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Study on the 9vHPV Vaccine for Preventing Oral HPV Infections in Men Aged 20-45

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of oral persistent infections caused by certain types of the human papillomavirus (HPV), specifically types 16, 18, 31, 33, 45, 52, and 58. The study involves adult males aged 20 to 45 years. The treatment being tested is the Gardasil 9 vaccine, which is a suspension for injection designed to protect against nine different types of HPV. The vaccine is given in a series of three doses. A placebo, which looks like the vaccine but does not contain the active ingredients, is also used in the study for comparison.

The purpose of the study is to determine if the Gardasil 9 vaccine can reduce the occurrence of persistent oral infections caused by the specified HPV types over a period of six months or longer. Participants in the study will receive either the vaccine or a placebo and will be monitored for any infections and their immune response to the vaccine. The study will also assess the safety of the vaccine by tracking any side effects or adverse events that participants may experience.

Throughout the study, participants will be asked to attend regular check-ups to monitor their health and the effectiveness of the vaccine. The study aims to provide valuable information on the potential benefits of the Gardasil 9 vaccine in preventing HPV-related oral infections in adult males. The study is expected to continue until 2028, allowing researchers to gather comprehensive data on the vaccine's long-term effects and safety.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent. This confirms your understanding and agreement to participate in the trial.

    You will need to provide a primary telephone number and, if available, an alternate means of contact for follow-up purposes.

  2. Step 2

    Initial health assessment

    A health assessment will be conducted to ensure you are in good physical health. This includes a review of your medical history and a physical examination.

  3. Step 3

    First vaccination

    You will receive the first dose of the 9vHPV vaccine or a saline placebo through an injection into the muscle. This is known as intramuscular use.

    The vaccine is designed to prevent oral persistent infection caused by certain types of human papillomavirus (HPV).

  4. Step 4

    Second vaccination

    Approximately two months after the first dose, you will receive the second dose of the 9vHPV vaccine or the saline placebo.

  5. Step 5

    Third vaccination

    Approximately six months after the first dose, you will receive the third and final dose of the 9vHPV vaccine or the saline placebo.

  6. Step 6

    Follow-up visits

    You will have follow-up visits to monitor your health and the effects of the vaccine. These visits will include assessments to check for any side effects or adverse events.

    You will be asked to complete an electronic vaccination report card (eVRC) to record any symptoms or side effects you experience.

  7. Step 7

    Extension study

    If you were in the placebo group or did not complete the vaccination series, you may be eligible to continue in an extension study. This requires providing additional informed consent.

Who can join the trial?

8 criteria

  • The participant must be healthy and in good physical condition based on their medical history and a physical examination.
  • The participant must be male and between 20 to 45 years old at the time of signing the consent form.
  • The participant must have provided written informed consent to take part in the study. This means they have agreed in writing to participate after being informed about the study.
  • The participant must agree to provide the study team with a primary telephone number and, if possible, an alternate way to contact them, such as another phone number or email, for follow-up purposes.
  • The participant must be able to read, understand, and complete the electronic vaccination report card (eVRC), which is a digital form used to track vaccination details.
  • The participant must have had at least one sexual partner in their lifetime.
  • For the Extension Study, participants can continue if they still meet the first and fourth criteria and were either in the placebo group or did not complete the vaccination series in the Base Study.
  • For the Extension Study, the participant must provide documented informed consent again.

Who cannot join the trial?

8 criteria

  • Participants cannot have a history of **allergic reactions** to any component of the vaccine. An allergic reaction is when your body has a bad response to something, like a rash or trouble breathing.
  • Participants should not have any **immune system disorders**. This means your body's defense system, which fights off illnesses, is not working properly.
  • Participants cannot be currently participating in another clinical trial. This means you should not be involved in any other study testing new treatments or medicines.
  • Participants should not have a history of **severe illness** that could interfere with the study. Severe illness means a very serious health condition that might affect your ability to participate.
  • Participants must not have received any other **HPV vaccines**. HPV vaccines are shots that protect against the human papillomavirus.
  • Participants should not have any **active infections** at the time of the study. An active infection means you currently have an illness caused by bacteria, viruses, or other germs.
  • Participants cannot have a history of **substance abuse**. Substance abuse means using drugs or alcohol in a way that is harmful to your health.
  • Participants should not have any **mental health conditions** that are not well controlled. Mental health conditions are issues that affect your mood, thinking, and behavior.
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Investigated drugs

9vHPV Vaccine is a vaccine designed to protect against nine different types of the human papillomavirus (HPV). This vaccine works by helping your body build immunity against these virus types, which are known to cause infections that can lead to certain cancers and other diseases. In this clinical trial, the vaccine is being tested to see if it can prevent persistent oral infections caused by specific HPV types in adult males. The goal is to see if a series of three doses can effectively reduce the chances of getting these infections compared to not receiving the vaccine.

What is already known about the treatment

9vHPV Vaccine – This vaccine is administered as an injection and is designed to prevent persistent oral infections caused by specific types of human papillomavirus (HPV), namely types 16, 18, 31, 33, 45, 52, and 58. Currently, it is being studied in a Phase 3 clinical trial to assess its effectiveness, immune response, and safety in adult males aged 20 to 45. The main therapeutic use of the 9vHPV vaccine is to reduce the incidence of these HPV-related infections. At the molecular level, the vaccine works by stimulating the body's immune system to recognize and fight off the virus, using virus-like particles that mimic the structure of the actual virus without causing disease. It is classified as a multivalent vaccine, meaning it targets multiple strains of the virus.

Investigated diseases

Human Papillomavirus Infection – Human Papillomavirus (HPV) infection is caused by a group of viruses that can infect the skin and mucous membranes. It often progresses without symptoms, but some types can lead to warts or lesions. Persistent infection with certain high-risk types, such as HPV 16 and 18, can lead to changes in the cells of the infected area. Over time, these changes can progress to precancerous lesions and, if untreated, may develop into cancer. The infection can be transmitted through direct contact, often during sexual activity. The body's immune system can sometimes clear the virus naturally, but persistent infections may require medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501974-21-00Protocol codeV503-049Estimated enrolment6 033 patientsSponsorMerck Sharp & Dohme LLC

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