Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
Primary Purpose
HPV Infection, CIN 2/3, Cervical Cancer
Status
Recruiting
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Gardasil9
Sponsored by
About this trial
This is an interventional prevention trial for HPV Infection
Eligibility Criteria
Inclusion Criteria:
- Eligible women will include resident women within the age range of 22-26, who have not opted out of the screening program and who consent to participate in the study.
Women who respond to the invitation and attend screening will be screened with HPV testing by the current routine practise. Women who consent to participate will also be offered HPV vaccination. The HPV vaccine (Gardasil 9) will be offered regardless of whether the woman reports having had prior vaccination with a first-generation vaccine (Gardasil 4) and regardless of screening test result.
Exclusion Criteria:
- Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine.For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate
- Known history of immune-related disorders
- Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
- Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
- Current pregnancy (reported)
- Women with a total hysterectomy
Sites / Locations
- Cancer prevention, screening, and counseling unit, Regional Cancer Center of Stockholm-GotlandRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HPV-vaccination
Arm Description
Women ages 22-26 will be offered concomitant vaccination (1 dose of Gardasil9) and HPV screening. A second dose of Gardasil9 will be administered 3 years later.
Outcomes
Primary Outcome Measures
Prevalence of HPV
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Prevalence of HPV
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Prevalence of HPV
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Secondary Outcome Measures
Number of women with histopathologically confirmed cervical intraepithelial neoplasia grade 2, 3, or cervical cancer (CIN2+)
CIN2+ measured through registry linkages, by HPV type in the lesion.
Consumption of resources
Number of screening and treatment visits.
Number of women with obstetrical complications
Obstetrical complications such as preterm births measured through registry linkages.
Number of women with cervical specimens found to be benign
Treatments for cervical abnormalities, measured as excised cervical specimens, found to be benign. Measured through registry linkages.
Full Information
NCT ID
NCT04910802
First Posted
May 1, 2021
Last Updated
September 9, 2021
Sponsor
Miriam Elfström
Collaborators
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04910802
Brief Title
Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
Official Title
Concomitant HPV Vaccination and HPV Screening for Rapid Elimination of HPV Infection and Cervical Cancer in Sweden
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Miriam Elfström
Collaborators
Karolinska University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection, CIN 2/3, Cervical Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
All women in the targeted age-range will be offered vaccination in conjunction with screening.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HPV-vaccination
Arm Type
Experimental
Arm Description
Women ages 22-26 will be offered concomitant vaccination (1 dose of Gardasil9) and HPV screening. A second dose of Gardasil9 will be administered 3 years later.
Intervention Type
Biological
Intervention Name(s)
Gardasil9
Intervention Description
Concomitant vaccination and HPV screening. Gardasil9 will be administered using standard dosage. 1 dose at recruitment and the 2nd dose 3 years later.
Primary Outcome Measure Information:
Title
Prevalence of HPV
Description
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Time Frame
Measured at recruitment.
Title
Prevalence of HPV
Description
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Time Frame
Measured 3 years after recruitment, at the second cervical screening attendance.
Title
Prevalence of HPV
Description
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Time Frame
Measure 6 years after recruitment, at the third cervical screening attendance.
Secondary Outcome Measure Information:
Title
Number of women with histopathologically confirmed cervical intraepithelial neoplasia grade 2, 3, or cervical cancer (CIN2+)
Description
CIN2+ measured through registry linkages, by HPV type in the lesion.
Time Frame
Measured at recruitment, and subsequently at 3 year intervals.
Title
Consumption of resources
Description
Number of screening and treatment visits.
Time Frame
Measured at recruitment, and subsequently at 3 year intervals.
Title
Number of women with obstetrical complications
Description
Obstetrical complications such as preterm births measured through registry linkages.
Time Frame
Measured at recruitment, and subsequently at 3 year intervals.
Title
Number of women with cervical specimens found to be benign
Description
Treatments for cervical abnormalities, measured as excised cervical specimens, found to be benign. Measured through registry linkages.
Time Frame
Measured at recruitment, and subsequently at 3 year intervals.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender eligibility is based on the sex coded in the personal identification number used in civil society in Sweden
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible women will include resident women within the age range of 22-26, who have not opted out of the screening program and who consent to participate in the study.
Women who respond to the invitation and attend screening will be screened with HPV testing by the current routine practise. Women who consent to participate will also be offered HPV vaccination. The HPV vaccine (Gardasil 9) will be offered regardless of whether the woman reports having had prior vaccination with a first-generation vaccine (Gardasil 4) and regardless of screening test result.
Exclusion Criteria:
Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine.For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate
Known history of immune-related disorders
Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
Current pregnancy (reported)
Women with a total hysterectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Elfström, PhD
Phone
+46703816277
Email
miriam.elfstrom@sll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Andersson, PhD
Phone
+46768871126
Email
helena.t.andersson@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joakim Dillner, MD, PhD
Organizational Affiliation
Karolinska University Hospital Laboratory
Official's Role
Study Director
Facility Information:
Facility Name
Cancer prevention, screening, and counseling unit, Regional Cancer Center of Stockholm-Gotland
City
Stockholm
ZIP/Postal Code
10239
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malin Vikström, BSN
Phone
+46(0)8-123 131 14
Email
malin.vikstrom@sll.se
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Documents related to the study can be shared. Data, once collected, will be made available.
IPD Sharing Time Frame
The study protocol and informed consent form are available. The SAP will be made available and the analytic code will be available once the first round of results have been analyzed.
IPD Sharing Access Criteria
Data can be shared with other researchers upon written request. Possibilities to share the data on a digital platform will be investigated.
Learn more about this trial
Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
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