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

Registered drug

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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 effectiveness of a vaccine called Cervarix in preventing infections caused by the Human Papillomavirus (HPV), specifically types 16 and 18. These types of HPV are known to cause certain types of cancers and other health issues. The study is particularly interested in how well the vaccine works in preventing anal HPV infections among men who have sex with men, a group that can be at higher risk for these infections.

The purpose of the study is to assess how effective the Cervarix vaccine is in preventing HPV infections. Participants in the study will receive the vaccine through an injection into the muscle. The study will compare the presence of HPV types 16 and 18 in those who have been vaccinated with those who have not. This will help researchers understand the vaccine's effectiveness in real-world conditions.

Participants will be involved in the study for a period of up to 24 months. During this time, they will receive the vaccine and attend follow-up visits to monitor their health and check for the presence of HPV. The study aims to provide valuable information on the benefits of the Cervarix vaccine in preventing HPV infections, which can lead to serious health problems if left untreated.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be male, aged 19-26 years, and have reported sexual activity with other men in the preceding six months. Attendance at the Sexual Health Clinic in Amsterdam is required.
Informed consent is obtained, ensuring understanding and agreement to participate in the study.
Step 2
First vaccination visit
The first visit involves receiving the Cervarix vaccine, which is a suspension for injection. The vaccine is administered as an intramuscular injection.
Participants are required to remain in or around Amsterdam for the next two years to ensure follow-up visits can be attended.
Step 3
Online questionnaire
At month 15, participants complete an online questionnaire. This step is crucial for gathering data on health and any changes since the start of the study.
Step 4
Final study visit
A final study visit is scheduled at month 24. During this visit, the effectiveness of the vaccine is assessed by measuring the presence of HPV-16 and HPV-18.
Participants' health is monitored, and any side effects or health changes are documented.

Who can join the trial?

10 criteria

Must be male.
Must have had sexual contact with other men in the last 6 months.
Must be between the ages of 19-26 years for Group 1 or 21-28 years for Group 2.
Must be visiting the Sexual Health Clinic in Amsterdam.
Must agree to receive a preventive vaccine for HPV (a virus that can cause infections).
Must provide informed consent (agree to participate after understanding the study details).
For Group 1, must plan to stay in or around Amsterdam for the next two years.
For Group 1, must be willing and able to return for one more visit for vaccination.
For Group 1, must be willing and able to complete an online questionnaire at month 15.
For Group 1, must be willing and able to return for a final study visit at month 24.

Who cannot join the trial?

4 criteria

Participants must be **men** who have sex with men.
Participants must be **aged 19-26 years**.
Participants must be **healthy** and not currently infected with **HPV** (Human Papillomavirus).
Participants must not be part of a **vulnerable population**. This means they should not be in a situation where they are unable to make informed decisions about their participation.

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Investigated drugs

Cervarix is a vaccine designed to protect against certain types of human papillomavirus (HPV), specifically types 16 and 18. These types of HPV are known to cause anal and cervical cancers. In this clinical trial, the vaccine is being tested to see how well it works in preventing anal HPV infections in men who have sex with men, aged 19 to 26 years. The goal is to see if the vaccine can effectively reduce the risk of these infections in this group.

What is already known about the treatment

Cervarix – Cervarix is administered as an injection, typically given in the upper arm. It is currently recognized in medical literature as a vaccine used to prevent infections caused by certain types of human papillomavirus (HPV), specifically types 16 and 18, which are known to cause cancer. The main therapeutic indication for Cervarix is the prevention of HPV infection, particularly among healthy individuals, including men who have sex with men. At the molecular level, Cervarix works by stimulating the body's immune system to produce antibodies that target and neutralize the HPV virus, preventing it from causing infection. It is classified pharmacologically as a vaccine.

Investigated diseases

HPV infection – Human Papillomavirus (HPV) infection is caused by a group of viruses that affect the skin and moist membranes lining the body, such as the cervix, anus, mouth, and throat. The virus is transmitted through direct skin-to-skin contact, often during sexual activity. Once the virus enters the body, it can remain dormant or cause cell changes that may lead to warts or other growths. In some cases, these changes can progress over time to more serious conditions, such as precancerous lesions. The infection can be asymptomatic, meaning individuals may not be aware they are infected. The body's immune system often clears the virus naturally, but persistent infection with certain types of HPV can lead to complications.