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 study about?

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.

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.

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).

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Region Vaestmanland	Vasteras	Sweden

Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Oerebro Laen	Orebro	Sweden
Vaestra Goetalandsregionen	Vänersborg	Sweden
Region Dalarna	Falun	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Region Norrbotten	Lulea	Sweden
Region Soermland	Nykoping	Sweden
Region Skane	Malmo	Sweden
Region Uppsala	Uppsala	Sweden
Region Jaemtland Haerjedalen	Ostersund	Sweden
Region Blekinge	Karlskrona	Sweden
Region Joenkoepings Laen	Jönköping	Sweden
Region Kronoberg	Vaxjo	Sweden
Region Halland	Varberg	Sweden
Region Gaevleborg	Gavle	Sweden
Roqnjj Gvpvvfw	Visby	Sweden
Rmifwa Kluplr Ldxs	Kalmar	Sweden
Rqlqzz Synxktxfq	Stockholm	Sweden
Roppoj Vjyvqdzmhqubj	Umea	Sweden
Rdhmhp Vqykamgug	Karlstad	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.04.2021

Trial locations

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 (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.

Trial ID:

2024-518857-41-00

NCT ID:

NCT04910802

Trial Phase:

Therapeutic confirmatory (Phase III)

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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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