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

NCT04910802RecruitingPHASE4INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Miriam Elfström

Enrollment

150000

Start Date

2021-05-03

Completion Date

2025-12-31

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Gardasil9

Conditions

HPV InfectionCIN 2/3Cervical Cancer

Eligibility

Age Range

22 Years – 27 Years

Sex

FEMALE

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:

1. 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
2. Known history of immune-related disorders
3. Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
4. Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
5. Current pregnancy (reported)
6. Women with a total hysterectomy

Outcome Measures

Primary Outcomes

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.

Time frame: Measured at recruitment.

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.

Time frame: Measured 3 years after recruitment, at the second cervical screening attendance.

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.

Time frame: Measure 6 years after recruitment, at the third cervical screening attendance.

Secondary Outcomes

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.

Time frame: Measured at recruitment, and subsequently at 3 year intervals.

Consumption of resources

Number of screening and treatment visits.

Time frame: Measured at recruitment, and subsequently at 3 year intervals.

Number of women with obstetrical complications

Obstetrical complications such as preterm births measured through registry linkages.

Time frame: Measured at recruitment, and subsequently at 3 year intervals.

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.

Time frame: Measured at recruitment, and subsequently at 3 year intervals.

Locations

Cancer prevention, screening, and counseling unit, Regional Cancer Center of Stockholm-Gotland, Stockholm, Sweden