#1 Clinical Trials Search in Europe

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

3 1 1

What is this study about?

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.

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 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 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 second vaccination

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

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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Berlin Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Velocity Clinical Research Luebeck GmbH Luebeck Germany
University Of Antwerp Antwerp Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Eap Osona Sud Alt Congost S.L.P. Centelles Spain
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Hôpital Pontchaillou-CHU Rennes Rennes France
Cenwli Hqppbopdjsy Ufauecgbuicsy Dw Dztme Dijon France
Fkewbxkv ntpudiqzr Mlmcb a Hhyttwd Prague Czechia
Aygseaausx Pcimdygz Hsqsuxvb Dx Pouho Paris France
Uqbcohxqqt Mrxaayu Cwdzbk Hvzqtqwwwmebdfbtd Hamburg Germany
Ivnonp Ibrarbki Fxmjpmdeccazb Oiyqhvjfcvu Rome Italy
Uiaqhjwvwg Dkfld Sviab Dk Rjhh Lx Snehpafz Rome Italy
Itjnrgts Cxvqpj Dapaocbbyxkaxhnto L'hospitalet De Llobregat Spain
Ctbjfry aonbhzdglo gdvjdbdtkuh a pzrvqzxf pcgi svpwzx Brno-Stred Czechia
G Cycakaa Oykdmij shdksi Olomouc Czechia
Hcmlbuwu Uqwzzcqgkemkj Hkvcrmhg Thojr y Pluczm Ipkkblwq Ccraxn ddqknqrmkjusxjmpo (bbcv Badalona Spain
Muldgxaa sepkdf Prague Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
26.02.2020
Czechia Czechia
Not recruiting
26.02.2020
France France
Not recruiting
26.02.2020
Germany Germany
Not recruiting
26.02.2020
Italy Italy
Not recruiting
26.02.2020
Spain Spain
Not recruiting
26.02.2020

Trial locations

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.

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 ID:
2022-501974-21-00
Protocol code:
V503-049
NCT ID:
NCT04199689
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of HPV antibody response in urine samples before and after HPV 9-valent vaccine in people with Human Papillomavirus infection

    Recruiting

    2 1 1 1
    Investigated drugs:
    Belgium

  • Study on the Effectiveness of the HPV Vaccine in Preventing HPV Infections in Men Who Have Sex with Men Aged 19-26 Using Cervarix

    Recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands