [2022]

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

Safety of 4-valent human papillomavirus vaccine in males: a large observational post-marketing study. [2022]

8. United States 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. [2019]

9. 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]

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

Oral Human Papillomavirus Infection in Men Who Have Sex with Men: A Systematic Review and Meta-Analysis. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Anal and oral human papillomavirus infection in men who have sex with men: implications for risk-targeted vaccination. [2021]

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

High Baseline Anal Human Papillomavirus and Abnormal Anal Cytology in a Phase 3 Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus-Infected Individuals Older Than 26 Years: ACTG 5298. [2019]

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

Prevalence of Anal Human Papillomavirus Vaccine Types in the Bangkok Men Who Have Sex With Men Cohort Study. [2015]