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Study on HPV Vaccine and Screening to Reduce HPV Infection and Cervical Cancer in Swedish Women Aged 23-25

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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 effects of the Human Papillomavirus (HPV) vaccine, specifically the Gardasil 9 vaccine, in preventing HPV infection and related diseases such as cervical cancer. The Gardasil 9 vaccine is designed to protect against nine types of HPV, which are known to cause cervical cancer and other related conditions. The study aims to determine if offering both the HPV vaccine and regular HPV screening to women aged 23-25 in Sweden can help eliminate HPV infections more quickly.

Participants in the study will receive the Gardasil 9 vaccine, which is given as an injection. The study will monitor how many women receive the vaccine and how well they follow the vaccination schedule. The goal is to see if this combined approach of vaccination and screening can reduce the number of HPV infections and, ultimately, cases of cervical cancer in the population.

The study will take place over several years, with the aim of understanding the long-term benefits of this approach. By focusing on young women who are due for cervical cancer screening, the study hopes to provide valuable insights into the effectiveness of combining vaccination with regular health checks in preventing HPV-related diseases.

The research process

The trial runs in 6 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, participants will be informed about the purpose and procedures involved. Consent to participate is required from all eligible women aged 23-25 who are due for cervical cancer screening.
Step 2
Initial vaccination
Participants will receive the Gardasil 9 vaccine, which is a suspension for injection. This vaccine is designed to protect against the human papillomavirus (HPV), which can lead to cervical cancer and other related diseases.
The vaccine will be administered through one of the following methods: intravenous (into a vein), subcutaneous (under the skin), or intramuscular (into a muscle).
Step 3
Follow-up vaccinations
Participants will follow a specific schedule for receiving additional doses of the Gardasil 9 vaccine. Compliance with this schedule is important to ensure the effectiveness of the vaccination.
Step 4
HPV screening
Participants will undergo regular HPV screening as part of the study. This screening is part of the organized cervical cancer screening program and aims to detect any HPV infections early.
Step 5
Monitoring and evaluation
Throughout the study, participants will be monitored to evaluate the uptake of the HPV vaccine and compliance with the vaccination schedule. This will help assess the effectiveness of the combined vaccination and screening approach in eliminating HPV infections.
Step 6
Study completion
The study is expected to conclude by December 31, 2027. Participants will be informed about the outcomes and any further steps if necessary.

Who can join the trial?

5 criteria

You must be a woman.
You need to be between the ages of 23 and 25.
You should be living in the area where the study is being conducted.
You must be due for an invitation to the organized cervical cancer screening program.
You need to give your consent to participate in the study. Consent means you agree to take part after understanding what the study involves.

Who cannot join the trial?

3 criteria

Participants must be women aged 23-25.
Participants must not be men.
Participants must not belong to any vulnerable population groups. A vulnerable population refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

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Verified sites

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Verified
Region Gaevleborg
Gavle, Sweden
Verified
Region Halland
Varberg, Sweden
Responsive
Region Oestergoetland
Linkoping, Sweden

Trial locations

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Investigated drugs

HPV Vaccine is a medication used to protect against the human papillomavirus (HPV), which is a common virus that can lead to cervical cancer and other health issues. In this clinical trial, the HPV vaccine is being given to young women as part of a strategy to quickly reduce the number of HPV infections. The vaccine works by helping the body's immune system recognize and fight the virus if the person is exposed to it in the future. This trial is testing whether giving the vaccine alongside regular HPV screening can help eliminate the virus more effectively.

Human Papillomavirus Type 6 L1 Protein - Adsorbed - In The Form Of Virus-Like Particles Produced In Yeast Cells (Saccharomyces Cerevisiae Canade 3C-5 (Strain 1895)) By Rdna

What is already known about the treatment

HPV Vaccine – The HPV vaccine is administered as an injection, typically given in the upper arm. It is currently well-established in medical practice and literature as a preventive measure against human papillomavirus (HPV) infections and related diseases, such as cervical intraepithelial neoplasia grades 2 and 3, and cervical cancer. The main therapeutic indication for the HPV vaccine is to prevent these HPV-related conditions. At the molecular level, the vaccine works by stimulating the body's immune system to produce antibodies that recognize and fight the virus, preventing infection. It is classified pharmacologically as a vaccine, specifically targeting the prevention of viral infections.

Investigated diseases

Human Papillomavirus (HPV) Infection
HPV infection is caused by the human papillomavirus, which is a group of viruses that can infect the skin and mucous membranes. The infection often does not cause symptoms and can resolve on its own. However, some types of HPV can lead to the development of warts or precancerous lesions. If these lesions are not treated, they may progress to cancer, particularly cervical cancer. The virus is primarily spread through direct skin-to-skin contact, often during sexual activity. Persistent infection with high-risk HPV types is the main cause of cervical cancer.
Cervical Intraepithelial Neoplasia (CIN) Grade 2 and 3
Cervical intraepithelial neoplasia refers to the presence of abnormal cells on the surface of the cervix. CIN is graded on a scale from 1 to 3, with grade 2 and 3 indicating moderate to severe abnormalities. These changes are not cancer but can develop into cervical cancer if left untreated. CIN is often caused by persistent infection with high-risk types of HPV. The condition may not cause symptoms and is usually detected through cervical screening tests. Monitoring and treatment are important to prevent progression to cancer.
Cervical Cancer
Cervical cancer occurs when abnormal cells on the cervix grow uncontrollably. It is most commonly caused by persistent infection with high-risk types of HPV. The disease typically progresses slowly, starting as precancerous changes known as cervical intraepithelial neoplasia. Over time, these changes can develop into invasive cancer. Early stages of cervical cancer may not cause symptoms, but advanced stages can lead to abnormal bleeding, pelvic pain, or other symptoms. Regular screening can help detect precancerous changes and prevent the development of cervical cancer.