NCT04910802

Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden

Concomitant HPV Vaccination and HPV Screening for Rapid Elimination of HPV Infection and Cervical Cancer in Sweden

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150,000 (estimated)
• Sponsor: Miriam Elfström · Other Government
• Sex: Female
• Age: 22 Years – 27 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate whether organised, concomitant HPV vaccination and HPV screening offered to all resident women aged 22-27 will result in a more rapid elimination of HPV infection in Sweden. This objective will be examined at the population level.

Detailed description

In Sweden, 150 women die of and 550 women are diagnosed with cervical cancer each year. The average age at diagnosis is about 55 years and every third woman is under 40 years of age. World-wide, there half a million new cases of cervical cancer each year. The underlying cause of cervical cancer is a human papillomavirus (HPV), an infection that can be prevented by vaccination. The first-generation vaccine protects against HPV infection of the two types (16 and 18) that cause to about 70% of all cervical cancer. Since 2015, a second-generation vaccine (Gardasil 9, Sanofi Pasteur MSD SNC) has been available that provides protection against 9 HPV types of which 7 types (16, 18, 31, 33, 35, 45, 52 and 58) cause 90% of all cervical cancer. In 2016, the World Health Organization (WHO) called on the countries of the world to eliminate cervical cancer as a public health problem. On 17 November 2020, all 194 WHO member states adopted a global strategy to increase the rate of elimination of cervical cancer. The strategy involves three main actions: vaccination, screening, and treatment. In Sweden, girls have been offered school-based vaccination against HPV with Gardasil 4 since 2012. Starting in the autumn of 2020, schoolboys have also been offered vaccination. Since 2019, the second-generation vaccine has been used in the school-based vaccination program. Sweden's vaccination strategy means that the virus will be eliminated among individuals born in 2007 and beyond. It will thus take another 20 years before Sweden can stop the infection in Sweden. Today, the infection continues to spread only among young adults. Studies have shown that vaccination up to age 26 can be effective and within the European Union, 10 out of 29 countries have a so-called catch-up on vaccination program targeting women over the age of 20 but such a catch-up has not been formally introduced in Sweden. The overall goal is to investigate whether offering women ages 22-26 years vaccination with Gardasil 9 in connection with screening may involve a faster eradication of cervical cancer as a public health problem in Sweden. A regional pilot study will be conducted in 2021 followed by a subsequent scale-up to other regions.

Conditions

• HPV Infection
• CIN 2/3
• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil9	Concomitant vaccination and HPV screening. Gardasil9 will be administered using standard dosage. 1 dose at recruitment and the 2nd dose 3 years later.

Timeline

• Start date: 2021-05-03
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2021-06-02
• Last updated: 2021-09-16

Locations

1 site across 1 country: Sweden